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.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00040534
First received: June 28, 2002
Last updated: February 20, 2014
Last verified: February 2014

June 28, 2002
February 20, 2014
January 2001
July 2004   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00040534 on ClinicalTrials.gov Archive Site
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Safety and Tolerability Study of Farnesyl Protein Transferase Inhibitor in Combination With Gemcitabine and Cisplatin in Advanced Cancer (Study P01499)(TERMINATED)
Not Provided

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Neoplasms
Drug: Farnesyl Protein Transferase Inhibitor
Not Provided
Chow LQ, Eckhardt SG, O'Bryant CL, Schultz MK, Morrow M, Grolnic S, Basche M, Gore L. A phase I safety, pharmacological, and biological study of the farnesyl protein transferase inhibitor, lonafarnib (SCH 663366), in combination with cisplatin and gemcitabine in patients with advanced solid tumors. Cancer Chemother Pharmacol. 2008 Sep;62(4):631-46. Epub 2007 Dec 6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
22
July 2004
July 2004   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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NCT00040534
P01499
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP