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

NCT00590187 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2024-06-04

Study results available
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Summary

The objective is to treat elderly AML and MDS patients with sapacitabine.

Conditions

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

Sponsors & Collaborators

  • Cyclacel Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Hagop M Kantarjian, MD · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2018-12-01
Completion
2018-12-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00590187 on ClinicalTrials.gov