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

Neoplasms Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00040534
• Other study ID #: P01499
• Status: Terminated
• Phase: Phase 1
• First received: June 28, 2002
• Last updated: February 13, 2015
• Start date: January 2001
• Est. completion date: July 2004

Study information

• Verified date: February 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 22
• Est. completion date: July 2004
• Est. primary completion date: July 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Neoplasms

Intervention

Drug:
• Farnesyl Protein Transferase Inhibitor

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

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 gemcita — View Citation