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A Study of Venetoclax and Dinaciclib (MK7965) in Patients With Relapsed/Refractory Acute Myeloid Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03484520
Recruitment Status : Terminated (Strategic considerations)
First Posted : March 30, 2018
Last Update Posted : December 30, 2022
Sponsor:
Collaborator:
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
AbbVie

Study Description
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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).

Condition or disease Intervention/treatment Phase
Cancer - Acute Myeloid Leukemia Drug: Venetoclax Drug: Dinaciclib Phase 1

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1b Study of Venetoclax and Dinaciclib (MK7965) in Patients With Relapsed/Refractory Acute Myeloid Leukemia
Actual Study Start Date : July 23, 2018
Actual Primary Completion Date : December 1, 2022
Actual Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Venetoclax

Arms and Interventions
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Arm Intervention/treatment
Experimental: Venetoclax + Dinaciclib
Venetoclax and dinaciclib will be administered in combination. Different combinations of dose levels for venetoclax and dinaciclib will be explored.
 Drug: Venetoclax
tablet, oral
Other Names:
  • ABT-199
  • GDC-0199

Drug: Dinaciclib
intravenous
Other Names:
  • MK-7965
  • SCH-727965


Outcome Measures
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Primary Outcome Measures :
  1. Tmax of Venetoclax [ Time Frame: Approximately 29 days after first dose of study drug ]
    Time to maximum plasma concentration (Tmax) of venetoclax.

  2. Recommended Phase 2 Dose (RPTD) of co-administered Dinaciclib and Venetoclax [ Time Frame: Minimum first cycle of dosing (21 days) ]
    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.

  3. Cmax of Venetoclax [ Time Frame: Approximately 29 days after first dose of study drug ]
    Maximum observed plasma concentration (Cmax) for Venetoclax.

  4. AUCt of Venetoclax [ Time Frame: Approximately 29 days after first dose of study drug ]
    Area Under the Plasma Concentration-time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUCt)

  5. AUC0-24 Post-dose of Venetoclax [ Time Frame: Approximately 29 days after first dose of study drug ]
    Area under the plasma concentration-time curve from 0 to 24 hours (AUC24) post-dose of venetoclax.

  6. Cmax of Dinaciclib [ Time Frame: Approximately 29 days after first dose of study drug ]
    Maximum plasma concentration (Cmax) of dinaciclib.

  7. Half-life (t1/2) of Dinaciclib [ Time Frame: Approximately 29 days after first dose of study drug ]
    Half-life (t1/2) of dinaciclib.

  8. AUCt Post-dose of Dinaciclib [ Time Frame: Approximately 29 days after first dose of study drug ]
    Area under the plasma concentration-time curve from time zero to time t (AUCt) post-dose dinaciclib.

  9. AUC0-∞ of Dinaciclib [ Time Frame: Approximately 29 days after first dose of study drug ]
    Area under the plasma concentration-time curve from 0 to infinity (AUC0-∞) post-dose of dinaciclib.

  10. Clearance of Dinaciclib [ Time Frame: Approximately 29 days after first dose of study drug ]
    Clearance (CL) of dinaciclib.


Secondary Outcome Measures :
  1. Complete Response (CR) Rate [ Time Frame: Up to approximately 18 months ]
    CR is defined as the proportion of participants with documented complete response (CR) based on International Working Group (IWG) criteria.

  2. Composite CR Rate (CR + CRi) [ Time Frame: Up to approximately 18 months ]
    Composite is defined as CR + CRi (CR with incomplete blood count recovery) based on IWG criteria.

  3. Objective Response Rate (ORR) [ Time Frame: Up to approximately 18 months ]
    ORR is defined as the proportion of participants with documented partial response (PR) or better (CR + CRi + partial response [PR]) based on IWG criteria.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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.
  • History of tumor lysis syndrome (TLS) due to previous exposure to venetoclax.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03484520


Locations
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United States, Arkansas
University of Arkansas /ID# 200016
Little Rock, Arkansas, United States, 72205
United States, California
David Geffen School of Medicin /ID# 200015
Los Angeles, California, United States, 90095
United States, Illinois
The University ofChicago /ID# 200017
Chicago, Illinois, United States, 60637
United States, Maryland
University of Maryland School of Medicine /ID# 204015
Baltimore, Maryland, United States, 21201-1544
United States, North Carolina
Wake Forest Baptist Medical Center /ID# 200288
Winston-Salem, North Carolina, United States, 27157-0001
United States, Ohio
The Ohio State University /ID# 200668
Columbus, Ohio, United States, 43210
United States, Texas
University of Texas MD Anderson Cancer Center /ID# 205215
Houston, Texas, United States, 77030
Australia, Queensland
Gold coast University Hospital /ID# 202759
SouthPort, Queensland, Australia, 4215
Australia, Tasmania
Royal Hobart Hospital /ID# 202763
Hobart, Tasmania, Australia, 7000
Australia, Victoria
Monash Medical Centre /ID# 202762
Melbourne, Victoria, Australia, 3168
Spain
Hospital Universitario Ramon y Cajal /ID# 201729
Madrid, Spain, 28034
Hospital Universitario de Salamanca /ID# 201728
Salamanca, Spain, 37711
Hospital Universitario y Politecnico La Fe /ID# 202318
Valencia, Spain, 46026
Sponsors and Collaborators
AbbVie
Merck Sharp & Dohme LLC
Investigators
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Study Director: ABBVIE INC. AbbVie
More Information
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03484520    
Other Study ID Numbers: M16-183
2017-003213-26 ( EudraCT Number )
First Posted: March 30, 2018    Key Record Dates
Last Update Posted: December 30, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by AbbVie:
Cancer, Acute Myeloid Leukemia (AML), venetoclax, dinaciclib, Relapsed/refractory AML, Pharmacokinetics, Venetoclax, Dinaciclib
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
 Neoplasms
Venetoclax
Antineoplastic Agents