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Clinical Trial of Intravenous Alvespimycin in Patients With Her2 Positive Breast Cancer

Primary Purpose

Breast Cancer

Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Alvespimycin
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • KPS performance status of >= 80% ("normal activity with effort")
  • Metastatic breast cancer with Her2 amplification by FISH or 3+ Her2 overexpression by immunohistochemistry ("IHC")
  • Must have received no more than one prior cytotoxic chemotherapy regimen in the metastatic setting
  • Measurable disease by RECIST Criteria

Exclusion Criteria:

  • Received prior lapatinib, an investigational ErbB-2 and/or an investigational EGFR dual tyrosine kinase inhibitors
  • Administration of any other chemotherapy, biological, immunotherapy or investigational agent within 14 days prior to receipt of study medication
  • Pregnant or breast-feeding women. Known CNS metastases, unless treated and without clinically significant neurological deficits
  • Moderately severe dry eye
  • Congestive heart failure, or a left ventricular ejection fraction
  • Myocardial infarction or active ischemic heart disease within 12 months prior to study drug administration
  • Previous malignancies unless free of recurrence for at least 5 years

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    A1

    Arm Description

    Outcomes

    Primary Outcome Measures

    Objective tumor response rate (either RECIST or WHO complete response, partial response or minor response) confirmed by CT and MRI as the preferred methods for tumor assessments and Chest x-ray is acceptable for pulmonary lesions
    (all patients were off study by June 2008)

    Secondary Outcome Measures

    Adverse Events assessed according to the NCI CTCAE (v 3.0) grading system
    (all patients were off study by June 2008)
    Laboratory tests assessed according to the NCI CTCAE (v 3.0) grading system
    Vital signs
    (all patients were off study by June 2008)
    Karnofsky Performance Status
    (all patients were off study by June 2008)
    Ocular testing
    (all patients were off study by June 2008)
    Kaplan-Meier estimate of time to progression
    (all patients were off study by June 2008)
    Time to progression on the patient's prior cytotoxic chemotherapy compared to the patient's time to progression on alvespimycin
    (all patients were off study by June 2008)
    Kaplan-Meier estimate of progression-free survival
    (all patients were off study by June 2008)
    Kaplan-Meier estimate of time to response
    (all patients were off study by June 2008)
    Kaplan-Meier estimate of duration of response
    (all patients were off study by June 2008)
    Kaplan-Meier estimate of time to treatment failure
    (all patients were off study by June 2008)
    Kaplan-Meier estimate of overall survival
    (all patients were off study by June 2008)
    Changes in tumor markers
    Histopathological and molecular profile of responding and non-responding patients using paraffin-embedded surgical specimens

    Full Information

    First Posted
    October 23, 2008
    Last Updated
    October 12, 2015
    Sponsor
    Bristol-Myers Squibb
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00780000
    Brief Title
    Clinical Trial of Intravenous Alvespimycin in Patients With Her2 Positive Breast Cancer
    Official Title
    Phase 2 Clinical Trial of Intravenous Alvespimycin [KOS-1022] in Patients With Her2 Positive Breast Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2015
    Overall Recruitment Status
    Terminated
    Study Start Date
    April 2008 (undefined)
    Primary Completion Date
    June 2008 (Actual)
    Study Completion Date
    June 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Bristol-Myers Squibb

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to determine the anti-tumor activity (via objective response rate) of alvespimycin in patients with breast cancer who have not previously received trastuzumab (except as adjuvant therapy).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    4 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    A1
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Alvespimycin
    Intervention Description
    Solution, IV, Alvespimycin 80 mg/m2, Weekly one hour infusion Days 1, 8, and 15, every 4 weeks thereafter until disease progression or DLT
    Primary Outcome Measure Information:
    Title
    Objective tumor response rate (either RECIST or WHO complete response, partial response or minor response) confirmed by CT and MRI as the preferred methods for tumor assessments and Chest x-ray is acceptable for pulmonary lesions
    Description
    (all patients were off study by June 2008)
    Time Frame
    Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days)
    Secondary Outcome Measure Information:
    Title
    Adverse Events assessed according to the NCI CTCAE (v 3.0) grading system
    Description
    (all patients were off study by June 2008)
    Time Frame
    Within 28 days prior to the start of treatment, and for 167 days
    Title
    Laboratory tests assessed according to the NCI CTCAE (v 3.0) grading system
    Time Frame
    Within 10 days prior to Cycle 1/1st infusion; within 48 hours of infusion (Cycle 1/Weeks 2/3/4 and Cycle 2+/Week3), or within 72 hours prior to infusion (Cycle 2+/Week 1)
    Title
    Vital signs
    Description
    (all patients were off study by June 2008)
    Time Frame
    Within 28 days prior to the start of treatment, Day1 of Weeks 1, 2, and 3 of Cycle 1 (4 weeks long), and prior to each 4-week cycle starting with Cycle 2, for 167 days
    Title
    Karnofsky Performance Status
    Description
    (all patients were off study by June 2008)
    Time Frame
    Within 28 days prior to the start of treatment, prior to each 4-week cycle starting with Cycle 2, for 167 days
    Title
    Ocular testing
    Description
    (all patients were off study by June 2008)
    Time Frame
    Within 28 days prior to the start of treatment, Cycle 1/Day 10 (3 days +/- 1 day following the 2nd infusion in the first cycle of therapy), prior to Cycle 2, if clinically indicated thereafter, for 167 days
    Title
    Kaplan-Meier estimate of time to progression
    Description
    (all patients were off study by June 2008)
    Time Frame
    Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days)
    Title
    Time to progression on the patient's prior cytotoxic chemotherapy compared to the patient's time to progression on alvespimycin
    Description
    (all patients were off study by June 2008)
    Time Frame
    Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days)
    Title
    Kaplan-Meier estimate of progression-free survival
    Description
    (all patients were off study by June 2008)
    Time Frame
    Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days)
    Title
    Kaplan-Meier estimate of time to response
    Description
    (all patients were off study by June 2008)
    Time Frame
    Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days)
    Title
    Kaplan-Meier estimate of duration of response
    Description
    (all patients were off study by June 2008)
    Time Frame
    Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days)
    Title
    Kaplan-Meier estimate of time to treatment failure
    Description
    (all patients were off study by June 2008)
    Time Frame
    Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days)
    Title
    Kaplan-Meier estimate of overall survival
    Description
    (all patients were off study by June 2008)
    Time Frame
    Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days)
    Title
    Changes in tumor markers
    Time Frame
    Within 28 days prior to the start of treatment, Prior to each 4-week cycle starting with Cycle 2, for 167 days
    Title
    Histopathological and molecular profile of responding and non-responding patients using paraffin-embedded surgical specimens
    Time Frame
    Specimens were obtained within 28 days prior to the start of treatment

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: KPS performance status of >= 80% ("normal activity with effort") Metastatic breast cancer with Her2 amplification by FISH or 3+ Her2 overexpression by immunohistochemistry ("IHC") Must have received no more than one prior cytotoxic chemotherapy regimen in the metastatic setting Measurable disease by RECIST Criteria Exclusion Criteria: Received prior lapatinib, an investigational ErbB-2 and/or an investigational EGFR dual tyrosine kinase inhibitors Administration of any other chemotherapy, biological, immunotherapy or investigational agent within 14 days prior to receipt of study medication Pregnant or breast-feeding women. Known CNS metastases, unless treated and without clinically significant neurological deficits Moderately severe dry eye Congestive heart failure, or a left ventricular ejection fraction Myocardial infarction or active ischemic heart disease within 12 months prior to study drug administration Previous malignancies unless free of recurrence for at least 5 years
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Bristol-Myers Squibb
    Organizational Affiliation
    Bristol-Myers Squibb
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Clinical Trial of Intravenous Alvespimycin in Patients With Her2 Positive Breast Cancer

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