CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 218 enrolled
Drug / intervention
enzastaurin +3 moredrug
Likely dose
enzastaurin 1200 milligramsfrom 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/NCT00308750
NCT00308750Phase 2Completed
CompareCT.gov

A Randomized, Open-label Phase II Study of Pemetrexed (Alimta) Plus Carboplatin With or Without Enzastaurin Hydrochloride, or Docetaxel Plus Carboplatin as First Line Treatment in Patients With Advanced Stage Non-small Cell Lung Cancer (NSCLC)

Eli Lilly and Company·interventional·Posted Mar 30, 2006·Updated May 13, 2021

In Brief

A Phase 2 clinical trial evaluating enzastaurin, pemetrexed, and 2 other interventions for Non-Small Cell Lung Cancer. Completed, enrolled 218 participants across 4 sites.

Detailed Summary

The purposes of this study are to determine: The safety of enzastaurin plus pemetrexed with carboplatin, pemetrexed with carboplatin, or docetaxel with carboplatin and any side effects that might be associated with the combination of these drugs. Whether the combination of enzastaurin plus pemetrexed and carboplatin or pemetrexed and carboplatin can help participants with non-small cell lung cancer (NSCLC) live longer, compared with the combination of docetaxel and carboplatin. Whether the combination of enzastaurin plus pemetrexed and carboplatin or pemetrexed and carboplatin can make your tumor smaller or disappear, and for how long, compared with the combination of docetaxel and carboplatin. The effects of enzastaurin plus pemetrexed with carboplatin, pemetrexed with carboplatin or docetaxel with carboplatin have on your disease related symptoms. The relation of smoking history and hormone replacement therapy (for women only) may have to your lung cancer treatment results. The effects of certain genes and proteins in samples of your blood and tumor tissue in order to learn more about NSCLC and how enzastaurin works in the body.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-Small Cell Lung Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 30, 2006
Enrollment StartMar 1, 2006
Primary CompletionJul 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 20.3 years ago

Interventions

enzastaurindrug

1125-1200 milligrams (mg) loading dose then 500 mg, oral, daily, until disease progression

pemetrexeddrug

500 milligrams per square meter (mg/m\^2), intravenous (IV), once every (q) 21 days, six 21 day cycles or progressive disease

docetaxeldrug

75 mg/m\^2, IV, q 21 days, six 21 day cycles or progressive disease

carboplatindrug

Area under the curve (AUC) 6, IV, q 21 days, six 21 day cycles or progressive disease