A Study Evaluating Venetoclax Alone and in Combination With Azacitidine in Subjects With Higher-Risk Myelodysplastic Syndromes (MDS) After Hypomethylating Agent-Failure

Description

This is a Phase 1b, dose-ranging, open-label, multicenter study designed to evaluate the safety and pharmacokinetics of venetoclax as a single-agent and in combination with azacitidine in participants with higher-risk Myelodysplastic Syndromes (MDS) after Hypomethylating Agent (HMA)-Failure.

Study Start Date

March, 22 2017

Estimated Completion Date

August 2020

Interventions

  • Drug: azacitidine
  • Drug: venetoclax

Study ID

AbbVie -- M15-522

Status

Recruiting

Trial ID

NCT02966782

Study Type

Interventional

Trial Phase

Phase 1

Enrollment Quota

68

Sponsor

AbbVie

Inclusion Criteria

  • Subject must have failure of prior therapy with HMA for HR MDS as first-line MDS treatment with HMA-failure being defined as i) Relapse after initial complete or partial response or hematological improvement after at least 6 cycles of azacitidine or at least 4 cycles of decitabine within the last 2 years or ii) Failure to achieve complete or partial response or hematological improvement after at least 6 cycles of azacitidine or at least 4 cycles of decitabine within the last 2 years. Note: High-Risk MDS is defined as comprising International Prognostic Scoring System (IPSS) risk categories Int-2 or High (IPSS overall score ? 1.5)
  • Subjects must have presence of ? 5% and < 20% bone marrow blasts per bone marrow biopsy/aspirate at screening.
  • Subject must have an Eastern Cooperative Oncology Group (ECOG) performance score of ?2.
  • Participant must have adequate hematologic, renal, and hepatic function.

Exclusion Criteria

  • Subject has received more than 1 prior therapy for MDS. Note: Prior supportive care in form in of transfusions or growth factors, etc., is not considered prior therapy. Supportive care should be discontinued ? 14 days prior to the first dose of study drug. Subjects may continue oral corticosteroids for management of conditions other than MDS (e.g., asthma, rheumatoid arthritis) at a stable daily dose equivalent to ? 10 mg prednisone during screening and study participation.
  • Subject had received prior HMA therapy with HMAs for lower-risk MDS with IPSS risk categories Low or Int-1 (overall IPSS score < 1.5).
  • Subject has received therapy other than azacitidine or decitabine for the treatment of MDS.
  • Subject has received prior therapy with a BH3 mimetic.
  • Subject has therapy-related MDS (t-MDS).
  • Subject has MDS evolving from a pre-existing myeloproliferative neoplasm (MPN).
  • Subject has MDS/MPN including chronic myelomonocytic leukemia (CMML), atypical chronic myeloid leukemia (CML), juvenile myelomonocytic leukemia (JMML) and unclassifiable MDS/MPN.
  • Subject has received allogeneic HSCT or solid organ transplantation.

Gender

All

Ages

18 Years to 99 Years

Accepts Healthy Volunteers

No

Study Locations and Contact Information (24)

Study Location Distance Name Phone Email
Dana Farber Cancer Institute ID 155361 - Boston, Massachusetts 2.4 miles None None None
Dana Farber Cancer Institute ID 155361 - Boston, Massachusetts 2.4 miles None None None
Dana Farber Cancer Institute ID 155361 - Boston, Massachusetts 2.4 miles None None None
Dana Farber Cancer Institute ID 155361 - Boston, Massachusetts 2.4 miles None None None
University of Massachusetts Worcester ID 155366 - Worcester, Massachusetts 34.2 miles None None None
University of Massachusetts Worcester ID 155366 - Worcester, Massachusetts 34.2 miles None None None
University of Massachusetts Worcester ID 155366 - Worcester, Massachusetts 34.2 miles None None None
University of Massachusetts Worcester ID 155366 - Worcester, Massachusetts 34.2 miles None None None
Columbia University Medical Center ID 156388 - New York, New York 181.2 miles None None None
Columbia University Medical Center ID 156388 - New York, New York 181.2 miles None None None
Columbia University Medical Center ID 156388 - New York, New York 181.2 miles None None None
Columbia University Medical Center ID 156388 - New York, New York 181.2 miles None None None
The University of Chicago ID 155364 - Chicago, Illinois 848.0 miles None None None
The University of Chicago ID 155364 - Chicago, Illinois 848.0 miles None None None
The University of Chicago ID 155364 - Chicago, Illinois 848.0 miles None None None
The University of Chicago ID 155364 - Chicago, Illinois 848.0 miles None None None
University of Colorado Anschutz Cancer Pavilion ID 155365 - Aurora, Colorado 1,759.8 miles None None None
University of Colorado Anschutz Cancer Pavilion ID 155365 - Aurora, Colorado 1,759.8 miles None None None
University of Colorado Anschutz Cancer Pavilion ID 155365 - Aurora, Colorado 1,759.8 miles None None None
University of Colorado Anschutz Cancer Pavilion ID 155365 - Aurora, Colorado 1,759.8 miles None None None
Oregon Health Science University OHSU ID 155360 - Portland, Oregon 2,538.3 miles None None None
Oregon Health Science University OHSU ID 155360 - Portland, Oregon 2,538.3 miles None None None
Oregon Health Science University OHSU ID 155360 - Portland, Oregon 2,538.3 miles None None None
Oregon Health Science University OHSU ID 155360 - Portland, Oregon 2,538.3 miles None None None

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