This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: May 1, 2002
Last updated: June 16, 2015
Last verified: June 2015
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: 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)

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.
  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

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00034684     History of Changes
Other Study ID Numbers: P00701
Study First Received: May 1, 2002
Last Updated: June 16, 2015

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

Additional relevant MeSH terms:
Myelodysplastic Syndromes
Leukemia, Myeloid
Blast Crisis
Leukemia, Lymphoid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Cell Transformation, Neoplastic
Neoplastic Processes
Myeloproliferative Disorders
Pathologic Processes
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases processed this record on June 23, 2017