At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 120 enrolled
Drug / intervention
apricoxib/erlotinib +1 moredrug
Likely dose
apricoxib/erlotinib 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating apricoxib/erlotinib and erlotinib/placebo for Recurrent Non Small Cell Lung Cancer. Completed, enrolled 120 participants across 47 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRecurrent Non Small Cell Lung Cancer
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartApr 2008
First PostedApr 2008
Primary CompletionJun 2010
Study CompletionMar 2012
TodayJul 2026
First PostedApr 3, 2008
Enrollment StartApr 1, 2008
Primary CompletionJun 1, 2010
Study CompletionMar 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 18.2 years ago
Interventions
apricoxib/erlotinibdrug
apricoxib: 100 mg tablets, 400mg/day erlotinib: per package insert
erlotinib/placebodrug
erlotinib: per package insert placebo: 100 mg tablets, 400 mg/day