Trial | NCT00380653  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    47
The goal of this safety/pharmacology study is to determine MTD of sapacitabine when administered in patients with advanced leukemias or myelodysplastic syndromes.
The goal of this study is to find the highest tolerable dose of sapacitabine that can be given to patients with advanced leukemias or myelodysplastic syndromes.
Study Started
Jan 31
2006
Primary Completion
Nov 30
2008
Study Completion
Jun 30
2009
Last Update
Dec 13
2021

Drug sapacitabine

  • Other names: CYC682

sapacitabine low dose Experimental

sapacitabine administered every 12 hours for 7 days followed by 14 days of rest or every 12 hours for 3 consecutive days per week for 2 weeks followed by 7 days of rest in patients with advanced leukemias or myelodysplastic syndromes The starting dose is (A) 75 mg twice daily x 7 days followed by 14 days of rest; Evaluated doses: 75mg, 100mg, 125mg, 175mg, 225mg, 275mg, 325mg and 375mg

sapacitabine high dose Experimental

The starting dose is 375 mg twice daily x 3 consecutive days per week for 2 weeks followed by 7days of rest. Evaluated doses: 375mg, 425mg and 475mg

Criteria 

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
No Results Posted