Ignite Creation Date:
2024-05-05 @ 6:39 PM
Last Modification Date:
2024-10-26 @ 9:36 AM
Study NCT ID:
NCT00529113
Status:
TERMINATED
Last Update Posted:
2024-02-02
First Post:
2007-09-12
Brief Title:
Study With Gemcitabine and RTA 402 for Patients With Unresectable Pancreatic Cancer
Sponsor:
Reata a wholly owned subsidiary of Biogen
Organization:
Biogen
Study Overview
Official Title:
A Randomized Phase III Study With Gemcitabine and RTA 402 or Gemcitabine and Placebo for Patients With Unresectable Pancreatic Cancer
Status:
TERMINATED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
To pursue other indications
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study assesses the safety and efficacy of RTA 402 in combination with gemcitabine in patients with unresectable pancreatic cancer
Detailed Description:
Phase I will be conducted to determine the MTD of RTA 402 administered orally Days 1-21 or Days 1-28 of a 28-day cycle in combination with gemcitabine 1000 mm2 Gemcitabine will be administered as an intravenous infusion on Days 1 8 and 15 of each 28-day cycle
The phase II portion of the study will be randomized and double-blinded Phase II will utilize the RTA 402 MTD determined in Phase I Arm 1 will consist of gemcitabine RTA 402 RTA 402 capsules will administered orally Days 1-21 of each 28-day cycle or Days 1-28 if appropriate based on phase I results gemcitabine 1000 mgm2 will be administered as an intravenous infusion on Days 1 8 and 15 of each 28-day cycle in each Arm Arm 2 will consist of gemcitabine placebo placebo capsules will be taken orally Days 1-21 of each 28-day cycle or Days 1-28 if appropriate based on phase I results Both treatment arms are 4-weeks in length
The study was conceived with both a Phase I and Phase II portion as described above however only the Phase I portion was completed The trial was terminated in 2009 before the Phase II portion could begin
Study Sponsor originally Reata Pharmaceuticals Inc is now Reata Pharmaceuticals Inc a wholly owned subsidiary of Biogen
The phase II portion of the study will be randomized and double-blinded Phase II will utilize the RTA 402 MTD determined in Phase I Arm 1 will consist of gemcitabine RTA 402 RTA 402 capsules will administered orally Days 1-21 of each 28-day cycle or Days 1-28 if appropriate based on phase I results gemcitabine 1000 mgm2 will be administered as an intravenous infusion on Days 1 8 and 15 of each 28-day cycle in each Arm Arm 2 will consist of gemcitabine placebo placebo capsules will be taken orally Days 1-21 of each 28-day cycle or Days 1-28 if appropriate based on phase I results Both treatment arms are 4-weeks in length
The study was conceived with both a Phase I and Phase II portion as described above however only the Phase I portion was completed The trial was terminated in 2009 before the Phase II portion could begin
Study Sponsor originally Reata Pharmaceuticals Inc is now Reata Pharmaceuticals Inc a wholly owned subsidiary of Biogen
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