Safety and Tolerability Study of Farnesyl Protein Transferase Inhibitor in Combination With Gemcitabine and Cisplatin in Advanced Cancer (Study P01499)(TERMINATED) - Tabular View

Tracking Information
First Received Date ^ICMJE	June 28, 2002
Last Updated Date	May 31, 2006
Start Date ^ICMJE	January 2001
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00040534 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Safety and Tolerability Study of Farnesyl Protein Transferase Inhibitor in Combination With Gemcitabine and Cisplatin in Advanced Cancer (Study P01499)(TERMINATED)
Official Title ^ICMJE
Brief 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 Gemcitabine and Cisplatin in patients with advanced cancer.
Detailed Description
Study Phase	Phase I
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety Study
Condition ^ICMJE	Neoplasms
Intervention ^ICMJE	Drug: Farnesyl Protein Transferase Inhibitor
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	24
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	Inclusion Criteria: 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. Exclusion Criteria: 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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE

Administrative Information
NCT ID ^ICMJE	NCT00040534
Responsible Party
Study ID Numbers ^ICMJE	P01499
Study Sponsor ^ICMJE	Schering-Plough
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Schering-Plough
Verification Date	May 2006
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP