CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 33 enrolled
Drug / intervention
pemetrexeddrug
Likely dose
pemetrexed 500 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/NCT00380718
NCT00380718Phase 4Completed

Open-Label Single-Arm Phase IV Study of Pemetrexed in Taiwanese Patients With Advanced Non-Small Cell Lung Cancer Who Have Had Prior Chemotherapy

Eli Lilly and Company·interventional·Posted Sep 26, 2006·Updated Nov 16, 2010

In Brief

A Phase 4 clinical trial evaluating pemetrexed for Non-small Cell Lung Cancer. Completed, enrolled 33 participants across 2 sites.

Detailed Summary

The purpose of this study is to assess the efficacy and toxicity of pemetrexed dosing that is tailored to individual patient tolerance in patients with advanced non-small cell lung cancer (NSCLC).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesTaiwan
Collaborators--

Timeline

Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 26, 2006
Enrollment StartNov 1, 2006
Primary CompletionSep 1, 2008
Study CompletionNov 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 19.8 years ago

Interventions

pemetrexeddrug

500 milligrams per square meter (mg/m2), intravenous (IV) in the first cycle. Acceptable toxicity\* in cycle 1 determines dose increase to 1000 mg/m2 or dose decrease to 375 mg/m2 with unacceptable toxicity every 3 week in subsequent cycles till progression of disease. \*Toxicity acceptable if none of the following toxicities recorded at any time during Cycle 1: Platelets \<50 x 10\^9/L; absolute neutrophil count \<1.0 x 10\^9/L; Stomatitis/pharyngitis/esophagitis/diarrhea Grade \>2; Skin Grade \>2; Serum bilirubin \>3.0 x upper limit of normal (ULN); alanine aminotransferase/aspartate aminotransferase \>10 x ULN; Other non-hematologic toxicities Grade \>2 (except nausea, vomiting).