CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 143 enrolled
Drug / intervention
pemetrexed +2 moredrug
Likely dose
pemetrexed 500 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.

Search/NCT00824408
NCT00824408Phase 2Completed
CompareCT.gov

A Randomised Open-label Phase II Trial of BI 6727 Monotherapy and BI 6727 in Combination With Standard Dose Pemetrexed Compared to Pemetrexed Monotherapy in Second Line Non-small Cell Lung Cancer

Boehringer Ingelheim·interventional·Posted Jan 16, 2009·Updated Sep 20, 2016

In Brief

A Phase 2 clinical trial evaluating pemetrexed and BI 6727 for Carcinoma, Non-Small-Cell Lung. Completed, enrolled 143 participants across 12 sites in 2 countries.

Detailed Summary

The trial objective will be to evaluate whether BI 6727 monotherapy or in combination with pemetrexed may be effective in the treatment of advanced or metastatic NSCLC in patients who relapsed after or failed first-line platinum based therapy. The secondary objectives are to identify the acceptable dose of BI 6727 in combination with pemetrexed and to characterize the pharmacokinetic profiles of BI 6727 alone. Arm A, BI6727 monotherapy arm is closed to further recruitment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarcinoma, Non-Small-Cell Lung
CountriesCanada, The Bahamas
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 16, 2009
Enrollment StartMar 1, 2009
Primary CompletionSep 1, 2012
Study CompletionAug 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 17.5 years ago

Interventions

pemetrexeddrug

500 mg/m\^2 i.v. on day 1 of 21 day cycle

pemetrexeddrug

500 mg/m\^2 i.v. on day 1 of 21 day cycle

BI 6727drug

BI 6727 i.v. on day 1 of a 21 day cycle