04-30: Rigosertib in Patients with Myelodysplastic Syndrome
Research type
Research Study
Full 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
IRAS ID
191114
Contact name
Ghulam Mufti
Contact email
Sponsor organisation
Onconova Therapeutics, Inc.
Eudract number
2015-001476-22
Duration of Study in the UK
2 years, 10 months, 16 days
Research summary
Research Summary
Rigosertib is being studied as a new potential anticancer drug and as potential treatment for myelodysplastic syndrome (MDS) also known as myelodysplasia. Although the mechanism of action of rigosertib is not fully known, it is thought to target cancer cell growth and survival by reducing tumour cell functions such as cell division, growth and metabolism (the chemical reactions necessary for the survival of a cell) thereby causing the tumour cells to die.This is a randomised study which means participants will have a two in three chance of receiving the study drug (rigosertib) plus best supportive care (Group 1). There is a one in three chance that participants will receive standard care as determined by the study doctor, the comparison arm called “physician’s choice” (Group 2). Patients randomized to group 1, will receive rigosertib as an infusion into a vein over 72 consecutive hours once every other week for the first 16 weeks, then once every 4 weeks until the patient’s disease progresses.
Patients are expected to continue taking the study drug until their disease progresses.
Approximately 225 patients internationally between ages 18-79 years at screening who meet the eligibility requirements will take part in this study. The study is being sponsored by Onconova Therapeutics Inc.
Summary of Results
Abstract: The purpose of the study was to assess whether rigosertib provided benefit in terms of extending life compared to other treatment options for high-risk MDS participants after failure of a hypomethylating agent such as azacitidine or decitabine. Some of the participants received rigosertib, while others were assigned the treatment recommended by their doctor. Three hundred and seventy-two participants, including males and females, from 25 countries took part in the study. The study showed that there was no survival benefit for those participants that received rigosertib as compared to those that received other treatments. Rigosertib was generally well tolerated by the participants.Further detailed results will be posted on EudraCT by the end of June 2022.
REC name
West of Scotland REC 1
REC reference
15/WS/0274
Date of REC Opinion
24 Dec 2015
REC opinion
Further Information Favourable Opinion