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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00568022
First received: December 3, 2007
Last updated: February 23, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: Ixabepilone
Drug: Capecitabine
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Participants Experiencing Dose Limiting Toxicity (DLT) [ Time Frame: From initiation of drug through last day of Cycle 2 (Day 42) ] [ Designated as safety issue: Yes ]
    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) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline to Day 42, continuously ] [ Designated as safety issue: Yes ]
    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

  • Participant Tumor Response at Study Endpoint [ Time Frame: At baseline and after every 42 days (every 2 21-day cycles) after baseline ] [ Designated as safety issue: No ]
    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.

  • Mean Ixabepilone Maximum Plasma Concentration (Cmax) in One Dosing Interval [ Time Frame: During Cycle 1 at specified timepoints (Day 1 to Day 8). ] [ Designated as safety issue: No ]
    Cmax = maximum observed plasma concentration of ixabepilone as determined from participant serum samples in one dosing interval.

  • 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). ] [ Designated as safety issue: No ]
    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.

  • 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). ] [ Designated as safety issue: No ]
    T 1/2 = terminal elimination half life as determined from participant serum samples in one dosing interval.

  • 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). ] [ Designated as safety issue: No ]
    Vss = volume of distribution at steady state determined from participant serum samples from one dosing interval.

  • Mean Ixabepilone Total Body Clearance (CLT) in One Dosing Interval [ Time Frame: During Cycle 1 at specified timepoints (Day 1 to Day 8). ] [ Designated as safety issue: No ]
    CLT = total body clearance as determined from participant serum samples in one dosing interval.


Enrollment: 9
Study Start Date: February 2008
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ixabepilone + Capecitabine Drug: Ixabepilone
Ixabepilone: Intravenous (IV) Solution, IV, 32(40)mg/m^2, once every 3 weeks, up to 6 cycles
Other Names:
  • IXEMPRA
  • BMS-247550
Drug: Capecitabine
Capecitabine: Tablets, Oral, 1650(2000)mg/m^2, twice daily for 2 weeks, one week off, up to 6 cycles

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00568022

Locations
Japan
Local Institution
Matsuyama-Shi, Ehime, Japan, 7910280
Local Institution
Maebashi-Shi, Gunma, Japan, 371-8511
Local Institution
Sunto-Gun, Shizuoka, Japan, 411-8777
Local Institution
Osaka, Japan, 540-0006
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00568022     History of Changes
Other Study ID Numbers: CA163-117
Study First Received: December 3, 2007
Results First Received: June 3, 2011
Last Updated: February 23, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Capecitabine
Fluorouracil
Epothilones
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on September 16, 2014