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
  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 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


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)
  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

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00040534     History of Changes
Other Study ID Numbers: P01499
Study First Received: June 28, 2002
Last Updated: February 20, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
Advanced Cancer

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on April 22, 2014