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Clinical Trials/NCT00040547
NCT00040547CompletedPhase 1

Safety and Tolerability Study of Farnesyl Protein Transferase Inhibitor (FPTI) in Combination With Docetaxel in Advanced Solid Tumors

Merck Sharp & Dohme LLC0 sites29 target enrollmentStarted: June 1, 2001Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
29
Primary Endpoint
ECG
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Male or Female
  • •Measurable or evaluable disease
  • •No more than 2 prior chemotherapy regimens.
  • •Age greater than or equal to
  • •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 Criteria

  • •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.

Outcomes

Primary Outcomes

ECG

Adverse Events

Laboratory Tests

Secondary Outcomes

  • Pharmacokinetics
  • Physical Exam
  • Tumor Response

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

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