NCT00568022

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for phase_1 breast-cancer

Timeline
Completed

Started Feb 2008

Shorter than P25 for phase_1 breast-cancer

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 3, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 5, 2007

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2008

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

August 17, 2011

Completed
Last Updated

March 10, 2016

Status Verified

February 1, 2016

Enrollment Period

1.9 years

First QC Date

December 3, 2007

Results QC Date

June 3, 2011

Last Update Submit

February 9, 2016

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

  • 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)

  • 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)

Secondary Outcomes (7)

  • Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Baseline to Day 42, continuously

  • Participant Tumor Response at Study Endpoint

    At baseline and after every 42 days (every 2 21-day cycles) after baseline

  • Mean Ixabepilone Maximum Plasma Concentration (Cmax) in One Dosing Interval

    During Cycle 1 at specified timepoints (Day 1 to Day 8).

  • Mean Ixabepilone Area Under the Concentration Curve (AUC INF) in One Dosing Interval

    During Cycle 1 at specified timepoints (Day 1 to Day 8).

  • Mean Ixabepilone Terminal Elimination Half Life (T 1/2) in One Dosing Interval

    During Cycle 1 at specified timepoints (Day 1 to Day 8).

  • +2 more secondary outcomes

Study Arms (1)

Ixabepilone + Capecitabine

EXPERIMENTAL
Drug: IxabepiloneDrug: Capecitabine

Interventions

IxabepiloneDRUG

Ixabepilone: Intravenous (IV) Solution, IV, 32(40)mg/m\^2, once every 3 weeks, up to 6 cycles

Also known as: IXEMPRA, BMS-247550
Ixabepilone + Capecitabine
CapecitabineDRUG

Capecitabine: Tablets, Oral, 1650(2000)mg/m\^2, twice daily for 2 weeks, one week off, up to 6 cycles

Ixabepilone + Capecitabine

Eligibility Criteria

Age20 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Local Institution

Matsuyama, Ehime, 7910280, Japan

Location

Local Institution

Maebashi, Gunma, 371-8511, Japan

Location

Local Institution

Osaka, Osaka, 540-0006, Japan

Location

Local Institution

Sunto-Gun, Shizuoka, 411-8777, Japan

Location

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Interventions

ixabepiloneCapecitabine

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

DeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

Title
BMS Study Director
Organization
Bristol-Myers Squibb
Clinical.Trials@bms.com

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2007

First Posted

December 5, 2007

Study Start

February 1, 2008

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

March 10, 2016

Results First Posted

August 17, 2011

Record last verified: 2016-02

Locations

JP(4)