CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 42 enrolled
Drug / intervention
Ixabepilone +1 moredrug
Likely dose
Epirubicin 75 mgfrom 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/NCT00322374
NCT00322374Phase 1Completed
CompareCT.gov

A Phase I Study of Ixabepilone in Combination With Epirubicin in Patients With Metastatic Breast Cancer

R-Pharm·interventional·Posted May 5, 2006·Updated Mar 10, 2016

In Brief

A Phase 1 clinical trial evaluating Ixabepilone and Epirubicin for Metastatic Breast Cancer. Completed, enrolled 42 participants across 2 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Breast Cancer
CountriesFrance, Italy
Collaborators--

Timeline

Phase 1CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 5, 2006
Enrollment StartAug 1, 2006
Primary CompletionFeb 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 20.2 years ago

Interventions

Ixabepilonedrug

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

Epirubicindrug

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