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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02675452
Registration number
NCT02675452
Ethics application status
Date submitted
22/12/2015
Date registered
5/02/2016
Date last updated
26/02/2024
Titles & IDs
Public title
AMG 176 First in Human Trial in Participants With Relapsed or Refractory Multiple Myeloma and Participants With Relapsed or Refractory Acute Myeloid Leukemia
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Scientific title
A Phase 1 First in Human Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 176 in Subjects With Relapsed or Refractory Multiple Myeloma and Subjects With Relapsed or Refractory Acute Myeloid Leukemia
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Secondary ID [1]
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2015-004777-32
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Secondary ID [2]
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20150161
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Relapsed or Refractory Multiple Myeloma
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Relapsed or Refractory Acute Myeloid Leukemia
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Condition category
Condition code
Cancer
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0
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Leukaemia - Acute leukaemia
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Cancer
0
0
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0
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Leukaemia - Chronic leukaemia
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Cancer
0
0
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0
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Children's - Leukaemia & Lymphoma
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Cancer
0
0
0
0
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Other cancer types
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - AMG 176
Treatment: Drugs - Azacitidine
Treatment: Drugs - Itraconazole
Experimental: AMG 176 - Part 1a - Part 1a - Participants with muliple myeloma (MM) administered AMG 176 as an intravenous (IV) infusion for two-consecutive days (QD2) followed by a 5 days break.
Experimental: AMG 176 - Part 1b - Part 1b - Participants with multiple myeloma (MM) administered AMG 176 as an intravenous (IV) infusion, once a week (QW) followed by 6 days break.
Experimental: AMG 176 - Part 3a - Part 3a - Participants with acute myeloid leukemia (AML) administered AMG 176 as an intravenous (IV) infusion once a day, for two-consecutive days (QD2) followed by a 5 day break.
Experimental: AMG 176 - Part 3b - Part 3b - Participants with acute myeloid leukemia (AML) administered AMG 176 as an intravenous (IV) infusion, once a week (QW) followed by 6 days break.
Experimental: AMG 176 - Part 3c - Part 3c - Participants in Japan only with acute myeloid leukemia (AML) administered AMG 176 as an intravenous (IV) infusion, once a week (QW) followed by 6 days break.
Experimental: AMG 176 - Part 3d - Part 3d - Participants in the United States with acute myeloid leukemia (AML) administered AMG 176 as an intravenous (IV) infusion, once a week (QW), for 3 weeks, in combination with itraconazole.
Experimental: AMG 176 - Part 4 - Part 4 - Participants with acute myeloid leukemia (AML) administered AMG 176 as an intravenous (IV) infusion, either once a week (QW) followed by 6 days break, or once a day, for two-consecutive days (QD2), in combination with azacitidine.
Experimental: AMG 176 - Part 5 - Part 5 - Participants with acute myeloid leukemia (AML) administered AMG 176 as an intravenous (IV) infusion at the maximum tolerated combination dose from Part 4, either once a week (QW) followed by 6 days break, or once a day, for two-consecutive days (QD2), in combination with azacitidine.
Treatment: Drugs: AMG 176
Study Drug
Treatment: Drugs: Azacitidine
Non-investigational product
Treatment: Drugs: Itraconazole
Non-investigational product
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Multiple Myeloma (MM) Part 1a Incidence of dose-limiting toxicities (DLTs)
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Assessment method [1]
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Evaluate the safety and tolerability of AMG 176 monotherapy in subjects with relapsed or refractory MM and determine the maximum tolerated dose (MTD) for two-consecutive days per week dosing schedule (QD2)
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Timepoint [1]
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Up to 6 months
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Primary outcome [2]
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MM Part 1a Incidence of treatment-related adverse events
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Assessment method [2]
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Evaluate the safety and tolerability of AMG 176 monotherapy in subjects with relapsed or refractory MM and determine the MTD for QD2
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Timepoint [2]
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Up to 18 months
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Primary outcome [3]
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MM Part 1a Incidence of treatment-emergent adverse events
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Assessment method [3]
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Evaluate the safety and tolerability of AMG 176 monotherapy in subjects with relapsed or refractory MM and determine the MTD for QD2
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Timepoint [3]
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Up to 18 months
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Primary outcome [4]
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MM Part 1a Incidence of clinically significant changes in vital signs
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Assessment method [4]
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Evaluate the safety and tolerability of AMG 176 monotherapy in subjects with relapsed or refractory MM and determine the MTD for QD2
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Timepoint [4]
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Up to 6 months
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Primary outcome [5]
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MM Part 1a Incidence of clinically significant changes in electrocardiograms (ECGs)
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Assessment method [5]
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Evaluate the safety and tolerability of AMG 176 monotherapy in subjects with relapsed or refractory MM and determine the MTD for QD2
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Timepoint [5]
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Up to 6 months
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Primary outcome [6]
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MM Part 1a Incidence of clinically significant changes in clinical laboratory tests
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Assessment method [6]
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Evaluate the safety and tolerability of AMG 176 monotherapy in subjects with relapsed or refractory MM and determine the MTD for QD2
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Timepoint [6]
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Up to 6 months
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Primary outcome [7]
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MM Part 1a Pharmacokinetic (PK) parameters for AMG 176: maximum observed concentration (Cmax)
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Assessment method [7]
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Evaluate the pharmacokinetics (PK) of AMG 176 when administered as monotherapy QD2
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Timepoint [7]
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1 month on treatment
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Primary outcome [8]
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MM Part 1a Pharmacokinetic parameters for AMG 176: area under the concentration-time curve (AUC)
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Assessment method [8]
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Evaluate the PK of AMG 176 when administered as monotherapy QD2
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Timepoint [8]
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1 month on treatment
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Primary outcome [9]
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MM Part 1a Pharmacokinetic parameters for AMG 176: clearance (CL)
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Assessment method [9]
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Evaluate the PK of AMG 176 when administered as monotherapy QD2
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Timepoint [9]
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1 month on treatment
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Primary outcome [10]
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MM Part 1a Pharmacokinetic parameters for AMG 176: half-life (t1/2)
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Assessment method [10]
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Evaluate the PK of AMG 176 when administered as monotherapy QD2
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Timepoint [10]
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1 month on treatment
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Primary outcome [11]
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MM Part 1b Incidence of DLTs
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Assessment method [11]
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Evaluate the safety and tolerability of AMG 176 monotherapy in subjects with relapsed or refractory MM and determine the MTD for a once weekly (QW) dosing schedule
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Timepoint [11]
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Up to 6 months
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Primary outcome [12]
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MM Part 1b Incidence of treatment-related adverse events
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Assessment method [12]
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Evaluate the safety and tolerability of AMG 176 monotherapy in subjects with relapsed or refractory MM and determine the MTD for a QW dosing schedule
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Timepoint [12]
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Up to 18 months
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Primary outcome [13]
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MM Part 1b Incidence of treatment-emergent adverse events
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Assessment method [13]
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0
Evaluate the safety and tolerability of AMG 176 monotherapy in subjects with relapsed or refractory MM and determine the MTD for a QW dosing schedule
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Timepoint [13]
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Up to 18 months
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Primary outcome [14]
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MM Part 1b Incidence of clinically significant changes in vital signs
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Assessment method [14]
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Evaluate the safety and tolerability of AMG 176 monotherapy in subjects with relapsed or refractory MM and determine the MTD for a QW dosing schedule
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Timepoint [14]
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Up to 6 months
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Primary outcome [15]
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MM Part 1b Incidence of clinically significant changes in ECGs
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Assessment method [15]
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0
Evaluate the safety and tolerability of AMG 176 monotherapy in subjects with relapsed or refractory MM and determine the MTD for a QW dosing schedule
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Timepoint [15]
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Up to 6 months
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Primary outcome [16]
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MM Part 1b Incidence of clinically significant changes in clinical laboratory tests
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Assessment method [16]
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Evaluate the safety and tolerability of AMG 176 monotherapy in subjects with relapsed or refractory MM and determine the MTD for a QW dosing schedule
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Timepoint [16]
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Up to 6 months
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Primary outcome [17]
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MM Part 1b Pharmacokinetic parameters for AMG 176: Cmax
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Assessment method [17]
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Evaluate the PK of AMG 176 when administered as monotherapy QW
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Timepoint [17]
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1 month on treatment
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Primary outcome [18]
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MM Part 1b Pharmacokinetic parameters for AMG 176: AUC
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Assessment method [18]
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Evaluate the PK of AMG 176 when administered as monotherapy QW
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Timepoint [18]
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1 month on treatment
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Primary outcome [19]
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MM Part 1b Pharmacokinetic parameters for AMG 176: CL
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Assessment method [19]
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Evaluate the PK of AMG 176 when administered as monotherapy QW
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Timepoint [19]
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1 month on treatment
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Primary outcome [20]
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MM Part 1b Pharmacokinetic parameters for AMG 176: t1/2
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Assessment method [20]
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Evaluate the PK of AMG 176 when administered as monotherapy QW
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Timepoint [20]
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1 month on treatment
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Primary outcome [21]
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Acute Myeloid Leukemia (AML) Part 3a Incidence of DLTs
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Assessment method [21]
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0
Evaluate the safety and tolerability of AMG 176 monotherapy in subjects with relapsed or refractory AML and determine the MTD for QD2 dosing as a monotherapy in subjects with relapsed or refractory AML
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Timepoint [21]
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Up to 6 months
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Primary outcome [22]
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0
AML Part 3a Incidence of treatment-related adverse events
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Assessment method [22]
0
0
Evaluate the safety and tolerability of AMG 176 monotherapy in subjects with relapsed or refractory AML and determine the MTD for QD2 dosing as a monotherapy in subjects with relapsed or refractory AML
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Timepoint [22]
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0
Up to 18 months
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Primary outcome [23]
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0
AML Part 3a Incidence of treatment-emergent adverse events
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Assessment method [23]
0
0
Evaluate the safety and tolerability of AMG 176 monotherapy in subjects with relapsed or refractory AML and determine the MTD for QD2 dosing as a monotherapy in subjects with relapsed or refractory AML
Query!
Timepoint [23]
0
0
Up to 18 months
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Primary outcome [24]
0
0
AML Part 3a Incidence of clinically significant changes in vital signs
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Assessment method [24]
0
0
Evaluate the safety and tolerability of AMG 176 monotherapy in subjects with relapsed or refractory AML and determine the MTD for QD2 dosing as a monotherapy in subjects with relapsed or refractory AML
Query!
Timepoint [24]
0
0
Up to 6 months
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Primary outcome [25]
0
0
AML Part 3a Incidence of clinically significant changes in ECGs
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Assessment method [25]
0
0
Evaluate the safety and tolerability of AMG 176 monotherapy in subjects with relapsed or refractory AML and determine the MTD for QD2 dosing as a monotherapy in subjects with relapsed or refractory AML
Query!
Timepoint [25]
0
0
Up to 6 months
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Primary outcome [26]
0
0
AML Part 3a Incidence of clinically significant changes in clinical laboratory tests
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Assessment method [26]
0
0
Evaluate the safety and tolerability of AMG 176 monotherapy in subjects with relapsed or refractory AML and determine the MTD for QD2 dosing as a monotherapy in subjects with relapsed or refractory AML
Query!
Timepoint [26]
0
0
Up to 6 months
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Primary outcome [27]
0
0
AML Part 3a Pharmacokinetic parameters for AMG 176: Cmax
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Assessment method [27]
0
0
Evaluate the PK of AMG 176 when administered as monotherapy QD2
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Timepoint [27]
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0
1 month on treatment
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Primary outcome [28]
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0
AML Part 3a Pharmacokinetic parameters for AMG 176: AUC
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Assessment method [28]
0
0
Evaluate the PK of AMG 176 when administered as monotherapy QD2
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Timepoint [28]
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0
1 month on treatment
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Primary outcome [29]
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0
AML Part 3a Pharmacokinetic parameters for AMG 176: CL
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Assessment method [29]
0
0
Evaluate the PK of AMG 176 when administered as monotherapy QD2
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Timepoint [29]
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0
1 month on treatment
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Primary outcome [30]
0
0
AML Part 3a Pharmacokinetic parameters for AMG 176: t1/2
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Assessment method [30]
0
0
Evaluate the PK of AMG 176 when administered as monotherapy QD2
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Timepoint [30]
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0
1 month on treatment
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Primary outcome [31]
0
0
AML Part 3b Incidence of DLTs
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Assessment method [31]
0
0
Evaluate the safety and tolerability of AMG 176 monotherapy (QW) in subjects with relapsed or refractory AML
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Timepoint [31]
0
0
Up to 6 months
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Primary outcome [32]
0
0
AML Part 3b Incidence of treatment-related adverse events
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Assessment method [32]
0
0
Evaluate the safety and tolerability of AMG 176 monotherapy (QW) in subjects with relapsed or refractory AML
Query!
Timepoint [32]
0
0
Up to 18 months
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Primary outcome [33]
0
0
AML Part 3b Incidence of treatment-emergent adverse events
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Assessment method [33]
0
0
Evaluate the safety and tolerability of AMG 176 monotherapy (QW) in subjects with relapsed or refractory AML
Query!
Timepoint [33]
0
0
Up to 18 months
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Primary outcome [34]
0
0
AML Part 3b Incidence of clinically significant changes in vital signs
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Assessment method [34]
0
0
Evaluate the safety and tolerability of AMG 176 monotherapy (QW) in subjects with relapsed or refractory AML
Query!
Timepoint [34]
0
0
Up to 6 months
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Primary outcome [35]
0
0
AML Part 3b Incidence of clinically significant changes in ECGs
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Assessment method [35]
0
0
Evaluate the safety and tolerability of AMG 176 monotherapy (QW) in subjects with relapsed or refractory AML
Query!
Timepoint [35]
0
0
Up to 6 months
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Primary outcome [36]
0
0
AML Part 3b Incidence of clinically significant changes in clinical laboratory tests
Query!
Assessment method [36]
0
0
Evaluate the safety and tolerability of AMG 176 monotherapy (QW) in subjects with relapsed or refractory AML
Query!
Timepoint [36]
0
0
Up to 6 months
Query!
Primary outcome [37]
0
0
AML Part 3b Pharmacokinetic parameters for AMG 176: Cmax
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Assessment method [37]
0
0
Evaluate the PK of AMG 176 when administered as monotherapy QW
Query!
Timepoint [37]
0
0
1 month on treatment
Query!
Primary outcome [38]
0
0
AML Part 3b Pharmacokinetic parameters for AMG 176: AUC
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Assessment method [38]
0
0
Evaluate the PK of AMG 176 when administered as monotherapy QW
Query!
Timepoint [38]
0
0
1 month on treatment
Query!
Primary outcome [39]
0
0
AML Part 3b Pharmacokinetic parameters for AMG 176: CL
Query!
Assessment method [39]
0
0
Evaluate the PK of AMG 176 when administered as monotherapy QW
Query!
Timepoint [39]
0
0
1 month on treatment
Query!
Primary outcome [40]
0
0
AML Part 3b Pharmacokinetic parameters for AMG 176: t1/2
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Assessment method [40]
0
0
Evaluate the PK of AMG 176 when administered as monotherapy QW
Query!
Timepoint [40]
0
0
1 month on treatment
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Primary outcome [41]
0
0
AML Part 3c Incidence of DLTs
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Assessment method [41]
0
0
Evaluate the safety and tolerability of AMG 176 QW monotherapy in participants in Japan with relapsed or refractory AML
Query!
Timepoint [41]
0
0
Up to 6 months
Query!
Primary outcome [42]
0
0
AML Part 3c Incidence of treatment-related adverse events
Query!
Assessment method [42]
0
0
Evaluate the safety and tolerability of AMG 176 QW monotherapy in participants in Japan with relapsed or refractory AML
Query!
Timepoint [42]
0
0
Up to 18 months
Query!
Primary outcome [43]
0
0
AML Part 3c Incidence of treatment-emergent adverse events
Query!
Assessment method [43]
0
0
Evaluate the safety and tolerability of AMG 176 QW monotherapy in participants in Japan with relapsed or refractory AML
Query!
Timepoint [43]
0
0
Up to 18 months
Query!
Primary outcome [44]
0
0
AML Part 3c Incidence of clinically significant changes in vital signs
Query!
Assessment method [44]
0
0
Evaluate the safety and tolerability of AMG 176 QW monotherapy in participants in Japan with relapsed or refractory AML
Query!
Timepoint [44]
0
0
Up to 6 months
Query!
Primary outcome [45]
0
0
AML Part 3c Incidence of clinically significant changes in ECGs
Query!
Assessment method [45]
0
0
Evaluate the safety and tolerability of AMG 176 QW monotherapy in participants in Japan with relapsed or refractory AML
Query!
Timepoint [45]
0
0
Up to 6 months
Query!
Primary outcome [46]
0
0
AML Part 3c Incidence of clinically significant changes in clinical laboratory tests
Query!
Assessment method [46]
0
0
Evaluate the safety and tolerability of AMG 176 QW monotherapy in participants in Japan with relapsed or refractory AML
Query!
Timepoint [46]
0
0
Up to 6 months
Query!
Primary outcome [47]
0
0
AML Part 3c Pharmacokinetic parameters for AMG 176: Cmax
Query!
Assessment method [47]
0
0
Evaluate the PK of AMG 176 when administered as monotherapy (QW) in Japan
Query!
Timepoint [47]
0
0
1 month on treatment
Query!
Primary outcome [48]
0
0
AML Part 3c Pharmacokinetic parameters for AMG 176: AUC
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Assessment method [48]
0
0
Evaluate the PK of AMG 176 when administered as monotherapy (QW) in Japan
Query!
Timepoint [48]
0
0
1 month on treatment
Query!
Primary outcome [49]
0
0
AML Part 3c Pharmacokinetic parameters for AMG 176: CL
Query!
Assessment method [49]
0
0
Evaluate the PK of AMG 176 when administered as monotherapy (QW) in Japan
Query!
Timepoint [49]
0
0
1 month on treatment
Query!
Primary outcome [50]
0
0
AML Part 3c Pharmacokinetic parameters for AMG 176: t1/2
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Assessment method [50]
0
0
Evaluate the PK of AMG 176 when administered as monotherapy (QW) in Japan
Query!
Timepoint [50]
0
0
1 month on treatment
Query!
Primary outcome [51]
0
0
AML Part 3d Pharmacokinetic parameters for AMG 176 and itraconazole: Cmax
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Assessment method [51]
0
0
Evaluate the PK of AMG 176 when given alone and in combination with itraconazole in subjects with AML
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Timepoint [51]
0
0
3 weeks on treatment
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Primary outcome [52]
0
0
AML Part 3d Pharmacokinetic parameters for AMG 176 and itraconazole: AUC
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Assessment method [52]
0
0
Evaluate the PK of AMG 176 when given alone and in combination with itraconazole in subjects with AML
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Timepoint [52]
0
0
3 weeks on treatment
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Primary outcome [53]
0
0
AML Part 3d Pharmacokinetic parameters for AMG 176 and itraconazole: CL
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Assessment method [53]
0
0
Evaluate the PK of AMG 176 when given alone and in combination with itraconazole in subjects with AML
Query!
Timepoint [53]
0
0
3 weeks on treatment
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Primary outcome [54]
0
0
AML Part 3d Pharmacokinetic parameters for AMG 176 and itraconazole: t1/2
Query!
Assessment method [54]
0
0
Evaluate the PK of AMG 176 when given alone and in combination with itraconazole in subjects with AML
Query!
Timepoint [54]
0
0
3 weeks on treatment
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Primary outcome [55]
0
0
AML Part 4 Incidence of DLTs
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Assessment method [55]
0
0
Evaluate the safety and tolerability of AMG 176 in combination with azacitidine in subjects with relapsed or refractory AML and determine the maximum tolerated combination dose (MTCD) of AMG 176 in combination with azacitidine
Query!
Timepoint [55]
0
0
Up to 6 months
Query!
Primary outcome [56]
0
0
AML Part 4 Incidence of treatment-related adverse events
Query!
Assessment method [56]
0
0
Evaluate the safety and tolerability of AMG 176 in combination with azacitidine in subjects with relapsed or refractory AML and determine the MTCD of AMG 176 in combination with azacitidine
Query!
Timepoint [56]
0
0
Up to 18 months
Query!
Primary outcome [57]
0
0
AML Part 4 Incidence of treatment-emergent adverse events
Query!
Assessment method [57]
0
0
Evaluate the safety and tolerability of AMG 176 in combination with azacitidine in subjects with relapsed or refractory AML and determine the MTCD of AMG 176 in combination with azacitidine
Query!
Timepoint [57]
0
0
Up to 18 months
Query!
Primary outcome [58]
0
0
AML Part 4 Incidence of clinically significant changes in vital signs
Query!
Assessment method [58]
0
0
Evaluate the safety and tolerability of AMG 176 in combination with azacitidine in subjects with relapsed or refractory AML and determine the MTCD of AMG 176 in combination with azacitidine
Query!
Timepoint [58]
0
0
Up to 6 months
Query!
Primary outcome [59]
0
0
AML Part 4 Incidence of clinically significant changes in ECGs
Query!
Assessment method [59]
0
0
Evaluate the safety and tolerability of AMG 176 in combination with azacitidine in subjects with relapsed or refractory AML and determine the MTCD of AMG 176 in combination with azacitidine
Query!
Timepoint [59]
0
0
Up to 6 months
Query!
Primary outcome [60]
0
0
AML Part 4 Incidence of clinically significant changes in clinical laboratory tests
Query!
Assessment method [60]
0
0
Evaluate the safety and tolerability of AMG 176 in combination with azacitidine in subjects with relapsed or refractory AML and determine the MTCD of AMG 176 in combination with azacitidine
Query!
Timepoint [60]
0
0
Up to 6 months
Query!
Primary outcome [61]
0
0
AML Part 4 Pharmacokinetic parameters for AMG 176 and azacitidine: Cmax
Query!
Assessment method [61]
0
0
Evaluate the PK of AMG 176 and azacitidine when administered in combination
Query!
Timepoint [61]
0
0
1 month on treatment
Query!
Primary outcome [62]
0
0
AML Part 4 Pharmacokinetic parameters for AMG 176 and azacitidine: AUC
Query!
Assessment method [62]
0
0
Evaluate the PK of AMG 176 and azacitidine when administered in combination
Query!
Timepoint [62]
0
0
1 month on treatment
Query!
Primary outcome [63]
0
0
AML Part 4 Pharmacokinetic parameters for AMG 176 and azacitidine: CL
Query!
Assessment method [63]
0
0
Evaluate the PK of AMG 176 and azacitidine when administered in combination
Query!
Timepoint [63]
0
0
1 month on treatment
Query!
Primary outcome [64]
0
0
AML Part 4 Pharmacokinetic parameters for AMG 176 and azacitidine: t1/2
Query!
Assessment method [64]
0
0
Evaluate the PK of AMG 176 and azacitidine when administered in combination
Query!
Timepoint [64]
0
0
1 month on treatment
Query!
Primary outcome [65]
0
0
AML Part 5 Incidence of treatment-related adverse events
Query!
Assessment method [65]
0
0
Evaluate the safety and tolerability of AMG 176 in combination with azacitidine in subjects with relapsed or refractory AML
Query!
Timepoint [65]
0
0
Up to 18 months
Query!
Primary outcome [66]
0
0
AML Part 5 Incidence of treatment-emergent adverse events
Query!
Assessment method [66]
0
0
Evaluate the safety and tolerability of AMG 176 in combination with azacitidine in subjects with relapsed or refractory AML
Query!
Timepoint [66]
0
0
Up to 18 months
Query!
Primary outcome [67]
0
0
AML Part 5 Incidence of clinically significant changes in vital signs
Query!
Assessment method [67]
0
0
Evaluate the safety and tolerability of AMG 176 in combination with azacitidine in subjects with relapsed or refractory AML
Query!
Timepoint [67]
0
0
Up to 6 months
Query!
Primary outcome [68]
0
0
AML Part 5 Incidence of clinically significant changes in ECGs
Query!
Assessment method [68]
0
0
Evaluate the safety and tolerability of AMG 176 in combination with azacitidine in subjects with relapsed or refractory AML
Query!
Timepoint [68]
0
0
Up to 6 months
Query!
Primary outcome [69]
0
0
AML Part 5 Incidence of clinically significant changes in clinical laboratory tests
Query!
Assessment method [69]
0
0
Evaluate the safety and tolerability of AMG 176 in combination with azacitidine in subjects with relapsed or refractory AML
Query!
Timepoint [69]
0
0
Up to 6 months
Query!
Primary outcome [70]
0
0
AML Part 5 Pharmacokinetic parameters for AMG 176 and azacitidine: Cmax
Query!
Assessment method [70]
0
0
Evaluate the PK of AMG 176 and azacitidine when administered in combination
Query!
Timepoint [70]
0
0
1 month on treatment
Query!
Primary outcome [71]
0
0
AML Part 5 Pharmacokinetic parameters for AMG 176 and azacitidine: AUC
Query!
Assessment method [71]
0
0
Evaluate the PK of AMG 176 and azacitidine when administered in combination
Query!
Timepoint [71]
0
0
1 month on treatment
Query!
Primary outcome [72]
0
0
AML Part 5 Pharmacokinetic parameters for AMG 176 and azacitidine: CL
Query!
Assessment method [72]
0
0
Evaluate the PK of AMG 176 and azacitidine when administered in combination
Query!
Timepoint [72]
0
0
1 month on treatment
Query!
Primary outcome [73]
0
0
AML Part 5 Pharmacokinetic parameters for AMG 176 and azacitidine: t1/2
Query!
Assessment method [73]
0
0
Evaluate the PK of AMG 176 and azacitidine when administered in combination
Query!
Timepoint [73]
0
0
1 month on treatment
Query!
Secondary outcome [1]
0
0
MM Part 1a Overall response (OR) according to International Myeloma Working Group uniform response criteria (IMWG-URC) for MM subjects
Query!
Assessment method [1]
0
0
Evaluate preliminary efficacy of AMG 176 QD2 when given as monotherapy in relapsed or refractory MM
Query!
Timepoint [1]
0
0
6 months on treatment
Query!
Secondary outcome [2]
0
0
MM Part 1a Progression-free survival (PFS)
Query!
Assessment method [2]
0
0
Evaluate preliminary efficacy of AMG 176 QD2 when given as monotherapy in relapsed or refractory MM
Query!
Timepoint [2]
0
0
6 months on treatment
Query!
Secondary outcome [3]
0
0
MM Part 1a Time to response
Query!
Assessment method [3]
0
0
Evaluate preliminary efficacy of AMG 176 QD2 when given as monotherapy in relapsed or refractory MM
Query!
Timepoint [3]
0
0
6 months on treatment
Query!
Secondary outcome [4]
0
0
MM Part 1a Duration of response (DOR)
Query!
Assessment method [4]
0
0
Evaluate preliminary efficacy of AMG 176 QD2 when given as monotherapy in relapsed or refractory MM
Query!
Timepoint [4]
0
0
6 months on treatment
Query!
Secondary outcome [5]
0
0
MM Part 1a BAX and caspase 3 expression in circulating monocytes and /or circulating monocyte counts
Query!
Assessment method [5]
0
0
Demonstrate inactivation of myeloid cell leukemia sequence 1 (MCL1) by the increase of active Bcl 2 associated X protein (BAX) and caspase 3 in circulating monocytes and/or the decrease of circulating monocytes in AMG 176 QD2 treated subjects
Query!
Timepoint [5]
0
0
6 months on treatment
Query!
Secondary outcome [6]
0
0
MM Part 1b BAX and caspase 3 expression in circulating monocytes and/or circulating monocyte counts
Query!
Assessment method [6]
0
0
Demonstrate inactivation of MCL1 by the increase of active BAX and caspase 3 in circulating monocytes and /or the decrease of circulating monocytes in AMG 176 QW treated subjects
Query!
Timepoint [6]
0
0
6 months on treatment
Query!
Secondary outcome [7]
0
0
MM Part 1b Overall response (OR) according to IMWG-URC for MM subjects
Query!
Assessment method [7]
0
0
Evaluate preliminary efficacy of AMG 176 QW when given as monotherapy in relapsed or refractory MM
Query!
Timepoint [7]
0
0
6 months on treatment
Query!
Secondary outcome [8]
0
0
MM Part 1b Progression free survival (PFS)
Query!
Assessment method [8]
0
0
Evaluate preliminary efficacy of AMG 176 QW when given as monotherapy in relapsed or refractory MM
Query!
Timepoint [8]
0
0
6 months on treatment
Query!
Secondary outcome [9]
0
0
MM Part 1b Time to response
Query!
Assessment method [9]
0
0
Evaluate preliminary efficacy of AMG 176 QW when given as monotherapy in relapsed or refractory MM
Query!
Timepoint [9]
0
0
6 months on treatment
Query!
Secondary outcome [10]
0
0
MM Part 1b Duration of response (DOR)
Query!
Assessment method [10]
0
0
Evaluate preliminary efficacy of AMG 176 QW when given as monotherapy in relapsed or refractory MM
Query!
Timepoint [10]
0
0
6 months on treatment
Query!
Secondary outcome [11]
0
0
AML Part 3a, 3b and 3c Overall response (OR) according to the 2017 European Leukemia Net (ELN) criteria (Döhner et al, 2017)
Query!
Assessment method [11]
0
0
Evaluate preliminary efficacy of AMG 176 when given as monotherapy in relapsed or refractory AML
Query!
Timepoint [11]
0
0
6 months on treatment
Query!
Secondary outcome [12]
0
0
AML Part 3a, 3b and 3c Event free survival (EFS)
Query!
Assessment method [12]
0
0
Evaluate preliminary efficacy of AMG 176 when given as monotherapy in relapsed or refractory AML
Query!
Timepoint [12]
0
0
6 months on treatment
Query!
Secondary outcome [13]
0
0
AML Part 3a, 3b and 3c Time to response
Query!
Assessment method [13]
0
0
Evaluate preliminary efficacy of AMG 176 when given as monotherapy in relapsed or refractory AML
Query!
Timepoint [13]
0
0
6 months on treatment
Query!
Secondary outcome [14]
0
0
AML Part 3a, 3b and 3c Duration of response (DOR)
Query!
Assessment method [14]
0
0
Evaluate preliminary efficacy of AMG 176 when given as monotherapy in relapsed or refractory AML
Query!
Timepoint [14]
0
0
6 months on treatment
Query!
Secondary outcome [15]
0
0
AML Part 3d Incidence of treatment-emergent adverse events
Query!
Assessment method [15]
0
0
Evaluate the safety and tolerability of AMG 176 when given alone and in combination with itraconazole in subjects with AML
Query!
Timepoint [15]
0
0
3 weeks on treatment
Query!
Secondary outcome [16]
0
0
AML Part 3d Incidence of clinically significant changes in vital signs
Query!
Assessment method [16]
0
0
Evaluate the safety and tolerability of AMG 176 when given alone and in combination with itraconazole in subjects with AML
Query!
Timepoint [16]
0
0
3 weeks on treatment
Query!
Secondary outcome [17]
0
0
AML Part 3d Incidence of clinically significant changes in ECGs
Query!
Assessment method [17]
0
0
Evaluate the safety and tolerability of AMG 176 when given alone and in combination with itraconazole in subjects with AML
Query!
Timepoint [17]
0
0
3 weeks on treatment
Query!
Secondary outcome [18]
0
0
AML Part 3d Incidence of clinically significant changes in clinical laboratory tests
Query!
Assessment method [18]
0
0
Evaluate the safety and tolerability of AMG 176 when given alone and in combination with itraconazole in subjects with AML
Query!
Timepoint [18]
0
0
3 weeks on treatment
Query!
Secondary outcome [19]
0
0
AML Part 4 Overall response (OR) according to the 2017 ELN criteria in AML subjects
Query!
Assessment method [19]
0
0
Evaluate preliminary efficacy of AMG 176 when given in combination with azacitidine in relapsed or refractory AML
Query!
Timepoint [19]
0
0
6 months on treatment
Query!
Secondary outcome [20]
0
0
AML Part 4 Event free survival (EFS)
Query!
Assessment method [20]
0
0
Evaluate preliminary efficacy of AMG 176 when given in combination with azacitidine in relapsed or refractory AML
Query!
Timepoint [20]
0
0
6 months on treatment
Query!
Secondary outcome [21]
0
0
AML Part 4 Time to response
Query!
Assessment method [21]
0
0
Evaluate preliminary efficacy of AMG 176 when given in combination with azacitidine in relapsed or refractory AML
Query!
Timepoint [21]
0
0
6 months on treatment
Query!
Secondary outcome [22]
0
0
AML Part 4 Duration of response (DOR)
Query!
Assessment method [22]
0
0
Evaluate preliminary efficacy of AMG 176 when given in combination with azacitidine in relapsed or refractory AML
Query!
Timepoint [22]
0
0
6 months on treatment
Query!
Secondary outcome [23]
0
0
AML Part 5 OR according to the 2017 ELN criteria in AML subjects
Query!
Assessment method [23]
0
0
Evaluate preliminary efficacy of AMG 176 when given in combination with azacitidine in relapsed or refractory AML
Query!
Timepoint [23]
0
0
6 months on treatment
Query!
Secondary outcome [24]
0
0
AML Part 5 EFS
Query!
Assessment method [24]
0
0
Evaluate preliminary efficacy of AMG 176 when given in combination with azacitidine in relapsed or refractory AML
Query!
Timepoint [24]
0
0
6 months on treatment
Query!
Secondary outcome [25]
0
0
AML Part 5 Time to response
Query!
Assessment method [25]
0
0
Evaluate preliminary efficacy of AMG 176 when given in combination with azacitidine in relapsed or refractory AML
Query!
Timepoint [25]
0
0
6 months on treatment
Query!
Secondary outcome [26]
0
0
AML Part 5 DOR
Query!
Assessment method [26]
0
0
Evaluate preliminary efficacy of AMG 176 when given in combination with azacitidine in relapsed or refractory AML
Query!
Timepoint [26]
0
0
6 months on treatment
Query!
Eligibility
Key inclusion criteria
INCLUSION CRITERIA:
- For participants in Japan only: if a participant is younger than 20 years at the time
of signing the informed consent form, informed consent must be obtained from both the
participant and his/her legal representative
- (Multiple myeloma [MM] participants) Pathologically documented, multiple myeloma
relapsed or refractory disease after at least 2 lines of therapy
- (MM participants only) Measurable disease per the International Myeloma Working Group
response criteria
- (Acute myeloid leukemia [AML] participants) AML as defined by the World Health
Organization Classification persisting or recurring following one or more treatment
courses, and for participants in Japan, determined by the investigator to be not
eligible for approved anticancer drug therapy in Japan; EXCEPT acute promyelocytic
leukemia.
- (AML participants only) More than 5% blasts in bone marrow and Circulating white blood
cells < 25,000/ul.
- Must be willing and able to undergo a core bone marrow biopsy (MM participants only)
and bone marrow aspirate (MM and AML participants) at screening.
- Eastern Cooperative Oncology Group (ECOG) performance status of = 2,
- (MM partiicpants only) Satisfactory hematological function without transfusion or
growth factor support
- Life expectancy of > 3 months, in the opinion of the investigator
- Adequate hepatic function
- Adequate cardiac function
- Adequate renal function
- Female participants of childbearing potential must have a negative serum or urine
pregnancy test
- Other inclusion criteria may apply
EXCLUSION CRITERIA:
- Previously received an allogeneic stem cell transplant within 6 months OR having
received immunosuppressive therapy within the last three months OR having signs or
symptoms of acute or chronic graft-versus-host disease
- Autologous stem cell transplant less than 90 days prior to study day 1
- (MM participants only) MM with Immunoglobulin M subtype
- (MM participants only) Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal
protein, Skin changes syndrome
- (MM participants only) Existing plasma cell leukemia
- (MM participants only) Waldenstrom's macroglobulinemia
- (MM participants only) Amyloidosis
- Infection requiring intravenous anti-infective treatments within 1 week of study
enrollment (day 1)
- Myocardial infarction within 6 months of enrollment, symptomatic congestive heart
failure (New York Heart Association > class II)
- History of arterial thrombosis (eg, stroke or transient ischemic attack) in the past 6
months prior to enrollment
- Currently receiving treatment in another investigational device or drug study. Other
investigational procedures while participating in this study will be allowed if
approved by Amgen medical monitor
- Participants with elevated cardiac troponin above the manufacturer's 99th percentile
upper reference limit for ADVIA Centaur XP assay at screening performed by the central
laboratory
- Participants with evidence of recent cardiac injury at screening based on creatine
kinase-muscle/brain, N-terminal prohormone of brain natriuretic peptide, and
electrocardiogram
- Other exclusion criteria may apply
- (AML Part 3d only) History of QT prolongation, torsades de pointes, ventricular
tachycardia and cardiac arrest
- History or evidence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
infection unless agreed upon with medical monitor.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
85
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Non-randomised trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 1
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Active, not recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
13/06/2016
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
28/06/2024
Query!
Actual
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
142
Query!
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Query!
Recruitment hospital [1]
0
0
Royal North Shore Hospital - St Leonards
Query!
Recruitment hospital [2]
0
0
The Alfred Hospital - Melbourne
Query!
Recruitment hospital [3]
0
0
The Royal Melbourne Hospital - Parkville
Query!
Recruitment postcode(s) [1]
0
0
2065 - St Leonards
Query!
Recruitment postcode(s) [2]
0
0
3004 - Melbourne
Query!
Recruitment postcode(s) [3]
0
0
3050 - Parkville
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Colorado
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Georgia
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Illinois
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Louisiana
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Massachusetts
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
New Jersey
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Texas
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Utah
Query!
Country [10]
0
0
Canada
Query!
State/province [10]
0
0
Alberta
Query!
Country [11]
0
0
Canada
Query!
State/province [11]
0
0
Ontario
Query!
Country [12]
0
0
Germany
Query!
State/province [12]
0
0
Aachen
Query!
Country [13]
0
0
Germany
Query!
State/province [13]
0
0
Bonn
Query!
Country [14]
0
0
Germany
Query!
State/province [14]
0
0
Ulm
Query!
Country [15]
0
0
Germany
Query!
State/province [15]
0
0
Wuerzburg
Query!
Country [16]
0
0
Japan
Query!
State/province [16]
0
0
Aichi
Query!
Country [17]
0
0
Japan
Query!
State/province [17]
0
0
Chiba
Query!
Country [18]
0
0
Japan
Query!
State/province [18]
0
0
Fukuoka
Query!
Country [19]
0
0
Japan
Query!
State/province [19]
0
0
Okayama
Query!
Country [20]
0
0
Japan
Query!
State/province [20]
0
0
Tokyo
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Amgen
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
At least one dose level of AMG 176 will achieve acceptable safety and tolerability in
participants with relapsed or refractory multiple myeloma and participants with relapsed or
refractory acute myeloid leukemia
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT02675452
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
MD
Query!
Address
0
0
Amgen
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02675452
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