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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00034684
First received: May 1, 2002
Last updated: June 30, 2014
Last verified: June 2014
  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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00034684     History of Changes
Other Study ID Numbers: P00701
Study First Received: May 1, 2002
Last Updated: June 30, 2014
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on September 16, 2014