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NCT00380653 Clinical Trial

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

Myelodysplastic Syndromes Clinical Trial

Official title:
A Phase I Pharmacologic Study of Oral Sapacitabine in Patients With Advanced Leukemias or Myelodysplastic Syndromes

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00380653
Other study ID # CYC682-05-04
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date January 2006
Est. completion date June 2009

Study information
Verified date December 2021
Source Cyclacel Pharmaceuticals, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 47
Est. completion date June 2009
Est. primary completion date November 2008
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• sapacitabine

Locations
Country Name City State
United States The University of Texas MD Anderson Cancer Center Houston Texas

Sponsors (1)
Lead Sponsor Collaborator
Cyclacel Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Kantarjian H, Garcia-Manero G, O'Brien S, Faderl S, Ravandi F, Westwood R, Green SR, Chiao JH, Boone PA, Cortes J, Plunkett W. Phase I clinical and pharmacokinetic study of oral sapacitabine in patients with acute leukemia and myelodysplastic syndrome. J — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Maximum tolerated dose dose limiting toxicities; during first cycle, each cycle is three weeks Through study completion, average of 1 year
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