Metastatic Breast CancerPhase 2NCT01027208
A Rollover Study of Ixabepilone (BMS-247550) In Patients With Metastatic Breast Cancer Previously Treated With An Anthracycline
A Phase 2 study testing Ixabepilone in people with Metastatic Breast Cancer, run by R-Pharm at 14 sites in Japan.
Trial summary
To provide extended access to Ixabepilone therapy to subjects with metastatic breast cancer who have completed the previous Phase II study (CA163-107) Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Ixabepilone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 14 sitesJapan
- Study dates
- Dec 2006to Jan 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≥2
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Japan14 sites
Local Institution
Bunkyo-Ku, Tokyo, 113-8677
Local Institution
Chuo-Ku, Tokyo, 104-0045
Local Institution
Fukuoka, Fukuoka
Local Institution
Iruma-Gun, Saitama, 350-0495
Local Institution
Isehara-Shi, Kanagawa, 259-1193
Local Institution
Kagoshima, Kagoshima-ken, 892-0833
Local Institution
Kashiwa-Shi, Chiba, 277-0882
Local Institution
Matabashi-Shi, Gunma, 371-8511
Local Institution
Nagoya, Aichi-ken, 464-8681
Local Institution
Niigata, Niigata, 951-8566
Local Institution
Saitama, Saitama
Local Institution
Tokyo, Tokyo
Local Institution
Toshima-Ku, Tokyo, 170-8455
Local Institution
Utsunomiya, Tochigi, 320-0834
About this study
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
To provide extended access to Ixabepilone therapy to subjects with metastatic breast cancer who have completed the previous Phase II study (CA163-107)
- Conditions
- Metastatic Breast Cancer
- Being tested
- Ixabepilone
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IxabepiloneDrug
Also called Ixempra
Lyophilized and solvent, IV, 10-50 mg/m²
| Study group | Role | What they receive |
|---|---|---|
| Ixabepilone | Experimental | Not described Receives: Drug: Ixabepilone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 21-day cycles until documented disease progression or unacceptable toxicity
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
Measured: 21-day cycles until documented disease progression or unacceptable toxicity
Secondary outcomes (4)
Secondary objectives will be assessed by combining data with the previous Phase II study CA163107
Measured: 21-day cycles until documented disease progression or unacceptable toxicity
To evaluate the antitumor response according to the RECIST criteria
Measured: 21-day cycles until documented disease progression or unacceptable toxicity
To evaluate the duration of achieved responses
Measured: 21-day cycles until documented disease progression or unacceptable toxicity
To evaluate time to progression (TTP)
Measured: 21-day cycles until documented disease progression or unacceptable toxicity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2009 (estimated)
- Study startDec 2006
- Primary completionJan 2007
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- R-Pharm
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01027208
- Sponsor's protocol ID
- CA163-130
- Status last verified
- Jan 2017
- First submitted
- 4 Dec 2009
- Last updated
- 30 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01027208
- Acronym / sponsor ID
- CA163-130
- Conditions
- Metastatic Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- R-PharmIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 7 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To provide extended access to Ixabepilone therapy to subjects with metastatic breast cancer who have completed the previous Phase II study (CA163-107)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ixabepilone | Experimental | Drug: Ixabepilone |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≥2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IxabepiloneAlso: IxempraLyophilized and solvent, IV, 10-50 mg/m² | Drug | Ixabepilone |
Primary outcome
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
Time frame: 21-day cycles until documented disease progression or unacceptable toxicity
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
Time frame: 21-day cycles until documented disease progression or unacceptable toxicity
4 secondary outcomes
Secondary objectives will be assessed by combining data with the previous Phase II study CA163107
Time frame: 21-day cycles until documented disease progression or unacceptable toxicity
To evaluate the antitumor response according to the RECIST criteria
Time frame: 21-day cycles until documented disease progression or unacceptable toxicity
To evaluate the duration of achieved responses
Time frame: 21-day cycles until documented disease progression or unacceptable toxicity
To evaluate time to progression (TTP)
Time frame: 21-day cycles until documented disease progression or unacceptable toxicity
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ixabepilone in people with Metastatic Breast Cancer, run by R-Pharm at 14 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 21-day cycles until documented disease progression or unacceptable toxicity). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2017.