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A Study to Assess Safety and Efficacy of Venetoclax in Combination With Gilteritinib in Subjects With Relapsed/Refractory Acute Myeloid Leukemia

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ClinicalTrials.gov Identifier: NCT03625505
Recruitment Status : Recruiting
First Posted : August 10, 2018
Last Update Posted : April 16, 2019
Sponsor:
Collaborators:
Astellas Pharma Inc
Genentech, Inc.
Information provided by (Responsible Party):
AbbVie

Tracking Information
First Submitted Date  ICMJE August 8, 2018
First Posted Date  ICMJE August 10, 2018
Last Update Posted Date April 16, 2019
Actual Study Start Date  ICMJE October 18, 2018
Estimated Primary Completion Date January 9, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 8, 2018)
  • Recommended Phase 2 Dose (RPTD) of co-administered Study Drugs [ Time Frame: Up to approximately 6 months after the last subject is enrolled ]
    The RPTD of co-administered venetoclax and gilteritinib will be determined during the dose escalation phase of the study. RPTD will be determined using available safety and pharmacokinetics data.
  • Composite Complete Remission (CRc) Rate [ Time Frame: Up to approximately 6 months after the last subject is enrolled ]
    CRc rate is defined as the proportion of participants with documented complete response (CR) + CR with incomplete platelet recovery (CRp) + CR with incomplete blood count recovery (CRi) based on guidelines adapted from the International Working Group (IWG) for Acute Myeloid Leukemia (AML).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03625505 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 21, 2018)
  • Pharmacokinetics - Cmax [ Time Frame: Approximately 16 days after first dose of study drug ]
    Maximum observed plasma concentration (Cmax) of study drug.
  • Pharmacokinetics - Tmax [ Time Frame: Approximately 16 days after first dose of study drug ]
    Time to maximum plasma concentration (Tmax) of study drug.
  • Pharmacokinetics - AUCt [ Time Frame: Approximately 16 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) of study drug.
  • Pharmacokinetics - AUC0-24 Post-dose of study drug [ Time Frame: Approximately 16 days after first dose of study drug ]
    Area under the plasma concentration-time curve from 0 to 24 hours (AUC24) post-dose of study drug.
  • Duration of Response (DOR) of Composite Complete Remission (CRc) [ Time Frame: Up to approximately 6 months after the last subject is enrolled ]
    DOR of CRc will be defined as time from the first date achieving CRc to disease progression (including morphologic relapse) or death from any cause whichever is earlier.
  • Duration of Complete Remission (CR) + Complete Remission with incomplete hematologic recovery (CRh) [ Time Frame: Up to approximately 6 months after the last subject is enrolled ]
    DOR of CR + CRh will be defined as time from the first date achieving CR and/or CRh to disease progression (including morphologic relapse) or death from any cause whichever is earlier.
  • Complete Remission (CR) + with incomplete hematologic recovery (CRh) [ Time Frame: Up to approximately 6 months after the last subject is enrolled ]
    It is defined as the proportion of participants achieving CR or CRh based on guidelines adapted from the International Working Group (IWG) for Acute Myeloid Leukemia (AML).
Original Secondary Outcome Measures  ICMJE
 (submitted: August 8, 2018)
  • Pharmacokinetics - Cmax [ Time Frame: Approximately 16 days after first dose of study drug ]
    Maximum observed plasma concentration (Cmax) of study drug.
  • Pharmacokinetics - Tmax [ Time Frame: Approximately 16 days after first dose of study drug ]
    Time to maximum plasma concentration (Tmax) of study drug.
  • Pharmacokinetics - AUCt [ Time Frame: Approximately 16 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) of study drug.
  • Pharmacokinetics - AUC0-24 Post-dose of study drug [ Time Frame: Approximately 16 days after first dose of study drug ]
    Area under the plasma concentration-time curve from 0 to 24 hours (AUC24) post-dose of study drug.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Assess Safety and Efficacy of Venetoclax in Combination With Gilteritinib in Subjects With Relapsed/Refractory Acute Myeloid Leukemia
Official Title  ICMJE A Multicenter, Open-Label Phase 1b Study to Assess Safety and Efficacy of Venetoclax in Combination With Gilteritinib in Subjects With Relapsed/Refractory Acute Myeloid Leukemia
Brief Summary A dose-escalation study evaluating the safety, tolerability, pharmacokinetics (PK) and efficacy of venetoclax, in combination with gilteritinib, in subjects with relapsed or refractory (R/R) acute myeloid leukemia (AML) who have failed to respond to, and/or have relapsed or progressed after at least 1 prior therapy.
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 Acute Myeloid Leukemia (AML)
Intervention  ICMJE
  • Drug: Venetoclax
    tablet, oral
    Other Names:
    • ABT-199
    • GDC-0199
  • Drug: Gilteritinib
    tablet, oral
    Other Name: ASP-2215
Study Arms  ICMJE Experimental: Venetoclax + Gilteritinib
Venetoclax and gilteritinib will be administered in combination. Different combinations of dose levels for venetoclax and gilteritinib will be explored.
Interventions:
  • Drug: Venetoclax
  • Drug: Gilteritinib
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: August 8, 2018)
52
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 14, 2021
Estimated Primary Completion Date January 9, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subject should have an established, confirmed diagnosis of Acute Myeloid Leukemia (AML) by World Health Organization (2016).
  • Subject should have failed at least 1 line of prior therapy (defined as failure to respond to therapy, and/or progression during or after therapy).
  • Subject should have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
  • Subject should have adequate hematologic, kidney and liver function as described in the protocol.
  • For subjects enrolling into the Expansion Cohort only: a documented FMS-like Tyrosine Kinase (FLT3) mutation in bone marrow or peripheral blood, as described in the protocol.

Exclusion Criteria:

  • Subject has a diagnosis of acute promyelocytic leukemia (APL) or BCR-ABL-positive leukemia.
  • Subject has a history of other malignancies within 2 years prior to study entry, with exceptions as described in the protocol.
  • Subject has active central nervous system leukemia.
  • Subject has a history of chronic New York Heart Association (NYHA) class IV heart failure.
  • Subject has a corrected QT interval of > 450 ms.
  • Subject has a chronic respiratory disease that requires continuous oxygen use.
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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03625505
Other Study ID Numbers  ICMJE M16-802
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
  • Astellas Pharma Inc
  • Genentech, Inc.
Investigators  ICMJE
Study Director: AbbVie Inc. AbbVie
PRS Account AbbVie
Verification Date April 2019

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