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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Neoplasms

Treatments: Drug: Farnesyl Protein Transferase Inhibitor

Study type: Interventional

Funder types: Industry

Identifiers

NCT00040547

P01964

Details and patient eligibility

About

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.

Enrollment: 29 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)