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

This study has been completed.
Sponsor:
Information provided by:
Cyclacel Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00380653
First received: September 23, 2006
Last updated: October 18, 2009
Last verified: September 2006

September 23, 2006
October 18, 2009
January 2006
November 2008   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00380653 on ClinicalTrials.gov Archive Site
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Safety and Pharmacology Study of Sapacitabine to Treat Advanced Leukemias or Myelodysplastic Syndromes
A Phase I Pharmacologic Study of Oral Sapacitabine in Patients With Advanced Leukemias or Myelodysplastic Syndromes

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

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Leukemias
  • Myelodysplastic Syndromes
Drug: sapacitabine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
June 2009
November 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00380653
CYC682-05-04
Not Provided
Judy H. Chiao, M.D., VP of Clinical Development and Regulatory Affairs, Cyclacel
Cyclacel Pharmaceuticals, Inc.
Not Provided
Not Provided
Cyclacel Pharmaceuticals, Inc.
September 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP