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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/NCT03797261
Registration number
NCT03797261
Ethics application status
Date submitted
7/01/2019
Date registered
9/01/2019
Date last updated
7/12/2021
Titles & IDs
Public title
A Study of Venetoclax and AMG 176 in Patients With Relapsed/Refractory Hematologic Malignancies
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Scientific title
Phase 1b Study of Venetoclax and AMG 176 in Patients With Relapsed/Refractory Hematologic Malignancies
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Secondary ID [1]
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2018-003314-41
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Secondary ID [2]
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M16-785
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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:
Acute Myeloid Leukemia
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Non-Hodgkin's Lymphoma
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Diffuse Large B-cell Lymphoma
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Condition category
Condition code
Cancer
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Cancer
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Leukaemia - Acute leukaemia
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Cancer
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Leukaemia - Chronic leukaemia
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Cancer
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Children's - Leukaemia & Lymphoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Venetoclax
Treatment: Drugs - AMG 176
Experimental: Venetoclax + AMG 176 - Venetoclax and AMG 176 will be administered in combination. Different combinations of dose levels for venetoclax and AMG 176 will be explored.
Treatment: Drugs: Venetoclax
tablet, oral
Treatment: Drugs: AMG 176
solution, intravenous
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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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Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RPTD) for Venetoclax + AMG 176
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Assessment method [1]
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The MTD and/or RPTD of venetoclax and of AMG 176 will be determined during the dose escalation phase of the study.
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Timepoint [1]
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Up to 28 days after first dose of study drug in a dose-escalation phase
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Primary outcome [2]
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Number of Participants With Adverse Events
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Assessment method [2]
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An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
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Timepoint [2]
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From first dose of study drug until 30 days or 5 half-lives after discontinuation of study drug administration will be collected (up to approximately 4 years).
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Secondary outcome [1]
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Composite Complete Remission Rate (CRc) for Participants with AML
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Assessment method [1]
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CRc rate is defined as CR + CRi (CR with incomplete blood count recovery).
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Timepoint [1]
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Up to approximately 2 years from last subject first dose
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Secondary outcome [2]
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Objective Response Rate (ORR) for Participants with AML
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Assessment method [2]
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ORR is defined as the percentage of participants with documented partial response (PR) or better (CR + CRi + partial response [PR]) based on International Working Group (IWG) criteria for AML
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Timepoint [2]
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Up to approximately 2 years from last subject first dose
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Secondary outcome [3]
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ORR for Participants with NHL
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Assessment method [3]
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ORR is defined as the percentage of participants with documented CR + PR based on Lugano criteria for NHL.
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Timepoint [3]
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Up to approximately 2 years from last subject first dose
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Secondary outcome [4]
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Maximum Plasma Concentration (Cmax) of Venetoclax
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Assessment method [4]
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Maximum observed plasma concentration (Cmax) of venetoclax.
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Timepoint [4]
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Up to approximately 28 days after first dose of study drug
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Secondary outcome [5]
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Time to Maximum Observed Plasma Concentration (Tmax) of Venetoclax
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Assessment method [5]
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Time to maximum plasma concentration (Tmax) of Venetoclax.
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Timepoint [5]
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Up to approximately 28 days after first dose of study drug
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Secondary outcome [6]
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AUC of Venetoclax
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Assessment method [6]
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Area under the plasma concentration-time curve (AUC) of venetoclax.
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Timepoint [6]
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Up to approximately 28 days after first dose of study drug
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Secondary outcome [7]
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Maximum Plasma Concentration (Cmax) of AMG 176
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Assessment method [7]
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Maximum observed plasma concentration (Cmax) of AMG 176
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Timepoint [7]
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Up to approximately 16 days after first dose of study drug
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Secondary outcome [8]
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Half-life (t1/2) of AMG 176
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Assessment method [8]
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Terminal phase elimination half-life (t1/2)
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Timepoint [8]
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Approximately 16 days after first dose of study drug
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Secondary outcome [9]
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AUC of AMG 176
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Assessment method [9]
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Area Under the Plasma Concentration-time Curve (AUC) of AMG 176
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Timepoint [9]
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Approximately 16 days after first dose of study drug
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Secondary outcome [10]
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Clearance (CL) of AMG 176
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Assessment method [10]
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Clearance (CL) is defined the volume of plasma cleared of the drug per unit time.
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Timepoint [10]
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Approximately 16 days after first dose of study drug
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Eligibility
Key inclusion criteria
- Adequate kidney, liver and hematology values as described in the protocol.
- Diagnosis of relapsed or refractory (R/R) acute myeloid leukemia (AML) or R/R
Non-Hodgkin's lymphoma (NHL)/diffuse large B-cell lymphoma (DLBCL) confirmed by the
World Health Organization (WHO) criteria, as appropriate.
- Meets the following disease activity criteria:
- AML: must have received at least 1 prior therapy for AML and be ineligible for
cytotoxic therapy and allogeneic stem cell transplant.
- NHL/DLBCL: measurable disease with a bidimensional lesion measuring at least 1.5 cm;
received at least 1 prior therapy for NHL with no curative treatment option as
determined by the investigator and be ineligible for a stem cell transplant.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- History of clinically significant medical condition that, in the opinion of the
investigator, would adversely affect participation in this study.
- History of of any malignancy within the last 6 months except for those specified in
this protocol and low-grade malignancies not requiring active treatment such as
non-melanoma skin cancer, cervical intraepithelial neoplasia, or prostate cancer in
situ.
- Prior allogeneic stem cell transplant or autologous stem cell transplant within 100
days of study drug administration and no signs or symptoms of acute or chronic
graft-versus-host disease.
- Previous enrollment in a randomized trial including either venetoclax or AMG 176.
- Known active or chronic pancreatitis; severe chronic obstructive pulmonary disease
with hypoxemia; central nervous system manifestations of malignancy.
- Active, uncontrolled infection.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
18/03/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
30/12/2019
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Sample size
Target
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Accrual to date
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Final
9
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
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Recruitment hospital [1]
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Calvary Mater Newcastle /ID# 211455 - Waratah
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Recruitment hospital [2]
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Royal Adelaide Hospital /ID# 210602 - Adelaide
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Recruitment hospital [3]
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Alfred Health /ID# 210350 - Melbourne
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Recruitment postcode(s) [1]
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2298 - Waratah
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Recruitment postcode(s) [2]
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5000 - Adelaide
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Recruitment postcode(s) [3]
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3004 - Melbourne
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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State/province [2]
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Iowa
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Country [3]
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United States of America
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State/province [3]
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Kansas
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Country [4]
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United States of America
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State/province [4]
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Massachusetts
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Country [5]
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United States of America
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State/province [5]
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Missouri
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Country [6]
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United States of America
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State/province [6]
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New York
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Country [7]
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United States of America
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State/province [7]
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North Carolina
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Country [8]
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United States of America
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State/province [8]
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Pennsylvania
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Country [9]
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Germany
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State/province [9]
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Hessen
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Country [10]
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Germany
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State/province [10]
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Sachsen
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Country [11]
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Germany
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State/province [11]
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Berlin
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Country [12]
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Germany
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State/province [12]
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Dresden
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Country [13]
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Germany
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State/province [13]
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Hamburg
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
AbbVie
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Address
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Country
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Genentech, Inc.
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Address [1]
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Country [1]
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Other collaborator category [2]
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Commercial sector/Industry
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Name [2]
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Amgen
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Address [2]
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Country [2]
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Ethics approval
Ethics application status
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Summary
Brief summary
This dose-escalation study evaluating the safety, pharmacokinetics and preliminary efficacy
of venetoclax in combination with AMG 176 in participants with relapsed or refractory acute
myeloid leukemia (AML) and participants with Non-Hodgkin's lymphoma (NHL)/diffuse large
B-cell lymphoma (DLBCL).
This study will include a dose escalation phase to identify the maximum tolerated
dose/recommended phase 2 dose (MTD/RPTD) of venetoclax plus AMG 176 as well as a dose
expansion phase to confirm safety, explore efficacy, and confirm the suitability of the
preliminary RPTD.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03797261
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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ABBVIE INC.
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Address
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AbbVie
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03797261
Download to PDF