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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
Scientific title
A First In Human Study of the MCL-1 Inhibitor, ABBV-467
Secondary ID [1] 0 0
2018-003744-24
Secondary ID [2] 0 0
M19-025
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Myeloma (MM) 0 0
Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants with Adverse Events
Timepoint [1] 0 0
Up to approximately 24 months after first dose of study drug
Primary outcome [2] 0 0
Change in Vital Signs
Timepoint [2] 0 0
Baseline (Week 0) through approximately 24 months after first dose of study drug
Primary outcome [3] 0 0
Change in Electrocardiogram (ECG)
Timepoint [3] 0 0
Baseline (Week 0) through approximately 24 months after first dose of study drug
Primary outcome [4] 0 0
Change in Cardiac Enzyme Levels
Timepoint [4] 0 0
Baseline (Week 0) through approximately 24 months after first dose of study drug
Primary outcome [5] 0 0
Incidence of Abnormal Clinical Laboratory Test Results
Timepoint [5] 0 0
Baseline (Week 0) through approximately 24 months after first dose of study drug
Primary outcome [6] 0 0
Maximum Observed Plasma Concentration (Cmax)
Timepoint [6] 0 0
Up to approximately Day 197
Primary outcome [7] 0 0
Terminal Phase Elimination Half-life (t1/2)
Timepoint [7] 0 0
Up to approximately Day 197
Primary outcome [8] 0 0
Area Under the Plasma Concentration-Time Curve (AUCt)
Timepoint [8] 0 0
Up to approximately Day 197
Primary outcome [9] 0 0
Area Under the Plasma Concentration-Time Curve (AUC0-infinity)
Timepoint [9] 0 0
Up to approximately Day 197
Primary outcome [10] 0 0
Clearance of ABBV-467
Timepoint [10] 0 0
Up to approximately Day 197
Secondary outcome [1] 0 0
Overall Response Rate (ORR)
Timepoint [1] 0 0
Up to approximately 24 months after first dose of study drug
Secondary outcome [2] 0 0
Clinical Benefit Rate (CBR)
Timepoint [2] 0 0
Up to approximately 24 months after first dose of study drug
Secondary outcome [3] 0 0
Duration of Response (DOR)
Timepoint [3] 0 0
Up to approximately 24 months after first dose of study drug

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/05/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
16/04/2021
Sample size
Target
Accrual to date
Final
8
Recruitment in Australia
Recruitment state(s)
SA,VIC,WA
Recruitment hospital [1] 0 0
Royal Adelaide Hospital /ID# 223354 - Adelaide
Recruitment hospital [2] 0 0
St Vincent's Hospital Melbourne /ID# 222066 - Fitzroy
Recruitment hospital [3] 0 0
Alfred Health /ID# 214665 - Melbourne
Recruitment hospital [4] 0 0
Perth Blood Institute Ltd /ID# 226650 - Nedlands
Recruitment hospital [5] 0 0
Royal Perth Hospital /ID# 225498 - Perth
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
3065 - Fitzroy
Recruitment postcode(s) [3] 0 0
3004 - Melbourne
Recruitment postcode(s) [4] 0 0
6009 - Nedlands
Recruitment postcode(s) [5] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
New Jersey
Country [4] 0 0
United States of America
State/province [4] 0 0
Rhode Island
Country [5] 0 0
United States of America
State/province [5] 0 0
South Carolina
Country [6] 0 0
France
State/province [6] 0 0
Pays-de-la-Loire
Country [7] 0 0
France
State/province [7] 0 0
Creteil
Country [8] 0 0
Israel
State/province [8] 0 0
Tel-Aviv
Country [9] 0 0
Japan
State/province [9] 0 0
Aichi
Country [10] 0 0
Japan
State/province [10] 0 0
Chiba
Country [11] 0 0
Japan
State/province [11] 0 0
Fukuoka
Country [12] 0 0
Japan
State/province [12] 0 0
Tokyo
Country [13] 0 0
Spain
State/province [13] 0 0
Navarra, Comunidad
Country [14] 0 0
Spain
State/province [14] 0 0
Barcelona
Country [15] 0 0
Spain
State/province [15] 0 0
Madrid
Country [16] 0 0
Spain
State/province [16] 0 0
Malaga
Country [17] 0 0
Taiwan
State/province [17] 0 0
Taipei
Country [18] 0 0
Taiwan
State/province [18] 0 0
Taichung City

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AbbVie
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ABBVIE INC.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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