Safety and Pharmacology Study of Sapacitabine to Treat Advanced Leukemias or Myelodysplastic Syndromes

Phase 1

Completed

• Conditions: Leukemias; Myelodysplastic Syndromes
• Interventions: Drug: sapacitabine

• Registration Number: NCT00380653
• Lead Sponsor: Cyclacel Pharmaceuticals, Inc.

Brief Summary

The goal of this safety/pharmacology study is to determine MTD of sapacitabine when administered in patients with advanced leukemias or myelodysplastic syndromes.

Detailed Description

The goal of this study is to find the highest tolerable dose of sapacitabine that can be given to patients with advanced leukemias or myelodysplastic syndromes.

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2006-09-23
• Study First Submitted QC: 2006-09-23
• Study First Posted: 2006-09-26
• Primary Completion: 2008-11
• Study Completion: 2009-06
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-07
• Last Update Posted: 2021-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

• Adult patients with advanced leukemias or myelodysplastic syndromes defined in section 4.1; Eastern Cooperative Oncology Group performance status 0-2; adequate hepatic and renal function; ability to swallow capsules; be at least 2 weeks from prior chemotherapy, radiation therapy, major surgery or other investigational anticancer therapy; and have recovered from prior toxicities.

Exclusion Criteria

• Patients with known CNS involvement by leukemia; plan to undergo allogeneic bone marrow transplant within 4 weeks; currently on other investigational agents; uncontrolled intercurrent illnesses; pregnant or lactating women; known to be HIV positive

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
sapacitabine high dose	sapacitabine	The starting dose is 375 mg twice daily x 3 consecutive days per week for 2 weeks followed by 7days of rest. Evaluated doses: 375mg, 425mg and 475mg
sapacitabine low dose	sapacitabine	sapacitabine administered every 12 hours for 7 days followed by 14 days of rest or every 12 hours for 3 consecutive days per week for 2 weeks followed by 7 days of rest in patients with advanced leukemias or myelodysplastic syndromes The starting dose is (A) 75 mg twice daily x 7 days followed by 14 days of rest; Evaluated doses: 75mg, 100mg, 125mg, 175mg, 225mg, 275mg, 325mg and 375mg

Primary Outcome Measures

Name	Time	Method
Maximum tolerated dose	Through study completion, average of 1 year	dose limiting toxicities; during first cycle, each cycle is three weeks

Trial Locations

Locations (1)

The University of Texas MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States