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

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00040534

Enrollment

Registered

2002-07-01

Start date

2001-01-31

Completion date

2004-07-31

Last updated

2015-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neoplasms

Keywords

Advanced Cancer

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.

Interventions

DRUGFarnesyl Protein Transferase Inhibitor

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026