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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00034684
Recruitment Status : Completed
First Posted : May 2, 2002
Last Update Posted : June 17, 2015
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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.

Condition or disease Intervention/treatment Phase
Leukemia Myelodysplastic Syndromes Leukemia, Myeloid, Chronic Blast Crisis Leukemia, Lymphocytic Drug: Farnesyl Protein Transferase Inhibitor Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 132 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Tolerability Study of Farnesyl Protein Transferase Inhibitor (FPTI) in Patients With Leukemia
Study Start Date : July 2001
Primary Completion Date : October 2003
Study Completion Date : October 2003

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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.

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00034684     History of Changes
Other Study ID Numbers: P00701
First Posted: May 2, 2002    Key Record Dates
Last Update Posted: June 17, 2015
Last Verified: June 2015

Keywords provided by Merck Sharp & Dohme Corp.:
Myelodysplastic Syndromes
Leukemia, Myeloid
Leukemia, Lymphocytic

Additional relevant MeSH terms:
Myelodysplastic Syndromes
Leukemia, Myeloid
Leukemia, Lymphoid
Blast Crisis
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cell Transformation, Neoplastic
Neoplastic Processes
Myeloproliferative Disorders
Pathologic Processes