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

NCT ID: NCT00040547

Last Updated: 2015-02-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-06-30
• Study Completion Date: 2004-02-29

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.

Conditions

Neoplasms

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Farnesyl Protein Transferase Inhibitor

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

P01964

Identifier Type: -

Identifier Source: org_study_id