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ACTIVE NOT RECRUITING
NCT02942290
PHASE1

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

Sponsor: AbbVie

View on ClinicalTrials.gov

Summary

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.

Official title: A Phase 1b Dose Escalation Study Evaluating the Safety and Pharmacokinetics of Venetoclax in Combination With Azacitidine in Subjects With Treatment-Naïve Higher-Risk Myelodysplastic Syndromes (MDS)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

129

Start Date

2017-01-12

Completion Date

2027-01

Last Updated

2025-08-05

Healthy Volunteers

No

Interventions

DRUG

Azacitidine

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.

DRUG

Venetoclax

Oral; Tablet

Locations (37)

Duplicate_University of Arizona Cancer Center - North Campus /ID# 154155

Tucson, Arizona, United States

The University of Chicago Medical Center /ID# 153673

Chicago, Illinois, United States

University of Maryland, Baltimore /ID# 153669

Baltimore, Maryland, United States

Tufts Medical Center /ID# 153672

Boston, Massachusetts, United States

Dana-Farber Cancer Institute /ID# 152735

Boston, Massachusetts, United States

Washington University-School of Medicine /ID# 153671

St Louis, Missouri, United States

Columbia University Medical Center /ID# 153661

New York, New York, United States

Weill Cornell Medical College /ID# 155524

New York, New York, United States

Oregon Medical Research Center /ID# 152734

Portland, Oregon, United States

University of Pittsburgh MC /ID# 153662

Pittsburgh, Pennsylvania, United States

Tennessee Oncology-Nashville Centennial /ID# 222769

Nashville, Tennessee, United States

Vanderbilt University Medical Center /ID# 152738

Nashville, Tennessee, United States

UT MD Anderson Cancer Center /ID# 153809

Houston, Texas, United States

Concord Repatriation General Hospital /ID# 154958

Concord, New South Wales, Australia

Duplicate_St. Vincent's Hospital, Darlinghurst /ID# 222846

Darlinghurst, New South Wales, Australia

St George Hospital /ID# 154954

Kogarah, New South Wales, Australia

Liverpool Hospital /ID# 222410

Liverpool, New South Wales, Australia

Calvary Mater Newcastle /ID# 154957

Waratah, New South Wales, Australia

Duplicate_Princess Alexandra Hospital /ID# 154990

Woolloongabba, Queensland, Australia

Austin Health /ID# 154955

Heidelberg, Victoria, Australia

The Alfred Hospital /ID# 154956

Melbourne, Victoria, Australia

Fiona Stanley Hospital /ID# 222847

Murdoch, Western Australia, Australia

Juravinski Cancer Centre /ID# 152947

Hamilton, Ontario, Canada

Centre Hospitalier Universitaire de Nantes, Hotel Dieu -HME /ID# 153828

Nantes, Pays de la Loire Region, France

Hôpital Saint-Louis /ID# 153827

Paris, France

Universitatsklinikum Mannheim /ID# 153140

Mannheim, Baden-Wurttemberg, Germany

Klinikum rechts der Isar /ID# 153139

Munich, Bavaria, Germany

Universitaetsklinikum Koeln /ID# 153141

Cologne, North Rhine-Westphalia, Germany

Duplicate_Universitaetsklinikum Carl Gus /ID# 153958

Dresden, Saxony, Germany

Universitaetsklinikum Leipzig /ID# 153142

Leipzig, Saxony, Germany

Universitaetsklinikum Halle (Saale) /ID# 153760

Halle, Germany

Duplicate_IRCCS AOU di Bologna - Policlinico Sant'Orsola-Malpighi /ID# 153763

Bologna, Emilia-Romagna, Italy

Duplicate_Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 153764

Rome, Roma, Italy

Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 156492

Norwich, Norfolk, United Kingdom

Oxford University Hospitals NHS Foundation Trust /ID# 222567

Oxford, Oxfordshire, United Kingdom

University Hospitals Birmingham NHS Foundation Trust /ID# 158810

Birmingham, United Kingdom

King's College Hospital NHS Foundation Trust /ID# 156489

London, United Kingdom