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Completed

NCT Number: NCT00568022

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

20 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution, Matsuyama, Ehime, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ixabepilone

Drug

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

Other names: IXEMPRA, BMS-247550

Capecitabine

Drug

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: Baseline to Day 42, continuously

    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

  2. Participant Tumor Response at Study Endpoint

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

    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.

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

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

    Cmax = maximum observed plasma concentration of ixabepilone as determined from participant serum samples in one dosing interval.

  4. 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).

    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.

  5. 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).

    T 1/2 = terminal elimination half life as determined from participant serum samples in one dosing interval.

  6. 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).

    Vss = volume of distribution at steady state determined from participant serum samples from one dosing interval.

  7. Mean Ixabepilone Total Body Clearance (CLT) in One Dosing Interval

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

    CLT = total body clearance as determined from participant serum samples in one dosing interval.

Sponsors and collaborators

Lead sponsor

R-Pharm

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Dec 5, 2007
Registry last updated
Mar 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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