A Study Evaluating Venetoclax in Combination With Azacitidine in Participants With Treatment-Naïve Higher-Risk Myelodysplastic Syndromes (MDS)

Part of paid clinical trials in Tucson, Arizona.

Sponsor
AbbVie
Study ID
NCT02942290
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Myelodysplastic Syndromes (MDS)

Eligibility Criteria

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

Interventions

  • Azacitidine — DRUG
    Powder for injection; taken subcutaneously (SC) or intravenous (IV); Administered on Days 1-7 of 28 days cycle or Days 1-5 of Week 1 \& Days 1-2 of Week 2 of 28 day cycle.
  • Venetoclax — DRUG
    Oral; Tablet

Study Details

This is a Phase 1b, open-label, non-randomized, multicenter, dose-finding study evaluating venetoclax in combination with azacitidine in participants with treatment-naïve higher-risk MDS comprising a dose-escalation portion and a safety expansion portion.

Key Dates

Start date
Jan 12, 2017
Status verified
Aug 2025
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027

Study Design

Enrollment
129 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Venetoclax + Azacitidine

Primary Outcome Measure

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

Locations (13)

FacilityCityStateZIPSite coordinators
Duplicate_University of Arizona Cancer Center - North Campus /ID# 154155TucsonArizona85719-1478-
The University of Chicago Medical Center /ID# 153673ChicagoIllinois60637-1443-
University of Maryland, Baltimore /ID# 153669BaltimoreMaryland21201-
Dana-Farber Cancer Institute /ID# 152735BostonMassachusetts02215-
Tufts Medical Center /ID# 153672BostonMassachusetts02111-1552-
Washington University-School of Medicine /ID# 153671St LouisMissouri63110-
Columbia University Medical Center /ID# 153661New YorkNew York10032-3729-
Weill Cornell Medical College /ID# 155524New YorkNew York10065-
Oregon Medical Research Center /ID# 152734PortlandOregon97239-
University of Pittsburgh MC /ID# 153662PittsburghPennsylvania15260-
Tennessee Oncology-Nashville Centennial /ID# 222769NashvilleTennessee37203-1632-
Vanderbilt University Medical Center /ID# 152738NashvilleTennessee37232-0011-
UT MD Anderson Cancer Center /ID# 153809HoustonTexas77030-

Find similar trials in Tucson, AZ

By research site
Duplicate_University of Arizona Cancer Center - North Campus· Tucson, AZThe University of Chicago Medical Center· Chicago, ILUniversity of Maryland, Baltimore· Baltimore, MDDana-Farber Cancer Institute· Boston, MATufts Medical Center· Boston, MAWashington University-School of Medicine· St Louis, MO

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