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A Randomized Phase 2 Study of Ixabepilone Plus Carboplatin and Paclitaxel Plus Carboplatin in Advanced Nonsmall-Cell Lung Cancer

NCT00723957 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2020-10-28

Study results available
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Summary

The purpose of this study is to determine whether progression-free survival with ixabepilone is superior to that achieved with paclitaxel plus carboplatin in participants with advanced nonsmall-cell lung cancer and beta III (βIII)-tubulin-positive tumors.

Conditions

  • Advanced/Metastatic Non-Small Cell Lung Cancer

Interventions

DRUG

Ixabepilone, 32 mg/m^2

Intravenous (IV) solutions, ixabepilone, 32 mg/m\^2

DRUG

Paclitaxel, 200 mg/m^2

IV solutions, paclitaxel, 200 mg/m\^2

DRUG

Carboplatin (area under the concentration curve [AUC] 6)

Carboplatin (AUC 6) day 1, every 21 days, 6 cycles

Sponsors & Collaborators

  • R-Pharm

    lead INDUSTRY

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2010-05-31
Completion
2011-08-31

Countries

  • United States
  • Argentina
  • Australia
  • France
  • Germany
  • Italy
  • Russia
  • South Korea
  • Spain
  • Taiwan

Study Locations

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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 NCT00723957 on ClinicalTrials.gov