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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03484520




Registration number
NCT03484520
Ethics application status
Date submitted
26/03/2018
Date registered
26/03/2018
Date last updated
18/12/2018

Titles & IDs
Public title
A Study of Venetoclax and Dinaciclib (MK7965) in Patients With Relapsed/Refractory Acute Myeloid Leukemia
Scientific title
Phase 1b Study of Venetoclax and Dinaciclib (MK7965) in Patients With Relapsed/Refractory Acute Myeloid Leukemia
Secondary ID [1] 0 0
M16-183
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer - Acute Myeloid Leukemia (AML) 0 0
Condition category
Condition code
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 - Dinaciclib

Experimental: Venetoclax + Dinaciclib - Venetoclax and dinaciclib will be administered in combination. Different combinations of dose levels for venetoclax and dinaciclib will be explored.


Treatment: Drugs: Venetoclax
tablet, oral

Treatment: Drugs: Dinaciclib
intravenous

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Tmax of Venetoclax - Time to maximum plasma concentration (Tmax) of venetoclax.
Timepoint [1] 0 0
Approximately 29 days after first dose of study drug
Primary outcome [2] 0 0
Recommended Phase 2 Dose (RPTD) of co-administered Dinaciclib and Venetoclax - Tthe RPTD of co-administered venetoclax and dinaciclib will be determined during the dose escalation phase of the study. RPTD will be determined using available safety and pharmacokinetics data.
Timepoint [2] 0 0
Minimum first cycle of dosing (21 days)
Primary outcome [3] 0 0
Cmax of Venetoclax - Maximum observed plasma concentration (Cmax) for Venetoclax.
Timepoint [3] 0 0
Approximately 29 days after first dose of study drug
Primary outcome [4] 0 0
AUCt of Venetoclax - Area Under the Plasma Concentration-time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUCt)
Timepoint [4] 0 0
Approximately 29 days after first dose of study drug
Primary outcome [5] 0 0
AUC0-24 Post-dose of Venetoclax - Area under the plasma concentration-time curve from 0 to 24 hours (AUC24) post-dose of venetoclax.
Timepoint [5] 0 0
Approximately 29 days after first dose of study drug
Primary outcome [6] 0 0
Cmax of Dinaciclib - Maximum plasma concentration (Cmax) of dinaciclib.
Timepoint [6] 0 0
Approximately 29 days after first dose of study drug
Primary outcome [7] 0 0
Half-life (t1/2) of Dinaciclib - Half-life (t1/2) of dinaciclib.
Timepoint [7] 0 0
Approximately 29 days after first dose of study drug
Primary outcome [8] 0 0
AUCt Post-dose of Dinaciclib - Area under the plasma concentration-time curve from time zero to time t (AUCt) post-dose dinaciclib.
Timepoint [8] 0 0
Approximately 29 days after first dose of study drug
Primary outcome [9] 0 0
AUC0-8 of Dinaciclib - Area under the plasma concentration-time curve from 0 to infinity (AUC0-8) post-dose of dinaciclib.
Timepoint [9] 0 0
Approximately 29 days after first dose of study drug
Primary outcome [10] 0 0
Clearance of Dinaciclib - Clearance (CL) of dinaciclib.
Timepoint [10] 0 0
Approximately 29 days after first dose of study drug
Secondary outcome [1] 0 0
Complete Response (CR) Rate - CR is defined as the proportion of participants with documented complete response (CR) based on International Working Group (IWG) criteria.
Timepoint [1] 0 0
Up to approximately 18 months
Secondary outcome [2] 0 0
Composite CR Rate (CR + CRi) - Composite is defined as CR + CRi (CR with incomplete blood count recovery) based on IWG criteria.
Timepoint [2] 0 0
Up to approximately 18 months
Secondary outcome [3] 0 0
Objective Response Rate (ORR) - ORR is defined as the proportion of participants with documented partial response (PR) or better (CR + CRi + partial response [PR]) based on IWG criteria.
Timepoint [3] 0 0
Up to approximately 18 months

Eligibility
Key inclusion criteria
- Diagnosis of acute myeloid leukemia (AML) by World Health Organization criteria
excluding acute promyelocytic leukemia (APL)-M3.

- Eastern Cooperative Oncology Group (ECOG) performance status = 2.

- Participant must have adequate hematologic, renal, and liver function laboratory
values as described in the protocol.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Known central nervous system leukemia

- Severe chronic obstructive pulmonary disease (COPD) with hypoxemia

- History of any malignancy within the last 6 months except for those specified in this
protocol and low-grade malignancies not requiring active treatment.

- Prior allogeneic stem cell transplant within 6 months of study drug administration and
no requirement for graft versus host therapy.

- History of clinically significant medical condition that, in the opinion of the
investigator, would adversely affect participation in this study.

- Known active infection with human immunodeficiency virus (HIV), hepatitis B, or
hepatitis C.

Study design
Purpose of the study
Treatment
Allocation to intervention
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
Single group
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,TAS,VIC
Recruitment hospital [1] 0 0
Gold Coast University Hospital /ID# 202759 - Southport
Recruitment hospital [2] 0 0
Royal Hobart Hospital /ID# 202763 - Hobart
Recruitment hospital [3] 0 0
Monash Medical Centre /ID# 202762 - Melbourne
Recruitment postcode(s) [1] 0 0
4215 - Southport
Recruitment postcode(s) [2] 0 0
7000 - Hobart
Recruitment postcode(s) [3] 0 0
3168 - Melbourne
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
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
North Carolina
Country [7] 0 0
United States of America
State/province [7] 0 0
Ohio
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
Spain
State/province [9] 0 0
Valenciana
Country [10] 0 0
Spain
State/province [10] 0 0
Madrid
Country [11] 0 0
Spain
State/province [11] 0 0
Salamanca

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
Merck Sharp & Dohme Corp.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
An open-label, dose-escalation study to assess safety, pharmacokinetics and efficacy as well
as determine the recommended Phase 2 doses of co-administered therapy of dinaciclib and
venetoclax for patients with relapsed or refractory Acute Myeloid Leukemia (R/R AML).
Trial website
https://clinicaltrials.gov/show/NCT03484520
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
ABBVIE CALL CENTER
Address 0 0
Country 0 0
Phone 0 0
847.283.8955
Fax 0 0
Email 0 0
abbvieclinicaltrials@abbvie.com
Contact person for scientific queries

No data has been provided for results reporting
Summary results
Not applicable