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

NCT00380653 | Completed Phase 1

• 1 other identifier: CYC682-05-04
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this safety/pharmacology study is to determine MTD of sapacitabine when administered in patients with advanced leukemias or myelodysplastic syndromes.

Conditions

Leukemias; Myelodysplastic Syndromes

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose

  dose limiting toxicities; during first cycle, each cycle is three weeks

  Through study completion, average of 1 year

Study Arms (2)

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

Drug: sapacitabine

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

Drug: sapacitabine

Interventions

sapacitabine DRUG

Also known as: CYC682

sapacitabine high dose; sapacitabine low dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cyclacel Pharmaceuticals, Inc.: lead

Study Sites (1)

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

Related Publications (1)

• Kantarjian H, Garcia-Manero G, O'Brien S, Faderl S, Ravandi F, Westwood R, Green SR, Chiao JH, Boone PA, Cortes J, Plunkett W. Phase I clinical and pharmacokinetic study of oral sapacitabine in patients with acute leukemia and myelodysplastic syndrome. J Clin Oncol. 2010 Jan 10;28(2):285-91. doi: 10.1200/JCO.2009.25.0209. Epub 2009 Nov 23.

  PMID: 19933907 RESULT

Related Links

• Phase I clinical and pharmacokinetic study of oral sapacitabine in patients with acute leukemia and myelodysplastic syndrome.

MeSH Terms

Conditions

Leukemia; Myelodysplastic Syndromes

Interventions

sapacitabine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Diseases

Study Officials

• Judy H Chiao, MD

  Cyclacel Pharmaceuticals, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The starting dose is (A) 75 mg twice daily x 7 days followed by 14 days of rest or, (B) 375 mg twice daily x 3 consecutive days per week for 2 weeks followed by 7days of rest. Evaluated doses in schedule A: 75mg, 100mg, 125mg, 175mg, 225mg, 275mg, 325mg and 375mg Evaluated doses in schedule B: 375mg, 425mg and 475mg

Study Record Dates

• First Submitted: September 23, 2006
• First Posted: September 26, 2006
• Study Start: January 1, 2006
• Primary Completion: November 1, 2008
• Study Completion: June 1, 2009
• Last Updated: December 13, 2021

Record last verified: 2021-12

Locations

US (1)