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.

First Received: June 28, 2002 Last Updated: May 31, 2006 History of Changes

Sponsor:	Schering-Plough
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00040534

Purpose

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.

Condition	Intervention	Phase
Neoplasms	Drug: Farnesyl Protein Transferase Inhibitor	Phase I

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety Study

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by Schering-Plough:

Estimated Enrollment:	24
Study Start Date:	January 2001

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Study ID Numbers:	P01499
Study First Received:	June 28, 2002
Last Updated:	May 31, 2006
ClinicalTrials.gov Identifier:	NCT00040534 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Schering-Plough:

Advanced Cancer

Additional relevant MeSH terms:

Neoplasms

ClinicalTrials.gov processed this record on November 27, 2009