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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00034684
First Posted: May 2, 2002
Last Update Posted: June 17, 2015
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.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  Purpose
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 Intervention Phase
Leukemia Myelodysplastic Syndromes Leukemia, Myeloid, Chronic Blast Crisis Leukemia, Lymphocytic Drug: Farnesyl Protein Transferase Inhibitor Phase 1 Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Enrollment: 132
Study Start Date: July 2001
Study Completion Date: October 2003
Primary Completion Date: October 2003 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00034684     History of Changes
Other Study ID Numbers: P00701
First Submitted: May 1, 2002
First Posted: May 2, 2002
Last Update Posted: June 17, 2015
Last Verified: June 2015

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

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