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

Recurrent Non Small Cell Lung Cancer Clinical Trial

— TP2001-201  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00652340
• Other study ID #: TP2001-201
• Secondary ID: APRiCOT-L
• Status: Completed
• Phase: Phase 2
• First received: March 31, 2008
• Last updated: March 13, 2012
• Start date: April 2008
• Est. completion date: March 2012

Study information

• Verified date: March 2012
• Source: Tragara Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: March 2012
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Recurrent Non Small Cell Lung Cancer

Intervention

Drug:
• apricoxib/erlotinib
apricoxib: 100 mg tablets, 400mg/day erlotinib: per package insert
• erlotinib/placebo
erlotinib: per package insert placebo: 100 mg tablets, 400 mg/day

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tragara Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Disease Progression (TDP)		Baseline and every other cycle.	No
Secondary	Overall Survival		Randomization and every cycle	No