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):
Merck Sharp & Dohme Corp.
First received: June 28, 2002
Last updated: February 16, 2015
Last verified: February 2015
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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
No Contacts or Locations Provided
No publications provided
||Merck Sharp & Dohme Corp.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||June 28, 2002
||February 16, 2015
||United States: Food and Drug Administration
Keywords provided by Merck Sharp & Dohme Corp.:
ClinicalTrials.gov processed this record on August 02, 2015
Cancer-Advanced Solid Tumors