Randomized, Double-Blind, Placebo Controlled Study to Evaluate Efficacy and Safety of Apricoxib With Erlotinib in Patients With Non-Small Cell Lung Cancer - Full Text View

Randomized, Double-Blind, Placebo Controlled Study to Evaluate Efficacy and Safety of Apricoxib With Erlotinib in Patients With Non-Small Cell Lung Cancer (TP2001-201)

This study is currently recruiting participants.

Verified by Tragara Pharmaceuticals, Inc., June 2008

Sponsored by:	Tragara Pharmaceuticals, Inc.
Information provided by:	Tragara Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00652340

Purpose

This study will compare the anti-tumor efficacy of apricoxib and erlotinib with placebo and erlotinib as measured by time to disease progression to test the hypothesis that down regulation of COX-2 and EGFR pathways in patients with up-regulated COX-2 expression in tumor will have a clinical benefit compared with erlotinib alone.

Condition	Intervention	Phase
Recurrent Non Small Cell Lung Cancer	Drug: apricoxib/erlotinib Drug: erlotinib/placebo	Phase II

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Erlotinib Erlotinib hydrochloride

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-L (Apricoxib in Combination Oncology Treatment - Lung) A Randomized, Double-Blind, Placebo-Controlled Multicenter Phase 2 Study of the Efficacy and Safety of Apricoxib in Combination With Erlotinib in Non-Small Cell Lung Cancer Patients

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

Primary Outcome Measures:

to determine the anti-tumor activity of the combination of apricoxib and erolitinib compared with placebo and erlotinib as measured by time to disease progression. [ Time Frame: time to disease progression ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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

Estimated Enrollment:	115
Study Start Date:	April 2008
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

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

Eligibility

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

Criteria

Inclusion Criteria:

Pathologically determined Stage IV NSCLC
Failed one or more prior platinum based chemotherapy
Must have measurable disease by RECIST
Greater than or equal to 18 years of age

Exclusion Criteria:

Radiation within 2 weeks; chemotherapy or non-cytotoxic investigational agents within 4 weeks of initiating study treatment
Evidence of New York Heart Association class III or greater cardiac disease
History of MI, stroke, ventricular arrhythmia
Known HIV infection or AIDS
Symptomatic CNS metastases
Pregnant or nursing women
History of GI bleed, ulceration or perforation
Previous anti-EGFR kinase therapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00652340

Contacts

Contact: Karen Kuhn

kkuhn@ockham.com

Show 35 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, MD )
Study ID Numbers:	TP2001-201, APRiCOT-L
Study First Received:	March 31, 2008
Last Updated:	June 25, 2008
ClinicalTrials.gov Identifier:	NCT00652340
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Erlotinib
Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases
Lung Neoplasms

Lung Diseases
Carcinoma, Non-Small-Cell Lung
Recurrence
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009