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

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

Condition Intervention Phase
Leukemias Myelodysplastic Syndromes Drug: sapacitabine Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Pharmacologic Study of Oral Sapacitabine in Patients With Advanced Leukemias or Myelodysplastic Syndromes

Resource links provided by NLM:

Further study details as provided by Cyclacel Pharmaceuticals, Inc.:

Study Start Date: January 2006
Study Completion Date: June 2009
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00380653

United States, Texas
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
Cyclacel Pharmaceuticals, Inc.
  More Information

Responsible Party: Judy H. Chiao, M.D., VP of Clinical Development and Regulatory Affairs, Cyclacel Identifier: NCT00380653     History of Changes
Other Study ID Numbers: CYC682-05-04
Study First Received: September 23, 2006
Last Updated: October 18, 2009

Additional relevant MeSH terms:
Myelodysplastic Syndromes
Pathologic Processes
Neoplasms by Histologic Type
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions processed this record on August 17, 2017