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


Hauptsponsor: Merck Sharp & Dohme Corp.

Quelle Merck Sharp & Dohme Corp.
Kurze Zusammenfassung

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.

Gesamtstatus Terminated
Anfangsdatum January 2001
Fertigstellungstermin July 2004
Primäres Abschlussdatum July 2004
Phase Phase 1
Studientyp Interventional
Einschreibung 22

Interventionsart: Drug

Interventionsname: Farnesyl Protein Transferase Inhibitor



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.

Geschlecht: All

Mindestalter: 18 Years

Maximales Alter: N/A

Gesunde Freiwillige: No


February 2015

Verantwortliche Partei

Art: Sponsor

Studiendesign Info

Zuweisung: Non-Randomized

Interventionsmodell: Parallel Assignment

Hauptzweck: Treatment

Maskierung: None (Open Label)