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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.
Sponsor:
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00040547
First received: June 28, 2002
Last updated: May 31, 2006
Last verified: May 2006
History of Changes
  Purpose

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
Neoplasms
 Drug: Farnesyl Protein Transferase Inhibitor
 Phase 1

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 Combination With Docetaxel in Advanced Solid Tumors

Resource links provided by NLM:

MedlinePlus related topics: Cancer
Drug Information available for: Docetaxel
U.S. FDA Resources

Further study details as provided by Schering-Plough:

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

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

Estimated Enrollment: 24
Study Start Date: June 2001
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00040547     History of Changes
Other Study ID Numbers: P01964
Study First Received: June 28, 2002
Last Updated: May 31, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by Schering-Plough:
Cancer-Advanced Solid Tumors

Additional relevant MeSH terms:
Neoplasms
Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013