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

Breast Cancer Clinical Trial

Official title:

A Phase I Study of Ixabepilone in Combination With Capecitabine in Japanese Patients With Metastatic Breast Cancer Previously Treated With an Anthracycline and a Taxane

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00568022
• Other study ID #: CA163-117
• Status: Completed
• Phase: Phase 1
• First received: December 3, 2007
• Last updated: February 9, 2016
• Start date: February 2008
• Est. completion date: January 2010

Study information

• Verified date: February 2016
• Source: R-Pharm
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Ixabepilone
Ixabepilone: Intravenous (IV) Solution, IV, 32(40)mg/m^2, once every 3 weeks, up to 6 cycles
• Capecitabine
Capecitabine: Tablets, Oral, 1650(2000)mg/m^2, twice daily for 2 weeks, one week off, up to 6 cycles

Locations

Country	Name	City	State
Japan	Local Institution	Maebashi-Shi	Gunma
Japan	Local Institution	Matsuyama-Shi	Ehime
Japan	Local Institution	Osaka
Japan	Local Institution	Sunto-Gun	Shizuoka

Sponsors (1)

Lead Sponsor	Collaborator
R-Pharm

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participants Experiencing Dose Limiting Toxicity (DLT)	DLT was defined as any ixabepilone and/or capecitabine related events requiring study discontinuation during the first two treatment cycles.	From initiation of drug through last day of Cycle 2 (Day 42)	Yes
Primary	Participants Achieving the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D)	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.	At the end of Cycle 2 (Day 42)	No
Secondary	Adverse Events (AEs) and Serious Adverse Events (SAEs)	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	Baseline to Day 42, continuously	Yes
Secondary	Participant Tumor Response at Study Endpoint	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.	At baseline and after every 42 days (every 2 21-day cycles) after baseline	No
Secondary	Mean Ixabepilone Maximum Plasma Concentration (Cmax) in One Dosing Interval	Cmax = maximum observed plasma concentration of ixabepilone as determined from participant serum samples in one dosing interval.	During Cycle 1 at specified timepoints (Day 1 to Day 8).	No
Secondary	Mean Ixabepilone Area Under the Concentration Curve (AUC INF) in One Dosing Interval	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.	During Cycle 1 at specified timepoints (Day 1 to Day 8).	No
Secondary	Mean Ixabepilone Terminal Elimination Half Life (T 1/2) in One Dosing Interval	T 1/2 = terminal elimination half life as determined from participant serum samples in one dosing interval.	During Cycle 1 at specified timepoints (Day 1 to Day 8).	No
Secondary	Mean Ixabepilone Volume of Distribution at Steady State (Vss) in One Dosing Interval	Vss = volume of distribution at steady state determined from participant serum samples from one dosing interval.	During Cycle 1 at specified timepoints (Day 1 to Day 8).	No
Secondary	Mean Ixabepilone Total Body Clearance (CLT) in One Dosing Interval	CLT = total body clearance as determined from participant serum samples in one dosing interval.	During Cycle 1 at specified timepoints (Day 1 to Day 8).	No

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   Investigator Inquiry form