A Phase 3 interventional study of Gemcitabine with R115777 and Gemcitabine with Placebo in Pancreatic Neoplasms, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-05-19.
Sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · Phase 3, Interventional, and Treatment
The purpose of this study is to compare the effectiveness of gemcitabine with or without tipifarnib (R115777) in patients who have 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 toxicity.
3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.
This study's enrollment of 688 is above the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →Johnson & Johnson Pharmaceutical Research & Development, L.L.C. is the lead sponsor of 458 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Gemcitabine with R115777 R115777 200 mg oral twice daily at 12-hour intervals throughout the study coadministered with gemcitabine 1000 mg/m2 iv every week for the first 7 weeks followed by 1 week rest and then every 3 out of 4 weeks thereafter for up to 5 years
Drug: Gemcitabine with R115777
Gemcitabine with Placebo Placebo oral twice daily at 12-hour intervals throughout the study coadministered with gemcitabine 1000 mg/m2 iv every week for the first 7 weeks followed by 1 week rest and then every 3 out of 4 weeks thereafter for up to 5 years
Drug: Gemcitabine with Placebo
R115777 200 mg, oral, twice daily at 12-hour intervals throughout the study coadministered with gemcitabine, 1000 mg/m2, iv, every week for the first 7 weeks, followed by 1 week rest, and then every 3 out of 4 weeks thereafter for up to 5 years
Placebo, oral, twice daily at 12-hour intervals throughout the study coadministered with gemcitabine, 1000 mg/m2, iv, every week for the first 7 weeks, followed by 1 week rest, and then every 3 out of 4 weeks thereafter for up to 5 years
Overall survival of patients with advanced pancreatic cancer after treatment with gemcitabine with or without R115777.
Time frame: 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)
Evaluation of Quality of Life (QOL) parameters in patients with advanced pancreatic cancer after treatment with gemcitabine with or without R115777
Time frame: 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)
The incidence of adverse events with respect to severity and relationship to the study medication as a measure of safety
Time frame: 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)
No study locations are listed for this record.
This study is completed, as verified in Oct 2010. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.