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Phase I Combination w/ Epirubicin

NCT00322374 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2016-03-10

Study results available
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Summary

Tumor response information was obtained for all participants who received at least 2 cycles of study drug, underwent requisite baseline and on-treatment disease assessments and had at least one post-treatment assessment. Tumor response assessment in evaluable participants was done according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.

Conditions

Interventions

DRUG

Ixabepilone

Infusion, intravenous (IV), Cycle = 21 days. Dose escalation study.

DRUG

Epirubicin

Infusion, intravenous (IV): 75 mg/m\^2. Cycle = 21 days, up to 10 cycles or cumulative dose of 800 mg/m².

Sponsors & Collaborators

  • R-Pharm

    lead INDUSTRY

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-08-31
Primary Completion
2009-02-28
Completion
2009-02-28

Countries

  • France
  • Italy

Study Locations

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Entities

Diseases

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 NCT00322374 on ClinicalTrials.gov