Safety and Tolerability Study of Farnesyl Protein Transferase Inhibitor in Combination With Gemcitabine and Cisplatin in Advanced Cancer (Study P01499)(TERMINATED)
This study has been terminated.
Information provided by (Responsible Party):
First received: June 28, 2002
Last updated: November 6, 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 Gemcitabine and Cisplatin in patients with advanced cancer.
Drug: Farnesyl Protein Transferase Inhibitor
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||July 2004 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Advanced cancer for which there is no treatment available which would have a reasonable chance of disease palliation or cure
- Age greater than or equal to 18.
- SWOG performance Status less than or equal to 2.
- Meets protocol requirements for specified laboratory values.
- Written informed consent and cooperation of patient.
- Prior treatment with an FPTI
- Knowledge of intracranial metastases or carcinomatous meningitis.
- Poor medical risks because of nonmalignant systemic disease or uncontrolled active infection.
- Medical conditions that would interfere with taking oral medications.
- Significant uncontrolled diarrhea.
- Chemotherapy, radiotherapy or major surgery within 4 weeks; full recovery from prior treatment.
- Concomitant use of CYP3A inhibitors/inducers per protocol.
- Known HIV positivity or AIDS-related illness.
- Pregnant or nursing women.
- Men or women of childbearing potential who are not using an effective method of contraception.
- Concurrent chemotherapy, hormonal therapy, radiotherapy or immunotherapy.
- QTc prolongation (>440 msecs) at baseline.
- Patients with previous high-dose therapy requiring stem cell rescue or bone marrow transplant, or irradiation to >30% of bone marrow-containing areas.
- Patients that have received Mitomycin-C or nitrosoureas.
No Contacts or Locations Provided
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||June 28, 2002
||November 6, 2013
||United States: Food and Drug Administration
Keywords provided by Merck:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 04, 2013