Study of Farnesyl Protein Transferase Inhibitor (FPTI) in Patients With Leukemia (Study P00701)

Leukemia Clinical Trial

Official title:

Safety and Tolerability Study of Farnesyl Protein Transferase Inhibitor (FPTI) in Patients With Leukemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00034684
• Other study ID #: P00701
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: May 1, 2002
• Last updated: June 16, 2015
• Start date: July 2001
• Est. completion date: October 2003

Study information

• Verified date: June 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the safety and tolerability of an oral Farnesyl Protein Transferase Inhibitor (SCH 66336) as a single agent in patients with Advanced Myelodysplastic Syndrome, Acute Myelogenous Leukemia, Chronic Myelogenous Leukemia in Blast Crisis, or Acute Lymphoblastic Leukemia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: October 2003
• Est. primary completion date: October 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Pathologically documented chronic myelogenous leukemia in blast crisis, myelodysplasia, acute myelogenous leukemia, or acute lymphocytic leukemia.

• Life expectancy of 12 weeks or greater.

• ECOG Performance Status less than or equal to 2.

• Meets protocol requirements for specified laboratory values.

• No manifestations of a malabsorption syndrome.

Exclusion Criteria:

• Patients who have received more than three chemotherapy regimens for more than three recurrences of the disease.

• Poor medical risks because of nonmalignant systemic disease as well as those with active uncontrolled conditions.

• Patients who have received investigational therapy of any type within 30 days prior to administration.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blast Crisis
• Leukemia
• Leukemia, Lymphocytic
• Leukemia, Lymphoid
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid
• Leukemia, Myeloid, Chronic
• Myelodysplastic Syndromes
• Preleukemia

Intervention

Drug:
• Farnesyl Protein Transferase Inhibitor

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.