Clinical trial NCT01027208: A Rollover Study of Ixabepilone (BMS-247550) In Patients With Metastatic Breast Cancer Previously Treated With An Anthracycline
Official title: A Rollover Study of Ixabepilone (BMS-247550) In Patients With Metastatic Breast Cancer Previously Treated With An Anthracycline And Who Are Taxane Resistant Who Have Completed Study CA163107 And Who Are Benefiting From Continuation On Therapy With Ixabepilone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Breast Cancer
Lead sponsor: R-Pharm
Sponsor class: INDUSTRY
First posted: 2009-12-07
Enrollment: 20
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To provide extended access to Ixabepilone therapy to subjects with metastatic breast cancer who have completed the previous Phase II study (CA163-107)


Eligibility criteria: Inclusion Criteria:

* Women aged 20 years or older
* Patients with metastatic breast cancer whose primary lesion was definitely diagnosed to be breast by histological or cellular examination

Exclusion Criteria:

* Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≥2

Primary outcomes:
measure: Provide extended access to Ixabepilone therapy to subjects with metastatic breast cancer who have completed the previous Phase II study (CA163107) and are benefiting from continuation on therapy with Ixabepilone as determined by the treating investigator
timeFrame: 21-day cycles until documented disease progression or unacceptable toxicity
measure: To evaluate the frequency and the severity of observed adverse reactions in treated patients, graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
timeFrame: 21-day cycles until documented disease progression or unacceptable toxicity
Secondary outcomes:
measure: Secondary objectives will be assessed by combining data with the previous Phase II study CA163107
timeFrame: 21-day cycles until documented disease progression or unacceptable toxicity
measure: To evaluate the antitumor response according to the RECIST criteria
timeFrame: 21-day cycles until documented disease progression or unacceptable toxicity
measure: To evaluate the duration of achieved responses
timeFrame: 21-day cycles until documented disease progression or unacceptable toxicity
measure: To evaluate time to progression (TTP)
timeFrame: 21-day cycles until documented disease progression or unacceptable toxicity
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Local Institution
state: Aichi
city: Kashiwa-Shi
country: Japan
facility: Local Institution
state: Chiba
city: Fukuoka-Shi
country: Japan
facility: Local Institution
state: Fukuoka
city: Matabashi-Shi
country: Japan
facility: Local Institution
state: Gunma
city: Kagoshima-Shi
country: Japan
facility: Local Institution
state: Kagoshima
city: Isehara-Shi
country: Japan
facility: Local Institution
state: Kanagawa
city: Niigata-Shi
country: Japan
facility: Local Institution
state: Niigata
city: Iruma-Gun
country: Japan
facility: Local Institution
state: Saitama
city: Utsunomiya
country: Japan
facility: Local Institution
state: Tochigi
city: Bunkyo-Ku
country: Japan
facility: Local Institution
state: Tokyo
city: Chuo-Ku
country: Japan
facility: Local Institution
state: Tokyo
city: Toshima-Ku
country: Japan
facility: Local Institution
state: Tokyo
city: Saitama
country: Japan
facility: Local Institution
city: Tokyo
country: Japan
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: