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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)

This study has been terminated.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: June 28, 2002
Last updated: February 13, 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 Gemcitabine and Cisplatin in patients with advanced cancer.

Condition Intervention Phase
Neoplasms Drug: Farnesyl Protein Transferase Inhibitor Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Further study details as provided by Merck Sharp & Dohme Corp.:

Enrollment: 22
Study Start Date: January 2001
Study Completion Date: July 2004
Primary Completion Date: July 2004 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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
  More Information

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00040534     History of Changes
Other Study ID Numbers: P01499
Study First Received: June 28, 2002
Last Updated: February 13, 2015

Keywords provided by Merck Sharp & Dohme Corp.:
Advanced Cancer processed this record on August 18, 2017