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

Part of paid clinical trials in Tucson, Arizona.

Sponsor
AbbVie
Study ID
NCT02966782
Phase
PHASE1
Status
Completed

Conditions

  • Myelodysplastic Syndromes (MDS)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • venetoclax — DRUG
    Tablet
  • azacitidine — DRUG
    Powder for injection, subcutaneously or intravenous

Study Details

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).

Key Dates

Start date
Mar 7, 2017
Status verified
May 2023
Primary completion
Apr 5, 2023
Completion
Apr 5, 2023

Study Design

Enrollment
70 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Venetoclax monotherapy (Cohort 1)
  • Experimental: Venetoclax + azacitidine (Cohort 2)
  • Experimental: Safety Expansion (Cohort 3)

Primary Outcome Measure

AUCt for azacitidine [ Time Frame: Up to 32 days ]

Locations (10)

FacilityCityStateZIPSite coordinators
University of Arizona Cancer Center - North Campus /ID# 157503TucsonArizona85719-1478-
University of Colorado Hospital /ID# 155365AuroraColorado80045-
Yale University /ID# 162544New HavenConnecticut06510-
Duplicate_University of Chicago /ID# 155364ChicagoIllinois60637-
Dana-Farber Cancer Institute /ID# 155361BostonMassachusetts02215-
Pediatric Endocrine Associates /ID# 171227BostonMassachusetts02114-
University of Massachusetts - Worcester /ID# 155366WorcesterMassachusetts01655-
Columbia Univ Medical Center /ID# 156388New YorkNew York10032-3725-
Oregon Health and Science University /ID# 155360PortlandOregon97239-
University of Texas MD Anderson Cancer Center /ID# 155362HoustonTexas77030-

Find similar trials in Tucson, AZ

By research site
University of Arizona Cancer Center - North Campus· Tucson, AZUniversity of Colorado Hospital· Aurora, COYale University· New Haven, CTDuplicate_University of Chicago· Chicago, ILDana-Farber Cancer Institute· Boston, MAPediatric Endocrine Associates· Boston, MA

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