A Study Evaluating Venetoclax Alone and in Combination With Azacitidine in Subjects With Relapsed/Refractory Myelodysplastic Syndromes (MDS)

  • Interventional
  • Recruiting
  • NCT02966782
Eligibility Details Visit Clinicaltrials.gov

A Phase 1b Study Evaluating the Safety and Pharmacokinetics of Venetoclax as a Single-Agent and in Combination With Azacitidine in Subjects With Relapsed/Refractory Myelodysplastic Syndromes

This is a Phase 1b, 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 relapsed/refractory Myelodysplastic Syndromes (MDS).

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

Inclusion Criteria:

         - Subjects who have relapsed or refractory MDS.

         - Subject enrolled in venetoclax monotherapy must have documented failure of prior therapy with a hypomethylating agent (HMA). HMA-failure is defined as:

             1. Relapse after initial complete or partial response or hematological improvement after at least 4 cycles of azacitidine or at least 4 cycles of decitabine within the last 5 years, OR

             2. Failure to achieve complete or partial response or hematological improvement after at least 4 cycles of azacitidine or at least 4 cycles of decitabine within the last 5 years

         - Subjects must have presence of < 20% bone marrow blasts per bone marrow biopsy/aspirate at screening.

         - Subject is not a candidate to undergo allogenic hematopoietic stem cell transplantation (HSCT).

         - Subject must have an Eastern Cooperative Oncology Group (ECOG) performance score of ≤2.

         - Subject must have adequate hematologic, renal, and hepatic function.

        Exclusion Criteria:

         - Subject has received prior therapy with a BH3 mimetic.

         - 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.

         - Subject has received a live attenuated vaccine within 4 weeks prior to the first dose of study drug.

         - Subject is pregnant or breastfeeding.

At a Glance

National Government IDNCT02966782

IRB#IRB16-1519

Lead SponsorAbbVie

Lead PhysicianOlatoyosi Odenike

Collaborator(s)N/A

EligibilityAll
18 Years and up
Recruiting