ONCONOVA 04-30 : A Phase III, International, Randomized, Controlled Study of Rigosertib Versus Physician's Choice of Treatment in Patients With Myelodysplastic Syndrome After Failure of a Hypomethylating Agent

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

ThreePhase Three

18-79Age 18-79

Blood<br/>CancersCancer LocationBlood
Cancers

Systemic therapy | Blood / Myeloma / LymphomaMyelodysplasia

Trial Overview Read MoreRead more

This phase III trial is comparing a standard therapy with the investigational agent (Rigosertib) for the treatment of Myelodysplastic Syndrome.
 

This trial is treating patients with Myelodysplasia.

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 been diagnosed with a prior or secondary type of cancer.
  • You have previously been treated (or are currently being treated) on a clinical trial.

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

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

A Phase III, International, Randomized, Controlled Study of Rigosertib Versus Physician's Choice of Treatment in Patients With Myelodysplastic Syndrome After Failure of a Hypomethylating Agent

Commercial Sponsor

Onconova Therapeutics, Inc.

Summary

This is a Phase III, open label, randomised, controlled international study. There are approximately 100 sites. Inclusion of approximately 225 patients who are less than 80 years of age with MDS classified as RAEB-1, RAEB-2, or RAEB-t who received AZA or DEC for 9 months and had their last dose within 6 months prior to screening. Patients will be stratified by: Very high risk (VHR) vs. non-VHR per IPSS-R, Geographic region (North America vs. Europe vs. Asia) and randomly assigned in a 2:1 ratio into two treatment groups. The two groups are as follows: 1. Rigosertib 1800 mg / 24 hr administered as a 72 hr CIV infusion on Days 1, 2 and 3, on a 2 week cycle for the first 8 cycles, and on days 1, 2, and 3 on a 4 week cycle thereafter (N = approximately 150 patients). 2. Physician's choice of alternative treatment, which may include any approved or standard of care therapy based on frequently used treatment for MDS after receipt of HMA's (N = approximately 75 patients). No experimental therapies are allowed on this arm. Patients will be treated until 2006 IG progression criteria are met or until an unacceptable level of toxicity or intolerance. For all radnomised patients who discontinue study treatment, subsequent therapies will be documented until death. Patients in the PC group will not be allowed to cross-over to the Rigosertib group. All patients will be allowed, as medically justified, access to RBC and platelet transfusions and growth factors.

Recruiting Hospitals Read MoreRead more

Monash Health Haematology Research Unit
Clayton
Ms Anita Cummins
anita.cummins@southernhealth.org.au
03 9594 4044

Not Recruiting Hospitals Read MoreRead more

Closed

Peninsula & South Eastern Haematology and Oncology Group
Frankston
Mr Albert Goikman
ag@paso.com.au
03 9771 8918

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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