CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 105 enrolled
Drug / intervention
Sapacitabine, Arm A +8 moredrug
Likely dose
Sapacitabine, Arm A 200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00590187
NCT00590187Phase 2Completed

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

Cyclacel Pharmaceuticals, Inc.·interventional·Posted Jan 10, 2008·Updated Jun 4, 2024

In Brief

A Phase 2 clinical trial evaluating Sapacitabine, Arm A, Sapacitabine, Arm B, and 7 other interventions for Acute Myeloid Leukemia. Completed, enrolled 105 participants across 15 sites.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 10, 2008
Enrollment StartDec 1, 2007
Primary CompletionDec 1, 2018
TodayJul 2, 2026
Enrollment to primary: 11 yearsPosted 18.5 years ago

Interventions

Sapacitabine, Arm Adrug

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

Sapacitabine, Arm Bdrug

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

Sapacitabine, Arm Cdrug

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

Sapacitabine, Arm Ddrug

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

sapacitabine, Arm Edrug

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

sapacitabine, Arm Fdrug

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

Sapacitabine, Arm Gdrug

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

Sapacitabine, Arm Hdrug

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

Sapacitabine, Arm Idrug

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