MedTrace Logo

Ixabepilone in Combination With Carboplatin in Patients With Non-small Cell Lung Cancer

NCT00683904 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2016-03-10

Study results available
· View outcomes & findings →

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.

Conditions

  • Non-small Cell Lung Cancer (NSCLC)

Interventions

DRUG

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

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.

DRUG

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

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.

Sponsors & Collaborators

  • R-Pharm

    lead INDUSTRY

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2009-09-30
Completion
2009-09-30

Countries

  • Japan

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00683904 on ClinicalTrials.gov