Efficacy Study of Oral Sapacitabine to Treat Acute Myeloid Leukemia in Elderly Patients

PHASE2CompletedINTERVENTIONAL
Enrollment

105

Participants

Timeline

Start Date

December 31, 2007

Primary Completion Date

December 1, 2018

Study Completion Date

December 1, 2018

Conditions
Acute Myeloid Leukemia
Interventions
DRUG

Sapacitabine, Arm A

200 mg b.i.d. x 7 days every 3-4 weeks

DRUG

Sapacitabine, Arm B

300 mg b.i.d. x 7 days every 3 - 4 weeks

DRUG

Sapacitabine, Arm C

400 mg b.i.d. x 3 days/week x 2 weeks every 3 - 4 weeks

DRUG

Sapacitabine, Arm D

200 mg b.i.d. x 7 consecutive days every 4 weeks

DRUG

sapacitabine, Arm E

300 mg q.d. x 7 consecutive days every 4 weeks

DRUG

sapacitabine, Arm F

300 mg b.i.d. x 3 consecutive days per week for 2 weeks every 4 weeks

DRUG

Sapacitabine, Arm G

200 mg b.i.d. x 7 consecutive days every 4 weeks

DRUG

Sapacitabine, Arm H

300 mg q.d. x 7 consecutive days every 4 weeks

DRUG

Sapacitabine, Arm I

100 mg q.d. x 5 consecutive days per week for 2 weeks every 4 weeks

Trial Locations (15)

10532

New York Medical College, Hawthorne

14263

Roswell Park Cancer Institiute, Buffalo

17033

Penn State Milton S. Hershey Medical Center, Hershey

19104

Hospital of the University of Pennsylvania, Philadelphia

30322

Winship Cancer Institute, Atlanta

35294

University of Alabama at Birmingham, Birmingham

37232

Vanderbilt U Medical Center, Nashville

60611

Northwestern University Feinberg School of Medicine, Chicago

60612

Rush University Medical Center, Chicago

60637

University of Chicago Cancer Research Center, Chicago

68198

University of Nebraska Medical Center, Omaha

90095

UCLA Division of Hematology-Oncology, Los Angeles

94305

Stanford Hospitals and Clinics, Stanford

07601

The Cancer Center at Hackensack University Medical Center, Hackensack

77030-4009

The University of Texas MD Anderson Cancer Center, Houston

Sponsors
All Listed Sponsors
lead

Cyclacel Pharmaceuticals, Inc.

INDUSTRY

NCT00590187 - Efficacy Study of Oral Sapacitabine to Treat Acute Myeloid Leukemia in Elderly Patients | Biotech Hunter | Biotech Hunter