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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Scientific title
Phase 1b Study of Venetoclax and AMG 176 in Patients With Relapsed/Refractory Hematologic Malignancies
Secondary ID [1] 0 0
2018-003314-41
Secondary ID [2] 0 0
M16-785
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Myeloid Leukemia 0 0
Non-Hodgkin's Lymphoma 0 0
Diffuse Large B-cell Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma

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

Outcomes
Primary outcome [1] 0 0
Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RPTD) for Venetoclax + AMG 176
Timepoint [1] 0 0
Up to 28 days after first dose of study drug in a dose-escalation phase
Primary outcome [2] 0 0
Number of Participants With Adverse Events
Timepoint [2] 0 0
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).
Secondary outcome [1] 0 0
Composite Complete Remission Rate (CRc) for Participants with AML
Timepoint [1] 0 0
Up to approximately 2 years from last subject first dose
Secondary outcome [2] 0 0
Objective Response Rate (ORR) for Participants with AML
Timepoint [2] 0 0
Up to approximately 2 years from last subject first dose
Secondary outcome [3] 0 0
ORR for Participants with NHL
Timepoint [3] 0 0
Up to approximately 2 years from last subject first dose
Secondary outcome [4] 0 0
Maximum Plasma Concentration (Cmax) of Venetoclax
Timepoint [4] 0 0
Up to approximately 28 days after first dose of study drug
Secondary outcome [5] 0 0
Time to Maximum Observed Plasma Concentration (Tmax) of Venetoclax
Timepoint [5] 0 0
Up to approximately 28 days after first dose of study drug
Secondary outcome [6] 0 0
AUC of Venetoclax
Timepoint [6] 0 0
Up to approximately 28 days after first dose of study drug
Secondary outcome [7] 0 0
Maximum Plasma Concentration (Cmax) of AMG 176
Timepoint [7] 0 0
Up to approximately 16 days after first dose of study drug
Secondary outcome [8] 0 0
Half-life (t1/2) of AMG 176
Timepoint [8] 0 0
Approximately 16 days after first dose of study drug
Secondary outcome [9] 0 0
AUC of AMG 176
Timepoint [9] 0 0
Approximately 16 days after first dose of study drug
Secondary outcome [10] 0 0
Clearance (CL) of AMG 176
Timepoint [10] 0 0
Approximately 16 days after first dose of study drug

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

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
18/03/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/12/2019
Sample size
Target
Accrual to date
Final
9
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Calvary Mater Newcastle /ID# 211455 - Waratah
Recruitment hospital [2] 0 0
Royal Adelaide Hospital /ID# 210602 - Adelaide
Recruitment hospital [3] 0 0
Alfred Health /ID# 210350 - Melbourne
Recruitment postcode(s) [1] 0 0
2298 - Waratah
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Iowa
Country [3] 0 0
United States of America
State/province [3] 0 0
Kansas
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
Missouri
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
North Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
Pennsylvania
Country [9] 0 0
Germany
State/province [9] 0 0
Hessen
Country [10] 0 0
Germany
State/province [10] 0 0
Sachsen
Country [11] 0 0
Germany
State/province [11] 0 0
Berlin
Country [12] 0 0
Germany
State/province [12] 0 0
Dresden
Country [13] 0 0
Germany
State/province [13] 0 0
Hamburg

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AbbVie
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Genentech, Inc.
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/industry
Name [2] 0 0
Amgen
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT03797261
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03797261