APRiCOT-L: Study to Evaluate Efficacy and Safety of Apricoxib With Erlotinib in Patients With Non-small Cell Lung Cancer (TP2001-201)

Tragara Pharmaceuticals

Status and phase

Completed

Phase 2

Conditions

Recurrent Non Small Cell Lung Cancer

Treatments

Drug: apricoxib/erlotinib

Drug: erlotinib/placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00652340

TP2001-201

APRiCOT-L

Details and patient eligibility

About

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.

Enrollment

120 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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