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Trial record 23 of 182 for:    Venetoclax

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

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.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia (AML) Drug: Venetoclax Drug: Gilteritinib Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : October 18, 2018
Estimated Primary Completion Date : January 9, 2021
Estimated Study Completion Date : October 14, 2021


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

Drug: Gilteritinib
tablet, oral
Other Name: ASP-2215




Primary Outcome Measures :
  1. 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.

  2. 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).


Secondary Outcome Measures :
  1. Pharmacokinetics - Cmax [ Time Frame: Approximately 16 days after first dose of study drug ]
    Maximum observed plasma concentration (Cmax) of study drug.

  2. Pharmacokinetics - Tmax [ Time Frame: Approximately 16 days after first dose of study drug ]
    Time to maximum plasma concentration (Tmax) of study drug.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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).



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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:

  • 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.

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): NCT03625505


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

Locations
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United States, California
David Geffen School of Medicin /ID# 200166 Not yet recruiting
Los Angeles, California, United States, 90095
UC San Francisco Medical Center-Parnassus /ID# 200205 Recruiting
San Francisco, California, United States, 94143-2202
United States, Florida
Sylvester Comprehensive Cancer /ID# 200268 Recruiting
Miami, Florida, United States, 33136-1002
United States, Illinois
Northwestern Memorial Hospital /ID# 200230 Recruiting
Chicago, Illinois, United States, 60611-2927
United States, Kentucky
Norton Cancer Institute /ID# 200623 Recruiting
Louisville, Kentucky, United States, 40202-3700
United States, Maryland
Johns Hopkins University /ID# 200349 Recruiting
Baltimore, Maryland, United States, 21287
United States, Minnesota
Mayo Clinic - Rochester /ID# 200346 Not yet recruiting
Rochester, Minnesota, United States, 55905-0001
United States, New Jersey
Hackensack Univ Med Ctr /ID# 200229 Recruiting
Hackensack, New Jersey, United States, 07601
United States, New York
Weill Cornell Medical College /ID# 200109 Not yet recruiting
New York, New York, United States, 10021
United States, Pennsylvania
Hosp of the Univ of Penn /ID# 200348 Recruiting
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
MD Anderson Cancer Center /ID# 206686 Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
AbbVie
Astellas Pharma Inc
Genentech, Inc.
Investigators
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Study Director: AbbVie Inc. AbbVie

Additional Information:
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03625505     History of Changes
Other Study ID Numbers: M16-802
First Posted: August 10, 2018    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 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)
Relapsed or Refractory AML
Pharmacokinetics
venetoclax
gilteritinib

Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Venetoclax
Antineoplastic Agents