CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,052 enrolled
Drug / intervention
Albumin-bound paclitaxel +2 moredrug
Likely dose
Not stated in 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/NCT00540514
NCT00540514Phase 3Completed
CompareCT.gov

A Randomized, Phase III Trial of ABI-007 and Carboplatin Compared With Taxol and Carboplatin as First-Line Therapy in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

Celgene·interventional·Posted Oct 8, 2007·Updated Oct 29, 2019

In Brief

A Phase 3 clinical trial evaluating Albumin-bound paclitaxel, Paclitaxel, and 1 other intervention for Non-Small Cell Lung Carcinoma. Completed, enrolled 1,052 participants across 37 sites in 2 countries.

Detailed Summary

The purpose of this study is to compare disease response of Albumin-bound paclitaxel (ABI-007) plus Carboplatin versus Taxol and Carboplatin as first-line therapy in patients with advanced non-small cell lung cancer (NSCLC).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-Small Cell Lung Carcinoma
CountriesCanada, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 8, 2007
Enrollment StartNov 1, 2007
Primary CompletionOct 1, 2009
Study CompletionFeb 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 18.7 years ago

Interventions

Albumin-bound paclitaxeldrug

Administered by intravenous infusion.

Paclitaxeldrug

Administered by intravenous infusion.

Carboplatindrug

Administered by intravenous infusion. Dosing was based on the Calvert formula: carboplatin dose (mg) = (Target AUC) x (glomerular filtration rate \[GFR\] + 25). For the purposes of this protocol, the GFR is considered to be equivalent to creatinine clearance (calculated by the method of Cockcroft and Gault, 1976).