Last updated on October 2017

Controlled Study of Rigosertib Versus Physician's Choice of Treatment in MDS Patients After Failure of an HMA


Brief description of study

The study's primary objective [in a population of patients with MDS after failure of treatment with azacitidine (AZA) or decitabine (DAC)], is to compare the overall survival (OS) of patients in the rigosertib group vs the Physician's Choice group, in all patients and in a subgroup of patients with IPSS-R very high risk.

Detailed Study Description

This is a Phase III, open-label, randomized, controlled, international study. Approximately 225 patients < 82 years of age with MDS classified as RAEB-1, RAEB-2, or RAEB-t who received AZA or DAC for ≤ 9 months and/or ≤ 9 cycles over 12 months and had their last dose of AZA or DAC within 6 months prior to screening will be stratified by: - Very high risk (VHR) vs non-VHR per IPSS-R, and - Geographic region (North America vs Europe vs Asia; because approved products and standard of care may vary by region), and randomly assigned in a 2:1 ratio to one of the following 2 treatment groups: - Rigosertib 1800 mg/24 hr administered as a 72 hr CIV infusion on Days 1, 2, and 3 of a 2 week cycle for the first 8 cycles, and on Days 1, 2, and 3 of a 4-week cycle thereafter (N = approximately 150 patients); - Physician's Choice of alternative treatment, which may include any approved or standard-of-care therapy that the patient has not shown to be hypersensitive to, based on frequently used treatment for MDS, as per institutional guidelines, after receipt of HMAs (N = approximately 75 patients). The drugs used in the Physician's Choice arm should be used according to the recommendations, if clinically appropriate, provided in the corresponding Summary of Product Characteristics (SmPC) and Prescribing Information of these drugs. Experimental therapies are not allowed on the PC arm. Patients will be treated until 2006 IWG progression criteria are met (ie, 50% increase of BM blasts or worsening of cytopenias) or until an unacceptable toxicity or intolerance. For all randomized patients who discontinue study treatment, subsequent therapies with their start and end dates, as well as survival time after treatment discontinuation, will be documented at least monthly until death. Patients in the PC group who progress will not be allowed to cross over to rigosertib. All patients in both treatment groups will be allowed, as medically justified, access to RBC and platelet transfusions and to growth factors (granulocyte colony-stimulating factor (G-CSF), erythropoietin, and thrombopoietin).

Clinical Study Identifier: NCT02562443

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Rafael Bejar, MD, PhD

UC San Diego Moores Cancer Center
La Jolla, CA United States
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Casey O'Connell, MD

USC Norris Comprehensive Cancer Center
Los Angeles, CA United States
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Gary J. Schiller, MD

UCLA Medical Center
Los Angeles, CA United States
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Wylie D. Hosmer, MD

Cancer Center of Central Connecticut
Plainville, CT United States
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Mehdi Moezi, MD

Cancer Specialists of North Florida
Fleming Island, FL United States
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Christopher R. Cogle, MD

UF Health Shands Cancer Hospital
Gainesville, FL United States
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Santosh Nair, MD

Mid Florida Hematology and Oncology Centers
Orange City, FL United States
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Jamile Shammo, MD

Rush University Medical Center
Chicago, IL United States
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Irum Khan, MD

University of Illinois Cancer Center
Chicago, IL United States
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Lucy A. Godley, MD, PhD

The University of Chicago Medical Center
Chicago, IL United States
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Patrick J. Stiff, MD

Loyola University Chicago at Loyola University Medical Center
Maywood, IL United States
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S. Hamid Sayar, MD

Indiana University Health Hospital
Indianapolis, IN United States
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Abdulraheem M. Yacoub, MD

The University of Kansas Cancer Center
Westwood, KS United States
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Hana Safah, MD

Tulane Medical Center
New Orleans, LA United States
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Maria R. Baer, MD

University of Maryland Greenebaum Cancer Center
Baltimore, MD United States
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Ralph V. Boccia, MD

Center for Cancer and Blood Disorders (Regional Cancer Care Associates LLC)
Bethesda, MD United States
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Kellie Sprague, MD

Tufts Medical Center
Boston, MA United States
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Joseph Morgan, MD

Henry Ford Hospital
Detroit, MI United States
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Erica Warlick, MD

University of Minnesota Physicians Bone Marrow Transplant Clinic
Minneapolis, MN United States
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Aref Al-Kali, MD

Mayo Clinic
Rochester, MN United States
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Kenneth Blankstein, MD

Hunterdon Medical Center
Flemington, NJ United States
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Stefan Faderl, MD

John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, NJ United States
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Dale Schaar, MD, PhD

Rutgers Cancer Institute of New Jersey
New Brunswick, NJ United States
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Jason Suh, MD

The Valley Hospital
Ridgewood, NJ United States
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Cecilia Arana Yi, MD

The University of New Mexico Comprehensive Cancer Center
Albuquerque, NM United States
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Steven Allen, MD

Northwell Health
Lake Success, NY United States
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Lewis R. Silverman, MD

Mount Sinai School of Medicine
New York, NY United States
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Mark Heaney, MD

Columbia University Medical Center
New York, NY United States
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Gail J. Roboz, MD

New York Presbyterian Hospital - Weill Cornell Medical Center
New York, NY United States
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Karen Seiter, MD

New York Medical College
Valhalla, NY United States
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Hyatt P. (Tracy) DeGreen III, ...

Lancaster Cancer Center
Lancaster, PA United States
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Selina Luger, MD

Hospital of the University of Pennsylvania
Philadelphia, PA United States
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Claudia M. Dourado, MD

Albert Einstein Medical Center, Cancer Center
Philadelphia, PA United States
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Suzanne R. Fanning, DO

Greenville Health System (GHS) Cancer Institute
Greenville, SC United States
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Vikas Bhushan, MD

Texas Oncology-Medical City Dallas
Dallas, TX United States
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Robert Collins, MD

UT Southwestern Medical Center
Dallas, TX United States
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Guillermo Garcia-Manero, MD

MD Anderson Cancer Center
Houston, TX United States
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Vincent L. Hansen, MD

Northern Utah Associates
Ogden, UT United States
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Michael Keng, MD

Emily Couric Clinical Cancer Center
Charlottesville, VA United States
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Bart Scott, MD

Seattle Cancer Care Alliance (SCCA)
Seattle, WA United States
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Ryan Mattison, MD

University of Wisconsin Clinical Science Center
Madison, WI United States
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Richard John Mercier, MD

Marshfield Clinic - Marshfield Center
Marshfield, WI United States
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David Ma, MD

St Vincent's Hospital Sydney
Darlinghurst, Australia
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Simon Durrant

Icon Cancer Care Icon South Brisbane
South Brisbane, Australia
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Rosemary Anne Harrup, MD

Royal Hobart Hospital
Hobart, Australia
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Joseph Morgan, MD

Peninsula and South Eastern Hematology and Oncology Group
Frankston, Australia
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Jake Shortt, MD, PhD

Monash Health, Monash Medical Centre
Melbourne, Australia
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Sigrid Machherndl-Spandl, MD

Hospital of the Elisabethinen Linz GmbH
Linz, Austria
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Richard Greil, MD

Salzburg University Hospital
Salzburg, Austria
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Michael Pfeilstöcker, MD

Hanusch Hospital
Vienna, Austria
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Dimitri Breems, MD

Antwerp Hospital Network Stuivenberg
Antwerp, Belgium
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Dominik Selleslag

General Hospital Saint-Jan
Brugge, Belgium
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Dominiek Mazure, MD

University Hospital Ghent
Ghent, Belgium
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Mariëlle Beckers, PhD

University Hospital Leuven, Campus Gasthuisberg
Leuven, Belgium
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Carlos Graux, MD

CHU UCL Namur - Site Godinne
Yvoir, Belgium
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Nancy Zhu, MD

University of Alberta Hospital
Edmonton, AB Canada
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Rajat Kumar, MD

CancerCare Manitoba
Winnipeg, MB Canada
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Brian Leber

Juravinski Cancer Centre
Hamilton, ON Canada
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Rena Buckstein, MD

Sunnybrook Research Institute
Toronto, ON Canada
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Karen Yee, MD

Princess Margaret Cancer Centre
Toronto, ON Canada
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Sarit Assouline, MD

Jewish General Hospital
Montreal, QC Canada
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