Study to Evaluate the Safety and Efficacy of Apricoxib With Gemcitabine and Erlotinib in the Treatment of Patients With Advanced Pancreatic Cancer (TP2001-203) - Full Text View

Sponsored by:	Tragara Pharmaceuticals, Inc.
Information provided by:	Tragara Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00709826

Purpose

This study will compare the anti-tumor efficacy of apricoxib and gemcitabine/erlotinib with placebo and gemcitabine/erlotinib as measured by time to tumor progression 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.

Condition	Intervention	Phase
Advanced Pancreatic Cancer Metastatic Pancreatic Cancer	Drug: apricoxib + gemcitabine + erlotinib Drug: placebo + gemcitabine + erlotinib	Phase II

MedlinePlus related topics: Cancer Pancreatic Cancer

Drug Information available for: Gemcitabine hydrochloride Gemcitabine Erlotinib Erlotinib hydrochloride Pancrelipase Ultrase

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title:	APRiCOT-P (Apricoxib in Combination Oncology Treatment - Pancreas): A Randomized Placebo-Controlled Multicenter Phase 2 Study of the Efficacy and Safety of Apricoxib in Combination With Gemcitabine and Erlotinib in the Treatment of Patients With Advanced Pancreatic Cancer.

Further study details as provided by Tragara Pharmaceuticals, Inc.:

Primary Outcome Measures:

To determine the anti-tumor activity of the combination of apricoxib and gemcitabine/erlotinib compared with placebo and gemcitabine/erlotinib. [ Time Frame: Time to tumor progression. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Progression free survival, overall survival and safety/tolerability. [ Time Frame: Time to tumor progression ] [ Designated as safety issue: No ]

Estimated Enrollment:	80
Study Start Date:	August 2008
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental apricoxib + gemcitabine+ erlotinib	Drug: apricoxib + gemcitabine + erlotinib apricoxib: 100 mg tablets, 400 mg/day Gemcitabine: per package insert. erlotinib: per package insert.
B: Placebo Comparator placebo + gemcitabine + erlotinib	Drug: placebo + gemcitabine + erlotinib placebo: 100 mg tablets, 400 mg/day gemcitabine: per package insert. erlotinib: per package insert.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologically or cytologically confirmed adenocarcinoma of the pancreas that is locally advanced or metastatic.
Life expectancy greater than or equal to 3 months.
Patients must have measurable disease by RECIST.
ECOG PS of 0, 1, or 2.
Negative serum pregnancy test at the time of first dose for women of childbearing potential.

Exclusion Criteria:

RT within 2 weeks or chemotherapy within 3 weeks or noncytotoxic investigational agents within 4 weeks of initiating study treatment.
Evidence of New York Heart Association class III or greater cardiac disease.
History of myocardial infarction, stroke, ventricular arrhythmia.
Symptomatic central nervous system metastases.
Pregnant or nursing women.
Hypersensitivity or intolerance to apricoxib, erlotinib, gemcitabine, sulfonamides, aspirin, or other non-steroidal anti-inflammatory drugs (NSAIDs).
History of upper gastrointestinal bleeding, ulceration or perforation.
Previous anti-EGFR kinase therapy.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00709826

Contacts

Contact: Karen Kuhn

kkuhn@ockham.com

Show 22 Study Locations

Sponsors and Collaborators

Tragara Pharmaceuticals, Inc.

Investigators

Study Director:

Sara Zaknoen, M.D.

Tragara Pharmaceuticals, Inc.

More Information

Responsible Party:	Tragara Pharmaceuticals Inc. ( Sara Zaknoen, M.D. )
Study ID Numbers:	TP2001-203, APRiCOT-P
Study First Received:	July 1, 2008
Last Updated:	November 3, 2008
ClinicalTrials.gov Identifier:	NCT00709826
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Erlotinib
Digestive System Diseases
Digestive System Neoplasms
Pancreatic Neoplasms
Endocrine System Diseases
Pancreatic Diseases

Gastrointestinal Neoplasms
Endocrinopathy
Gemcitabine
Pancrelipase
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors

Protein Kinase Inhibitors
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on January 14, 2009