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

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.
ClinicalTrials.gov Identifier: NCT00040547
Recruitment Status : Completed
First Posted : July 1, 2002
Last Update Posted : February 18, 2015
Sponsor:
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) when given in combination with intravenous docetaxel in cancer patients with advanced solid tumors.

Condition or disease Intervention/treatment Phase
Neoplasms Drug: Farnesyl Protein Transferase Inhibitor Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 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 Combination With Docetaxel in Advanced Solid Tumors
Study Start Date : June 2001
Primary Completion Date : February 2004
Study Completion Date : February 2004

Resource links provided by the National Library of Medicine

Drug Information available for: Docetaxel
U.S. FDA Resources




Primary Outcome Measures :
  1. Adverse Events
  2. Laboratory Tests
  3. ECG

Secondary Outcome Measures :
  1. Physical Exam
  2. Pharmacokinetics
  3. Tumor Response


Information from the National Library of Medicine

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

Inclusion:

  • 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.

Exclusion:

  • 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.

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00040547     History of Changes
Other Study ID Numbers: P01964
First Posted: July 1, 2002    Key Record Dates
Last Update Posted: February 18, 2015
Last Verified: February 2015

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

Additional relevant MeSH terms:
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action