CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 109 enrolled
Drug / intervention
apricoxib +2 moredrug
Likely dose
apricoxib 100mgfrom 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.

Search/NCT00771953
NCT00771953Phase 2Completed
CompareCT.gov

0822GCC Randomized, Double-Blind, Placebo-Controlled Multicenter Phase 2 Study of the Efficacy and Safety of Apricoxib in Combination With Either Docetaxel or Pemetrexed in Non-Small Cell Lung Cancer Patients

University of Maryland, Baltimore·interventional·Posted Oct 15, 2008·Updated Oct 30, 2019

In Brief

A Phase 2 clinical trial evaluating apricoxib, Placebo, and 1 other intervention for Lung Cancer and Non Small Cell Lung Cancer. Completed, enrolled 109 participants across 12 sites.

Detailed Summary

The primary objective is to determine the anti-tumor activity of the combination of apricoxib + either docetaxel (AP/DC) or pemetrexed (AP/PE) compared with placebo + either docetaxel (P/DC) or pemetrexed (P/PE) as measured by progression free survival in patients with Stage IIIb (pleural effusion)or Stage IV non-small cell lung cancer (NSCLC).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLung Cancer, Non Small Cell Lung Cancer
CountriesUnited States
CollaboratorsTragara Pharmaceuticals, Inc.

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 15, 2008
Enrollment StartNov 1, 2008
Primary CompletionMay 1, 2012
Study CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 17.7 years ago

Interventions

apricoxibdrug

Oral apricoxib tablets will be provided as white or off-white film-coated tablets available in 100mg strength to be taken every day

Placebodrug

Oral placebo tablets will be provided as white or off-white film-coated tablets to be taken every day

Docetaxel or Pemetrexeddrug

Docetaxel 75mg/m2 or Pemetrexed 500mg/m2 given as an IV infusion every 21 days. TheTreating physician will determine chemotherapy drug as per his usual practice.