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


Phase 1
18 Years
65 Years
Not Enrolling
Both
Neoplasms

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Trial Information

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

Inclusion 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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Adverse Events

Authority:

United States: Food and Drug Administration

Study ID:

P01964

NCT ID:

NCT00040547

Start Date:

June 2001

Completion Date:

Related Keywords:

  • Neoplasms
  • Cancer-Advanced Solid Tumors
  • Neoplasms

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