A Phase III, Double-Blind, Placebo Controlled Trial of Gemcitabine Plus Placebo Versus Gemcitabine Plus R115777 in Patients With Advanced Pancreatic Cancer
This is a randomized (study drug assigned by chance), double-blind (neither the investigator
or patient will know the identity of the assigned treatment) to compare the overall survival
of patients with advanced pancreatic cancer after treatment with gemcitabine with and
without tipifarnib (referred to as R115777). Gemcitabine is an approved chemotherapy agent
administered intravenously (iv) (though a vein) for patients with advanced pancreatic
cancer. R115777 is an orally (by mouth) administered investigational drug that is being
tested in combination with gemcitabine for the treatment of patients with advanced
pancreatic cancer. Patients will continue to receive treatment with gemcitabine and R115777
(or placebo) unless disease progression or unacceptable toxicity is observed. All patients
in the study will be followed for study assessments and safety for up to the 5 years, the
start of further treatment, or death (whichever comes first). R115777 (or matching placebo)
200 mg will be orally administered at intervals of approximately 12 hours daily throughout
the study. Gemcitabine will be administered iv at a starting dose of 1000 mg/m2 every week
for the first 7 weeks, followed by 1 week rest, and then every 3 out of 4 weeks thereafter.
Treatment with gemcitabine and tipifarnib (or placebo) will continue for up to 5 years (or
until the start of further treatment) in the absence of disease progression or unacceptable
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Overall survival of patients with advanced pancreatic cancer after treatment with gemcitabine with or without R115777.
From the date of randomization to the date of death or to the last followup date for patients who were still alive at the clinical cutoff date (ie, for up to 5 years)
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
United States: Food and Drug Administration