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


Phase 1
18 Years
N/A
Not Enrolling
Both
Leukemias, Myelodysplastic Syndromes

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

CYC682-05-04

NCT ID:

NCT00380653

Start Date:

January 2006

Completion Date:

June 2009

Related Keywords:

  • Leukemias
  • Myelodysplastic Syndromes
  • Leukemia
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location

The University of Texas MD Anderson Cancer Center Houston, Texas  77030-4009