Safety and Tolerability Study of Farnesyl Protein Transferase Inhibitor in Combination With Gemcitabine and Cisplatin in Advanced Cancer (Study P01499)(TERMINATED)
1 other identifier
interventional
22
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jan 2001
Typical duration for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2001
CompletedFirst Submitted
Initial submission to the registry
June 28, 2002
CompletedFirst Posted
Study publicly available on registry
July 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2004
CompletedFebruary 16, 2015
February 1, 2015
3.5 years
June 28, 2002
February 13, 2015
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related 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 gemcitabine in patients with advanced solid tumors. Cancer Chemother Pharmacol. 2008 Sep;62(4):631-46. doi: 10.1007/s00280-007-0646-x. Epub 2007 Dec 6.
PMID: 18058098RESULT
MeSH Terms
Conditions
Interventions
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 28, 2002
First Posted
July 1, 2002
Study Start
January 1, 2001
Primary Completion
July 1, 2004
Study Completion
July 1, 2004
Last Updated
February 16, 2015
Record last verified: 2015-02