We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00380653
Recruitment Status : Completed
First Posted : September 26, 2006
Last Update Posted : October 20, 2009
Information provided by:
Cyclacel Pharmaceuticals, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Leukemias Myelodysplastic Syndromes Drug: sapacitabine Phase 1

Study Type : Interventional  (Clinical Trial)
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
Study Start Date : January 2006
Primary Completion Date : November 2008
Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00380653

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

Responsible Party: Judy H. Chiao, M.D., VP of Clinical Development and Regulatory Affairs, Cyclacel
ClinicalTrials.gov Identifier: NCT00380653     History of Changes
Other Study ID Numbers: CYC682-05-04
First Posted: September 26, 2006    Key Record Dates
Last Update Posted: October 20, 2009
Last Verified: September 2006

Additional relevant MeSH terms:
Myelodysplastic Syndromes
Pathologic Processes
Neoplasms by Histologic Type
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions