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

A Phase 1 study testing Ixabepilone and Capecitabine in people with Breast Cancer, run by R-Pharm at 4 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 20 years and older, women only
Conditions the study is for: Breast Cancer
What is being tested?: Ixabepilone and Capecitabine
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 9 participants
Where: 4 sitesJapan
Study dates: Feb 2008to Jan 2010
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Who cannot join

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

Trial locations and contacts

4 sites in 1 country.

Japan4 sites

Local Institution
Maebashi, Gunma, 371-8511
Local Institution
Matsuyama, Ehime, 7910280
Local Institution
Osaka, Osaka, 540-0006
Local Institution
Sunto-Gun, Shizuoka, 411-8777

Other trials in Japan

About this study

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

Conditions: Breast Cancer
Being tested: Ixabepilone, Capecitabine
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, BMS-247550
Ixabepilone: Intravenous (IV) Solution, IV, 32(40)mg/m^2, once every 3 weeks, up to 6 cycles
CapecitabineDrug
Capecitabine: Tablets, Oral, 1650(2000)mg/m^2, twice daily for 2 weeks, one week off, up to 6 cycles

Study groups in NCT00568022
Study group	Role	What they receive
Ixabepilone + Capecitabine	Experimental	Not described Receives: Drug: Ixabepilone; Drug: Capecitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: From initiation of drug through last day of Cycle 2 (Day 42)
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.
Measured: At the end of Cycle 2 (Day 42)

Secondary outcomes (7)

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
Measured: Baseline to Day 42, continuously
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.
Measured: At baseline and after every 42 days (every 2 21-day cycles) after baseline
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.
Measured: During Cycle 1 at specified timepoints (Day 1 to Day 8).
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.
Measured: During Cycle 1 at specified timepoints (Day 1 to Day 8).
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.
Measured: During Cycle 1 at specified timepoints (Day 1 to Day 8).
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.
Measured: During Cycle 1 at specified timepoints (Day 1 to Day 8).
Mean Ixabepilone Total Body Clearance (CLT) in One Dosing Interval
CLT = total body clearance as determined from participant serum samples in one dosing interval.
Measured: During Cycle 1 at specified timepoints (Day 1 to Day 8).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2008Jan 2010

First posted5 Dec 2007 (estimated)
Study startFeb 2008
Primary completionJan 2010
Study completionJan 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for 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 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 9 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00568022
Sponsor's protocol ID: CA163-117
Status last verified: Feb 2016
First submitted: 3 Dec 2007
Last updated: 10 Mar 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Breast Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00568022
Acronym / sponsor ID: CA163-117
Conditions: Breast Cancer
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 9 participants (actual)
Lead sponsor: R-PharmIndustry (pharma, biotech, devices)
Study start: Feb 2008
Primary completion: Jan 2010 (actual)
Study completion: Jan 2010 (actual)
First posted: 5 Dec 2007 (estimated)
Results: Posted 17 Aug 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Ixabepilone + Capecitabine	Experimental	Drug: Ixabepilone, Drug: Capecitabine

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

Key exclusion criteria (1 listed)

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

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: IXEMPRA, BMS-247550Ixabepilone: Intravenous (IV) Solution, IV, 32(40)mg/m^2, once every 3 weeks, up to 6 cycles	Drug	Ixabepilone + Capecitabine
CapecitabineCapecitabine: Tablets, Oral, 1650(2000)mg/m^2, twice daily for 2 weeks, one week off, up to 6 cycles	Drug	Ixabepilone + Capecitabine

Primary outcome

Participants Experiencing Dose Limiting Toxicity (DLT)
Time frame: 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)
Time frame: 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.

7 secondary outcomes

Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Baseline to Day 42, continuously
Participant Tumor Response at Study Endpoint
Time frame: At baseline and after every 42 days (every 2 21-day cycles) after baseline
Mean Ixabepilone Maximum Plasma Concentration (Cmax) in One Dosing Interval
Time frame: During Cycle 1 at specified timepoints (Day 1 to Day 8).
Mean Ixabepilone Area Under the Concentration Curve (AUC INF) in One Dosing Interval
Time frame: During Cycle 1 at specified timepoints (Day 1 to Day 8).
Mean Ixabepilone Terminal Elimination Half Life (T 1/2) in One Dosing Interval
Time frame: During Cycle 1 at specified timepoints (Day 1 to Day 8).
Mean Ixabepilone Volume of Distribution at Steady State (Vss) in One Dosing Interval
Time frame: During Cycle 1 at specified timepoints (Day 1 to Day 8).
Mean Ixabepilone Total Body Clearance (CLT) in One Dosing Interval
Time frame: During Cycle 1 at specified timepoints (Day 1 to Day 8).

Results and safety

Results posted to the registry on 17 Aug 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day	3	3
Ixabepilone 40 mg/m^2 + Capecitabine 1650 mg/m^2/Day	3	3
Ixabepilone 40 mg/m^2 + Capecitabine 2000 mg/m^2/Day	3	3

Primary outcome: Participants Experiencing Dose Limiting Toxicity (DLT)

Time frame: From initiation of drug through last day of Cycle 2 (Day 42). Number. Unit: Participants

Measure	Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day n = 3	Ixabepilone 40 mg/m^2 + Capecitabine 1650 mg/m^2/Day n = 3	Ixabepilone 40 mg/m^2 + Capecitabine 2000 mg/m^2/Day n = 3
Value	0	0	0

Population analysed: All participants who received at least 1 dose of either ixabepilone or capecitabine.

Primary outcome: Participants Achieving the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D)

Time frame: At the end of Cycle 2 (Day 42). Number. Unit: Participants

Measure	All Participants With Measurable Disease and Tumor Response n = 3
Ixa 40 mg/m^2 + Cap 2000 mg/m^2 MTD	3
Ixa 40 mg/m^2 + Cap 2000 ng/m^2 RP2D	3

Population analysed: All participants treated at the highest dose level.

7 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day	0 of 3 (0%)	3 of 3 (100%)	Not reported
Ixabepilone 40 mg/m^2 + Capecitabine 1650 mg/m^2/Day	1 of 3 (33.3%)	3 of 3 (100%)	Not reported
Ixabepilone 40 mg/m^2 + Capecitabine 2000 mg/m^2/Day	1 of 3 (33.3%)	3 of 3 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Breast Cancer

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Not yet recruitingObservational study
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RecruitingPhase 3
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TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8

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

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Ixabepilone and Capecitabine in people with Breast Cancer, run by R-Pharm at 4 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 10 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Aug 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Participants Experiencing Dose Limiting Toxicity (DLT) (time frame: From initiation of drug through last day of Cycle 2 (Day 42)). 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?

On the ClinicalTrials.gov record for NCT00568022.

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 10 Mar 2016.