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

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

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00034684
Enrollment
132
Registered
2002-05-02
Start date
2001-07-31
Completion date
2003-10-31
Last updated
2015-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blast Crisis, Leukemia, Leukemia, Lymphocytic, Leukemia, Myeloid, Chronic, Myelodysplastic Syndromes

Keywords

Leukemia, Myelodysplastic Syndromes, Leukemia, Myeloid, Leukemia, Lymphocytic

Brief 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.

Interventions

Sponsors

Merck Sharp & Dohme LLC
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026