Efficacy and Safety of Oral Rigosertib in Transfusion-dependent, Low or Int-1 or Trisomy 8 Int-2 Myelodysplastic Syndrome

PHASE2CompletedINTERVENTIONAL
Enrollment

82

Participants

Timeline

Start Date

May 31, 2012

Primary Completion Date

May 31, 2015

Study Completion Date

November 30, 2015

Conditions
Myelodysplastic SyndromeMDSTrisomy 8
Interventions
DRUG

rigosertib

"Rigosertib sodium will be available as soft gel capsules in strengths of 280 mg and 70 mg. Rigosertib will be administered on an outpatient basis.~Patients will take a 560 mg dose (e.g., 2 x 280 mg capsules) of oral rigosertib in the morning and 280 mg dose (e.g., 1 x 280 mg capsules) of oral rigosertib every day of 21-day cycles. Rigosertib should be taken in a fasting state (defined by at least 30 minutes before next meal) BID at 12 hr intervals (with a window of 2 hr). Any vomited dose will be reported as a missed dose.~The patient will fill a diary indicating the day and time of drug intake."

Trial Locations (5)

10032

Columbia University Medical Center, New York

29601

Bon Secours St. Francis Hospital, Greenville

30322

Winship Cancer Institute, Emory University, Atlanta

55905

Mayo Clinic, Rochester

85259

Mayo Clinic, Scottsdale

All Listed Sponsors
lead

Traws Pharma, Inc.

INDUSTRY

NCT01584531 - Efficacy and Safety of Oral Rigosertib in Transfusion-dependent, Low or Int-1 or Trisomy 8 Int-2 Myelodysplastic Syndrome | Biotech Hunter | Biotech Hunter