Farnesyl Protein Transferase Inhibitor (FPTI) in Combination With Docetaxel in Advanced Solid Tumors (Study P01964)(COMPLETED)
This study has been completed.
Information provided by (Responsible Party):
First received: June 28, 2002
Last updated: November 13, 2013
Last verified: November 2013
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.
Drug: Farnesyl Protein Transferase Inhibitor
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
||Safety and Tolerability Study of Farnesyl Protein Transferase Inhibitor (FPTI) in Combination With Docetaxel in Advanced Solid Tumors
Primary Outcome Measures:
- Adverse Events
- Laboratory Tests
Secondary Outcome Measures:
- Physical Exam
- Tumor Response
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||February 2004 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years to 65 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
No Contacts or Locations Provided
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||June 28, 2002
||November 13, 2013
||United States: Food and Drug Administration
Keywords provided by Merck:
Cancer-Advanced Solid Tumors
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 03, 2013