Clinical trial NCT00322374: Phase I Combination w/ Epirubicin
Official title: A Phase I Study of Ixabepilone in Combination With Epirubicin in Patients With Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Metastatic Breast Cancer
Lead sponsor: R-Pharm
Sponsor class: INDUSTRY
First posted: 2006-05-05
Enrollment: 42
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Women ≥18 years
* Histologically or cytologically confirmed diagnosis of metastatic breast cancer
* Measurable or nonmeasurable disease defined by Response Evaluation Criteria In Solid Tumors (RECIST)

Exclusion Criteria:

* Number of prior chemotherapy lines of treatment in the metastatic setting ≥2

Primary outcomes:
measure: Number of Participants With a Dose Limiting Toxicity (DLT)
timeFrame: From Baseline to the end of Cycle 1 (Day 21)
measure: Ixabepilone Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (R2PD)
timeFrame: Day 21 of Cycle 1
Secondary outcomes:
measure: Number of Participants With Death, Adverse Events (AEs), Serious Adverse Events (SAEs), Grade 3/4 AEs, or AEs Leading to Discontinuation
timeFrame: Evaluated continuously on study from Baseline to ≤30 days after the last dose of study drug.
measure: Maximum Plasma Concentration (Cmax) of Single-dose Ixabepilone
timeFrame: From the start of the ixabepilone infusion on Day 1 to 120 hours after the first infusion.
measure: Area Under the Curve, Extrapolated to Infinity (AUC[INF]) of Single-dose Ixabepilone
timeFrame: From the start of the ixabepilone infusion on Day 1 to 120 hours after the first infusion.
measure: Terminal Half-life (T-Half) of Single-dose Ixabepilone
timeFrame: From the start of the ixabepilone infusion on Day 1 to 120 hours after the first infusion.
measure: Clearance (CLT) of Single-dose Ixabepilone
timeFrame: From the start of the ixabepilone infusion on Day 1 to 120 hours after the first infusion.
measure: Volume of Distribution at Steady State (Vss) of Single-dose Ixabepilone
timeFrame: From the start of the ixabepilone infusion on Day 1 to 120 hours after the first infusion.
measure: Epirubicin Cmax
timeFrame: From the start of the ixabepilone infusion on Day 1 to 24 hours after the first infusion.
measure: Epirubicin AUC(INF)
timeFrame: From the start of the ixabepilone infusion on Day 1 to 24 hours after the first infusion.
measure: Epirubicin T-Half
timeFrame: From the start of the ixabepilone infusion on Day 1 to 24 hours after the first infusion.
measure: Epirubicin CLT
timeFrame: From the start of the ixabepilone infusion on Day 1 to 24 hours after the first infusion.
measure: Epirubicin Vss
timeFrame: From the start of the ixabepilone infusion on Day 1 to 24 hours after the first infusion.
measure: Number Of Participants With A Best Overall Tumor Response of Complete Response, Partial Response, Stable Disease, And Progressive Disease
timeFrame: From Baseline (up to 2 weeks prior to starting therapy) to the end Cycle 2
measure: Duration of Tumor Response
timeFrame: Time (in months) when criteria for CR or PR are met (which ever occurs first) up to date of progressive disease.
measure: Number Of Participants With Tumor Response by Duration of Response Category
timeFrame: Time (in months) when criteria for CR or PR are met (which ever occurs first) up to date of progressive disease.
Other outcomes:
Locations:
city: Toulouse Cedex 3
country: France
facility: Local Institution
city: Milano
country: Italy
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: