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

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

Sponsors

Lead sponsor: Merck Sharp & Dohme Corp.

Source 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.

Overall Status Completed
Start Date June 2001
Completion Date February 2004
Primary Completion Date February 2004
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
Adverse Events
Laboratory Tests
ECG
Secondary Outcome
Measure Time Frame
Physical Exam
Pharmacokinetics
Tumor Response
Enrollment 29
Condition
Intervention

Intervention type: Drug

Intervention name: Farnesyl Protein Transferase Inhibitor

Eligibility

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.

Gender: All

Minimum age: 18 Years

Maximum age: 65 Years

Healthy volunteers: No

Verification Date

February 2015

Responsible Party

Responsible party type: Sponsor

Keywords
Study Design Info

Allocation: Non-Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov