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

Phase 1

Completed

• Conditions: Breast Cancer
• Interventions: Drug: Ixabepilone; Drug: Capecitabine

• Registration Number: NCT00568022
• Lead Sponsor: R-Pharm

Brief Summary

The purpose of this study is to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) and recommended Phase II dose of ixabepilone in combination with capecitabine in Japanese participants with metastatic breast cancer.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-12-03
• Study First Submitted QC: 2007-12-04
• Study First Posted: 2007-12-05
• Study Start: 2008-02
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Results First Submitted: 2011-06-03
• Results First Submitted QC: 2011-07-21
• Results First Posted: 2011-08-17
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-09
• Last Update Posted: 2016-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 9

Inclusion Criteria

• Women ≥ 20 years
• Histologically or cytologically confirmed diagnosis of adenocarcinoma originating in the breast

Exclusion Criteria

• Number of prior chemotherapy lines of treatment in the metastatic setting ≥3

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ixabepilone + Capecitabine	Ixabepilone	-
Ixabepilone + Capecitabine	Capecitabine	-

Primary Outcome Measures

Name	Time	Method
Participants Experiencing Dose Limiting Toxicity (DLT)	From initiation of drug through last day of Cycle 2 (Day 42)	DLT was defined as any ixabepilone and/or capecitabine related events requiring study discontinuation during the first two treatment cycles.
Participants Achieving the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D)	At the end of Cycle 2 (Day 42)	The MTD was defined as the highest dose evaluated for which less than 1/3 of the participants experienced DLT during the first two treatment cycles. If toxicities (e.g. hand-foot syndrome, existing peripheral neuropathy, etc.) occurred or became more severe in later cycles, the recommended Phase II dose was to be determined after due consideration of their severity.

Secondary Outcome Measures

Name	Time	Method
Adverse Events (AEs) and Serious Adverse Events (SAEs)	Baseline to Day 42, continuously	AE = any new untoward medical occurrence/worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE = any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. Treatment-related=Possible, Probable, or Certain relationship to drug
Participant Tumor Response at Study Endpoint	At baseline and after every 42 days (every 2 21-day cycles) after baseline	Tumor response was assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) in which complete response (CR) = disappearance of all target lesions; partial response (PR) = 30% decrease in the sum of the longest diameter of target lesions; progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions; and stable disease (SD) = small changes that do not meet above criteria.
Mean Ixabepilone Maximum Plasma Concentration (Cmax) in One Dosing Interval	During Cycle 1 at specified timepoints (Day 1 to Day 8).	Cmax = maximum observed plasma concentration of ixabepilone as determined from participant serum samples in one dosing interval.
Mean Ixabepilone Area Under the Concentration Curve (AUC INF) in One Dosing Interval	During Cycle 1 at specified timepoints (Day 1 to Day 8).	AUC = the average area under the concentration curve (AUC \[INF\]) of ixabepilone as determined from participant serum samples in one dosing interval over 24 hours.
Mean Ixabepilone Terminal Elimination Half Life (T 1/2) in One Dosing Interval	During Cycle 1 at specified timepoints (Day 1 to Day 8).	T 1/2 = terminal elimination half life as determined from participant serum samples in one dosing interval.
Mean Ixabepilone Volume of Distribution at Steady State (Vss) in One Dosing Interval	During Cycle 1 at specified timepoints (Day 1 to Day 8).	Vss = volume of distribution at steady state determined from participant serum samples from one dosing interval.
Mean Ixabepilone Total Body Clearance (CLT) in One Dosing Interval	During Cycle 1 at specified timepoints (Day 1 to Day 8).	CLT = total body clearance as determined from participant serum samples in one dosing interval.

Trial Locations

Locations (1)

Local Institution; 🇯🇵 Osaka, Japan