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

Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00040547
• Other study ID #: P01964
• Status: Completed
• Phase: Phase 1
• First received: June 28, 2002
• Last updated: February 16, 2015
• Start date: June 2001
• Est. completion date: February 2004

Study information

• Verified date: February 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: February 2004
• Est. primary completion date: February 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasms

Intervention

Drug:
• Farnesyl Protein Transferase Inhibitor

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events
Primary	Laboratory Tests
Primary	ECG
Secondary	Physical Exam
Secondary	Pharmacokinetics
Secondary	Tumor Response