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Gemcitabine With or Without Tipifarnib (R115777) in Treating Patients With Advanced Pancreatic Cancer

NCT00005648 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 688

Last updated 2011-05-19

No results posted yet for this study

Summary

The purpose of this study is to compare the effectiveness of gemcitabine with or without tipifarnib (R115777) in patients who have advanced pancreatic cancer.

Conditions

  • Pancreatic Neoplasms

Interventions

DRUG

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 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

Sponsors & Collaborators

  • Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    lead INDUSTRY

Principal Investigators

  • Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial · Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1999-11-30
Completion
2003-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00005648 on ClinicalTrials.gov