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Phase I Combination Ixabepilone + Cisplatin

NCT00832117 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2020-10-28

Study results available
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Summary

The purpose of this study is to determine the highest dose of ixabepilone that can be given safely with cisplatin without causing severe or life-threatening side effects and for some patients with non-small cell lung cancer, the effects (good or bad) on your cancer will also be studied

Conditions

  • Non Small Cell Lung Cancer

Interventions

DRUG

Ixabepilone

Escalation: Solution, intravenous (IV), 32-40 mg/m2, every 3 weeks, approximately 6 months

DRUG

Cisplatin

Escalation: Solution, IV, 60-100 mg/m2, every 3 weeks, approximately 6 months

DRUG

Ixabepilone

Expansion: Solution, IV, 32 mg/m2, every 3 weeks, approximately 6 months

DRUG

Cisplatin

Expansion: Solution, IV, 60-80 mg/m2, every 3 weeks, approximately 6 months

Sponsors & Collaborators

  • R-Pharm

    lead INDUSTRY

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2011-01-31
Completion
2011-01-31

Countries

  • United States
  • Italy

Study Locations

More Related Trials

Entities

Drugs

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 NCT00832117 on ClinicalTrials.gov