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Farnesyl Protein Transferase Inhibitor (FPTI) in Combination With Docetaxel in Advanced Solid Tumors (Study P01964)(COMPLETED)

This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: June 28, 2002
Last updated: February 16, 2015
Last verified: February 2015
The purpose of this study is to determine the safety and tolerability of an oral Farnesyl Protein Transferase Inhibitor (SCH 66336) when given in combination with intravenous docetaxel in cancer patients with advanced solid tumors.

Condition Intervention Phase
Drug: Farnesyl Protein Transferase Inhibitor
Phase 1

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 Combination With Docetaxel in Advanced Solid Tumors

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Adverse Events
  • Laboratory Tests
  • ECG

Secondary Outcome Measures:
  • Physical Exam
  • Pharmacokinetics
  • Tumor Response

Enrollment: 29
Study Start Date: June 2001
Study Completion Date: February 2004
Primary Completion Date: February 2004 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Male or Female
  • Measurable or evaluable disease
  • No more than 2 prior chemotherapy regimens.
  • Age greater than or equal to 18.
  • Karnofsky Performance Status greater than or equal to 70%.
  • Meets protocol requirements for specified laboratory values.
  • No manifestations of a malabsorption syndrome.
  • Written informed consent and cooperation of patient
  • Appropriate use of effective contraception if of child-bearing potential.


  • Acute or chronic leukemia or multiple myeloma.
  • Evidence of 2 or more active malignancies, expect for in situ or adequately treated basal or squamous cell skin cancer.
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No Contacts or Locations Provided
  More Information

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00040547     History of Changes
Other Study ID Numbers: P01964
Study First Received: June 28, 2002
Last Updated: February 16, 2015

Keywords provided by Merck Sharp & Dohme Corp.:
Cancer-Advanced Solid Tumors

Additional relevant MeSH terms:
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action processed this record on April 26, 2017