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Trial record 9 of 198 for:    Venetoclax

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 : June 7, 2019
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
AbbVie

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
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
Estimated Primary Completion Date : January 21, 2020
Estimated Study Completion Date : October 5, 2021


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




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.



Information from the National Library of Medicine

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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.

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


Contacts
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Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com

Locations
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United States, Arkansas
University of Arkansas /ID# 200016 Not yet recruiting
Little Rock, Arkansas, United States, 72205
United States, California
David Geffen School of Medicin /ID# 200015 Recruiting
Los Angeles, California, United States, 90095
Cedars-Sinai Medical Center - West Hollywood /ID# 202245 Not yet recruiting
West Hollywood, California, United States, 90048
United States, Illinois
The University of Chicago /ID# 200017 Recruiting
Chicago, Illinois, United States, 60637
United States, Maryland
Univ Maryland School Medicine /ID# 204015 Recruiting
Baltimore, Maryland, United States, 21201
United States, North Carolina
Wake Forest Baptist Medical Center /ID# 200288 Recruiting
Winston-Salem, North Carolina, United States, 27157-0001
United States, Ohio
The Ohio State University - Columbus /ID# 200668 Recruiting
Columbus, Ohio, United States, 43210
United States, Texas
Univ TX, MD Anderson /ID# 205215 Not yet recruiting
Houston, Texas, United States, 77030
Australia, Queensland
Gold Coast University Hospital /ID# 202759 Recruiting
Southport, Queensland, Australia, 4215
Australia, Tasmania
Royal Hobart Hospital /ID# 202763 Recruiting
Hobart, Tasmania, Australia, 7000
Australia, Victoria
Monash Medical Centre /ID# 202762 Recruiting
Melbourne, Victoria, Australia, 3168
Spain
Hospital Universitario y Politecnico La Fe /ID# 202318 Recruiting
Valencia, Valenciana, Spain, 46026
Hospital Ramon y Cajal /ID# 201729 Recruiting
Madrid, Spain, 28036
Hospital Clinico Univ de Salamanca /ID# 201728 Recruiting
Salamanca, Spain, 37007
Sponsors and Collaborators
AbbVie
Merck Sharp & Dohme Corp.
Investigators
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Study Director: AbbVie Inc. AbbVie

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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03484520     History of Changes
Other Study ID Numbers: M16-183
First Posted: March 30, 2018    Key Record Dates
Last Update Posted: June 7, 2019
Last Verified: June 2019
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