CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 12 enrolled
Drug / intervention
Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/min/mL +1 moredrug
Likely dose
Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/min/mLfrom 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/NCT00683904
NCT00683904Phase 1Completed
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A Phase I Study of Ixabepilone in Combination With Carboplatin in Patients With Non-small Cell Lung Cancer as First-line Treatment

R-Pharm·interventional·Posted May 26, 2008·Updated Mar 10, 2016

In Brief

A Phase 1 clinical trial evaluating Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/min/mL and Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/min/mL for Non-small Cell Lung Cancer (NSCLC). Completed, enrolled 12 participants across 1 site.

Detailed Summary

The purpose of this study is to determine the maximum tolerated dose, dose-limiting toxicity, and recommended Phase II dose of ixabepilone in combination with carboplatin in patients with non-small cell lung cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-small Cell Lung Cancer (NSCLC)
CountriesJapan
Collaborators--

Timeline

Phase 1CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 26, 2008
Enrollment StartJun 1, 2008
Primary CompletionSep 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 18.1 years ago

Interventions

Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/min/mLdrug

On Day 1 of each 21-day cycle, ixabepilone, 32 mg/m\^2, intravenous (IV) solution administered as a 3-hour infusion; 30 minutes after the end of ixabepilone infusion, carboplatin, 5 mg/min/mL, intravenous IV solution infused over 30 minutes. Repeated once every 3 weeks, for a maximum of 6 cycles.

Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/min/mLdrug

After all participants in Dose Level 1 (ixabepilone, 32 mg/m\^2 + carboplatin, 5 mg/min/mL) have been observed for 1 full 21-day cycle, Dose Level 2(ixabepilone, 32 mg/m\^2 + carboplatin, 6 mg/min/mL) opened. On Day 1 of each 21-day cycle, ixabepilone, 32 mg/m\^2, IV solution administered as a 3-hour infusion; 30 minutes after the end of ixabepilone infusion, carboplatin, 6 mg/min/mL, IV solution infused over 30 minutes. Repeated once every 3 weeks, for a maximum of 6 cycles.