2008-08
2010-06
2011-05
109
NCT00709826
Tragara Pharmaceuticals, Inc.
Tragara Pharmaceuticals, Inc.
INTERVENTIONAL
APRiCOT-P: Study of Apricoxib With Gemcitabine and Erlotinib to Treat Advanced Pancreatic Cancer
This study will compare the anti-tumor efficacy of apricoxib and gemcitabine/erlotinib with placebo and gemcitabine/erlotinib in patients with advanced pancreatic cancer.
This study will compare the anti-tumor efficacy of apricoxib and gemcitabine/erlotinib with placebo and gemcitabine/erlotinib as measured by progression-free survival to test the hypothesis that down regulation of COX-2 and EGFR pathways in patients with up-regulated COX-2 expression in tumors will have a clinical benefit compared with Gemcitabine/Erlotinib only.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2008-07-01 | 2012-06-18 | 2012-10-08 |
2008-07-02 | 2012-10-08 | 2012-11-07 |
2008-07-03 | 2012-11-07 | 2012-10 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
Quadruple
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: apricoxib + gemcitabine + erlotinib 400mg apricoxib + 1000mg/m2 gemcitabine + 100mg erlotinib | DRUG: gemcitabine
DRUG: Erlotinib
DRUG: apricoxib
|
| PLACEBO_COMPARATOR: placebo + gemcitabine + erlotinib placebo + 1000mg/m2 gemcitabine + 100mg erlotinib | DRUG: gemcitabine
DRUG: placebo
DRUG: Erlotinib
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Progression Free Survival | Progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline. | Randomization then every other cycle |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Overall Survival | Randomization then every other cycle |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
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