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Trial record 14 of 67 for:    Venetoclax AND CRi

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

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ClinicalTrials.gov Identifier: NCT03484520
Recruitment Status : Recruiting
First Posted : March 30, 2018
Last Update Posted : November 20, 2019
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
AbbVie

Tracking Information
First Submitted Date  ICMJE March 26, 2018
First Posted Date  ICMJE March 30, 2018
Last Update Posted Date November 20, 2019
Actual Study Start Date  ICMJE July 23, 2018
Estimated Primary Completion Date January 21, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 26, 2018)
  • Tmax of Venetoclax [ Time Frame: Approximately 29 days after first dose of study drug ]
    Time to maximum plasma concentration (Tmax) of venetoclax.
  • 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.
  • Cmax of Venetoclax [ Time Frame: Approximately 29 days after first dose of study drug ]
    Maximum observed plasma concentration (Cmax) for Venetoclax.
  • 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)
  • 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.
  • Cmax of Dinaciclib [ Time Frame: Approximately 29 days after first dose of study drug ]
    Maximum plasma concentration (Cmax) of dinaciclib.
  • Half-life (t1/2) of Dinaciclib [ Time Frame: Approximately 29 days after first dose of study drug ]
    Half-life (t1/2) of dinaciclib.
  • 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.
  • 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.
  • Clearance of Dinaciclib [ Time Frame: Approximately 29 days after first dose of study drug ]
    Clearance (CL) of dinaciclib.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03484520 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 26, 2018)
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Venetoclax and Dinaciclib (MK7965) in Patients With Relapsed/Refractory Acute Myeloid Leukemia
Official Title  ICMJE Phase 1b Study of Venetoclax and Dinaciclib (MK7965) in Patients With Relapsed/Refractory Acute Myeloid Leukemia
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cancer - Acute Myeloid Leukemia
Intervention  ICMJE
  • Drug: Venetoclax
    tablet, oral
    Other Names:
    • ABT-199
    • GDC-0199
  • Drug: Dinaciclib
    intravenous
    Other Names:
    • MK-7965
    • SCH-727965
Study Arms  ICMJE Experimental: Venetoclax + Dinaciclib
Venetoclax and dinaciclib will be administered in combination. Different combinations of dose levels for venetoclax and dinaciclib will be explored.
Interventions:
  • Drug: Venetoclax
  • Drug: Dinaciclib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 26, 2018)
48
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 5, 2021
Estimated Primary Completion Date January 21, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com
Listed Location Countries  ICMJE Australia,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03484520
Other Study ID Numbers  ICMJE M16-183
2017-003213-26 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party AbbVie
Study Sponsor  ICMJE AbbVie
Collaborators  ICMJE Merck Sharp & Dohme Corp.
Investigators  ICMJE
Study Director: AbbVie Inc. AbbVie
PRS Account AbbVie
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP