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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04178902
Registration number
NCT04178902
Ethics application status
Date submitted
25/11/2019
Date registered
26/11/2019
Titles & IDs
Public title
A Study of the Safety and Tolerability of ABBV-467 in Adult Participants With Relapsed/Refractory (R/R) Multiple Myeloma
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Scientific title
A First In Human Study of the MCL-1 Inhibitor, ABBV-467
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Secondary ID [1]
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2018-003744-24
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Secondary ID [2]
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M19-025
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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:
Multiple Myeloma (MM)
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Cancer
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Condition category
Condition code
Cancer
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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 - ABBV-467
Experimental: Part A: ABBV-467 Dose Escalation - ABBV-467 administered by intravenous (IV) infusion at various doses until a recommended phase 2 dose is determined.
Experimental: Part B: ABBV-467 Dose Expansion - ABBV-467 administered by intravenous (IV) infusion at recommended phase 2 dose as identified in Part A.
Treatment: Drugs: ABBV-467
Intravenous (IV) Infusion
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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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Number of Participants with Adverse Events
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Assessment method [1]
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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. The investigator will assess the relationship of each event to the use of study drug as being of reasonable possibility or no reasonable possibility. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug.
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Timepoint [1]
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Up to approximately 24 months after first dose of study drug
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Primary outcome [2]
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Change in Vital Signs
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Assessment method [2]
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Change in vital signs like systolic and diastolic blood pressure will be assessed.
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Timepoint [2]
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Baseline (Week 0) through approximately 24 months after first dose of study drug
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Primary outcome [3]
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Change in Electrocardiogram (ECG)
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Assessment method [3]
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12-lead resting ECGs will be recorded. Parameters include RR interval, PR interval, QT interval, and QRS duration.
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Timepoint [3]
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Baseline (Week 0) through approximately 24 months after first dose of study drug
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Primary outcome [4]
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Change in Cardiac Enzyme Levels
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Assessment method [4]
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Change in cardiac enzyme levels will be recorded.
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Timepoint [4]
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Baseline (Week 0) through approximately 24 months after first dose of study drug
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Primary outcome [5]
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Incidence of Abnormal Clinical Laboratory Test Results
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Assessment method [5]
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Number of participants with incidence of abnormal clinical laboratory test results like hematology will be assessed.
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Timepoint [5]
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Baseline (Week 0) through approximately 24 months after first dose of study drug
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Primary outcome [6]
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Maximum Observed Plasma Concentration (Cmax)
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Assessment method [6]
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Maximum Plasma Concentration (Cmax) of ABBV-467.
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Timepoint [6]
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Up to approximately Day 197
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Primary outcome [7]
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Terminal Phase Elimination Half-life (t1/2)
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Assessment method [7]
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Terminal phase elimination half-life (t1/2) of ABBV-467
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Timepoint [7]
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Up to approximately Day 197
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Primary outcome [8]
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Area Under the Plasma Concentration-Time Curve (AUCt)
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Assessment method [8]
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AUC from time 0 to time of last measurable concentration of ABBV-467.
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Timepoint [8]
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Up to approximately Day 197
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Primary outcome [9]
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Area Under the Plasma Concentration-Time Curve (AUC0-infinity)
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Assessment method [9]
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AUC from time 0 to infinity of ABBV-467.
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Timepoint [9]
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Up to approximately Day 197
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Primary outcome [10]
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Clearance of ABBV-467
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Assessment method [10]
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Clearance of ABBV-467.
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Timepoint [10]
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Up to approximately Day 197
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Secondary outcome [1]
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Overall Response Rate (ORR)
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Assessment method [1]
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ORR evaluated per adapted International Myeloma Working Group (IMWG) criteria and defined as partial response (PR) + very good partial response (VGPR) + complete remission (CR) + stringent complete response (sCR).
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Timepoint [1]
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Up to approximately 24 months after first dose of study drug
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Secondary outcome [2]
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Clinical Benefit Rate (CBR)
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Assessment method [2]
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CBR evaluated per adapted International Myeloma Working Group (IMWG) criteria and is defined as minimal response (MR) + PR + VGPR + CR + sCR.
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Timepoint [2]
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Up to approximately 24 months after first dose of study drug
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Secondary outcome [3]
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Duration of Response (DOR)
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Assessment method [3]
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DOR is defined as the time between date of first response and the first occurrence of progression or death from any cause, whichever comes first.
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Timepoint [3]
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Up to approximately 24 months after first dose of study drug
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Eligibility
Key inclusion criteria
* Documented diagnosis of multiple myeloma (MM).
* Measurable disease defined as at least 1 of the following:
* Serum monoclonal protein >= 1g/dL.
* Urine M-protein >= 200mg/24 hours.
* Serum immunoglobulin free light chain (FLC) >= 10 mg/dL (100 mg/L), provided serum FLC ratio is abnormal.
* Relapsed after or are refractory or intolerant to all established MM therapies that are both known to provide clinical benefit and locally available.
* Received at least 3 prior lines of therapy including 1 or more immunomodulatory agents, 1 or more proteasome inhibitors, and 1 or more anti-CD38 monoclonal antibodies.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
* Adequate hematologic, renal and hepatic function as described in the protocol.
* Echocardiogram with ejection fraction >= 50% and no other clinically significant findings that would increase the participant's susceptibility to cardiac toxicity.
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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
* Prior exposure to any targeted myeloid cell leukemia-1 (MCL-1) inhibitor.
* Antineoplastic therapy (including any cytotoxic, targeted and/or investigational therapy; but not including corticosteroids), within 28 days or 5 half-lives, whichever is shorter, prior to the first dose of study drug and through the last dose of study drug.
* Autologous stem cell transplant within 90 days prior to start of study drug.
* Allogenic stem cell transplant within 180 days prior to start of study drug.
* History of acute or chronic pancreatitis.
* Significant unresolved liver disease.
* History of hepatitis B or human immunodeficiency virus (HIV) infection.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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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
Stopped early
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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
19/05/2020
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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
16/04/2021
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Sample size
Target
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Accrual to date
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Final
8
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Recruitment in Australia
Recruitment state(s)
SA,VIC,WA
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Recruitment hospital [1]
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Royal Adelaide Hospital /ID# 223354 - Adelaide
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Recruitment hospital [2]
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St Vincent's Hospital Melbourne /ID# 222066 - Fitzroy
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Recruitment hospital [3]
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Alfred Health /ID# 214665 - Melbourne
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Recruitment hospital [4]
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Perth Blood Institute Ltd /ID# 226650 - Nedlands
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Recruitment hospital [5]
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Royal Perth Hospital /ID# 225498 - Perth
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Recruitment postcode(s) [1]
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5000 - Adelaide
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Recruitment postcode(s) [2]
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3065 - Fitzroy
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Recruitment postcode(s) [3]
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3004 - Melbourne
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Recruitment postcode(s) [4]
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6009 - Nedlands
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Recruitment postcode(s) [5]
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6000 - Perth
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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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Arizona
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United States of America
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State/province [2]
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California
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United States of America
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State/province [3]
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New Jersey
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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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Rhode Island
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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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South Carolina
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Country [6]
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France
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State/province [6]
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Pays-de-la-Loire
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Country [7]
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France
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State/province [7]
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Creteil
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Country [8]
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Israel
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State/province [8]
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Tel-Aviv
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Japan
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State/province [9]
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Aichi
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Japan
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Chiba
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Japan
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State/province [11]
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Fukuoka
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Country [12]
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Japan
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State/province [12]
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Tokyo
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Country [13]
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Spain
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State/province [13]
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Navarra, Comunidad
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Country [14]
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Spain
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State/province [14]
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Barcelona
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Spain
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State/province [15]
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Madrid
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Spain
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State/province [16]
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Malaga
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Taiwan
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State/province [17]
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Taipei
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Country [18]
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Taiwan
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State/province [18]
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Taichung City
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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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Ethics approval
Ethics application status
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Summary
Brief summary
This first-in-human study will evaluate the safety and tolerability of ABBV-467 in adult participants with relapsed/refractory multiple myeloma (MM).
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Trial website
https://clinicaltrials.gov/study/NCT04178902
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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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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04178902