Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005648
Status:
COMPLETED
Last Update Posted:
2011-05-19
First Post:
2000-05-02
Brief Title:
Gemcitabine With or Without Tipifarnib R115777 in Treating Patients With Advanced Pancreatic Cancer
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
A Phase III Double-Blind Placebo Controlled Trial of Gemcitabine Plus Placebo Versus Gemcitabine Plus R115777 in Patients With Advanced Pancreatic Cancer
Status:
COMPLETED
Status Verified Date:
2010-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
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 mgm2 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R115777-INT-11 | None | None | None |