M15-522-MDS : A Phase 1b Study Evaluating the Safety and Pharmacokinetics of Venetoclax as a Single-Agent and in Combination With Azacitidine in Subjects With Higher-Risk Myelodysplastic Syndromes After Hypomethylating Agent-Failure

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

OnePhase One

18+Age Over 18

Blood<br/>CancersCancer LocationBlood
Cancers

Systemic therapy | Blood / Myeloma / LymphomaMyelodysplasia

Trial Overview Read MoreRead more

This phase I trial is evaluating an oral drug (Venetoclax) alone and in combination with a chemotherapy drug (Azacitidine - given by injection) in patients with higher-risk Myelodysplastic Syndromes (MDS).
 

This trial is treating patients with Myelodysplastic Syndromes (MDS).

This is a systemic therapy trial.

You may be able to join this trial if:

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

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Scientific Title

A Phase 1b Study Evaluating the Safety and Pharmacokinetics of Venetoclax as a Single-Agent and in Combination With Azacitidine in Subjects With Higher-Risk Myelodysplastic Syndromes After Hypomethylating Agent-Failure

Commercial Sponsor

AbbVie

Summary

Participants in this trial will be allocated to one of three cohorts. In Cohort 1 participants will receive Venetoclax as a monotherapy, in Cohort 2 and 3 (safety expansion cohort) participants will receive Venetoclax in combination with Azacitidine. To be included in this trial, patients must have failure of prior HMA therapy for HR MDS as the firstline treatment for MDS.

Recruiting Hospitals Read MoreRead more

PCCTU (Parkville Cancer Clinical Trials Unit) *
Parkville
Ms Marian Lieschke
marian.lieschke@petermac.org
03 8559 7140

St Vincent's Hospital, Haematology Oncology Research
Fitzroy
Ms Lisa Demosthenous
lisa.demosthenous@svha.org.au
03 9231 3182

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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