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

History of Changes

Tracking Information
First Received Date ^ICMJE	September 23, 2006
Last Updated Date	October 18, 2009
Start Date ^ICMJE	January 2006
Primary Completion Date	November 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00380653 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Safety and Pharmacology Study of Sapacitabine to Treat Advanced Leukemias or Myelodysplastic Syndromes
Official Title ^ICMJE	A Phase I Pharmacologic Study of Oral Sapacitabine in Patients With Advanced Leukemias or Myelodysplastic Syndromes
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Leukemias Myelodysplastic Syndromes
Intervention ^ICMJE	Drug: sapacitabine
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	Not Provided
Completion Date	June 2009
Primary Completion Date	November 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00380653
Other Study ID Numbers ^ICMJE	CYC682-05-04
Has Data Monitoring Committee	Not Provided
Responsible Party	Judy H. Chiao, M.D., VP of Clinical Development and Regulatory Affairs, Cyclacel
Study Sponsor ^ICMJE	Cyclacel Pharmaceuticals, Inc.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Cyclacel Pharmaceuticals, Inc.
Verification Date	September 2006
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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