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
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Recurrent Non Small Cell Lung Cancer
Both
Recurrent Non Small Cell Lung Cancer
Trial Information
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
Inclusion Criteria:
- Pathologically determined Stage IV NSCLC including Stage IIIb (pleural effusion)
- Failed at least one prior platinum-based chemotherapy for Stage IIIb or Stage IV
NSCLC. Patients receiving platinum-based chemotherapy only given in an adjuvant
setting are not eligible.
- Measurable disease by RECIST
- Greater than or equal to 18 years of age
- ECOG PS of 0 or 1
Exclusion Criteria:
- Radiation therapy within 2 weeks; chemotherapy within 3 weeks; non-cytotoxic
investigational agents within 4 weeks of initiating study treatment
- Evidence of NYHA class III or greater cardiac disease
- History of MI, stroke, ventricular arrhythmia, or symptomatic conduction abnormality
within 12 months
- Known HIV infection or AIDS
- Symptomatic CNS metastases
- Pregnant or nursing women
- Hypersensitivity or intolerance to erlotinib, sulfonamides, aspirin, or other NSAIDs.
- History of upper GI bleeding, ulceration, or perforation
- Prior history of COX-2 inhibitor therapy for the treatment of metastatic NSCLC
- Previous anti-EGFR kinase therapy
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Time to Disease Progression (TDP)
Outcome Time Frame:
Baseline and every other cycle.
Safety Issue:
No
Principal Investigator
Tracy Parrott
Investigator Role:
Study Director
Investigator Affiliation:
Tragara Pharmaceuticals, Inc.
Authority:
United States: Food and Drug Administration
Study ID:
TP2001-201
NCT ID:
NCT00652340
Start Date:
April 2008
Completion Date:
March 2012
Related Keywords:
- Recurrent Non Small Cell Lung Cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|---|
| Hinsdale, Illinois 60521 | |
| New Britain, Connecticut 06052 | |
| Bettendorf, Iowa 52722 | |
| Alexandria, Minnesota 56308 | |
| Albany, Georgia 31701 | |
| Phoenix, Arizona 85012 | |
| Fountain Valley, California 92708 | |
| Miami, Florida 33176 | |
| Columbia, Missouri 65203 | |
| Albany, New York 12208 | |
| Cleveland, Ohio 44195 | |
| Philadelphia, Pennsylvania 19104 | |
| Austin, Texas 78705 | |
| Seattle, Washington 98195 | |
| Flint, Michigan 48532 | |
| Louisville, Kentucky 40207 | |
| McLean, Virginia 22101 | |
| Hackensack, New Jersey 07601 | |
| Metairie, Louisiana 70006 | |
| Charlotte, North Carolina | |
| Eugene, Oregon | |
| Indianapolis, Indiana | |
| Charleston, South Carolina | |
| Charleston, West Virginia 25304 |
