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

Conditions

• Recurrent Non Small Cell Lung Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed

Apr 3, 2008

Start date

Apr 30, 2008

Status verified

Mar 2012

Primary completion

Jun 30, 2010

Completion

Mar 31, 2012

Study Design

Enrollment

120 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: A
• Placebo Comparator: B

Primary Outcome Measure

Time to Disease Progression (TDP) [ Time Frame: Baseline and every other cycle. ]

Locations (47)

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