NCT00590187

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

A Randomized Phase 2 Study of Oral Sapacitabine in Elderly Patients With Acute Myeloid Leukemia Previously Untreated or in First Relapse, or Previously Treated Myelodysplastic Syndromes

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: Cyclacel Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

The main objective of this study is to learn which sapacitabine treatment is more likely to keep the cancer in check for at least one year in AML patients who are at least 70 years of age or older and in MDS patients who are at least 60 years of age.

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
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

Timeline

• Start date: 2007-12-01
• Primary completion: 2018-12-01
• Completion: 2018-12-01
• First posted: 2008-01-10
• Last updated: 2024-06-04
• Results posted: 2024-06-04

Locations

15 sites across 1 country: United States