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

This study has been terminated.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00780000
First received: October 23, 2008
Last updated: June 6, 2011
Last verified: June 2011
History of Changes
  Purpose

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).


Condition Intervention Phase
Breast Cancer
 Drug: Alvespimycin
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 2 Clinical Trial of Intravenous Alvespimycin [KOS-1022] in Patients With Her2 Positive Breast Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

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 [ Time Frame: Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days) ] [ Designated as safety issue: No ]
    (all patients were off study by June 2008)


Secondary Outcome Measures:
  • Adverse Events assessed according to the NCI CTCAE (v 3.0) grading system [ Time Frame: Within 28 days prior to the start of treatment, and for 167 days ] [ Designated as safety issue: Yes ]
    (all patients were off study by June 2008)

  • 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) ] [ Designated as safety issue: Yes ]
  • Vital signs [ 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 ] [ Designated as safety issue: Yes ]
    (all patients were off study by June 2008)

  • Karnofsky Performance Status [ Time Frame: Within 28 days prior to the start of treatment, prior to each 4-week cycle starting with Cycle 2, for 167 days ] [ Designated as safety issue: Yes ]
    (all patients were off study by June 2008)

  • Ocular testing [ 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 ] [ Designated as safety issue: Yes ]
    (all patients were off study by June 2008)

  • Kaplan-Meier estimate of time to progression [ Time Frame: Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days) ] [ Designated as safety issue: No ]
    (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 [ Time Frame: Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days) ] [ Designated as safety issue: No ]
    (all patients were off study by June 2008)

  • Kaplan-Meier estimate of progression-free survival [ Time Frame: Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days) ] [ Designated as safety issue: No ]
    (all patients were off study by June 2008)

  • Kaplan-Meier estimate of time to response [ Time Frame: Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days) ] [ Designated as safety issue: No ]
    (all patients were off study by June 2008)

  • Kaplan-Meier estimate of duration of response [ Time Frame: Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days) ] [ Designated as safety issue: No ]
    (all patients were off study by June 2008)

  • Kaplan-Meier estimate of time to treatment failure [ Time Frame: Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days) ] [ Designated as safety issue: No ]
    (all patients were off study by June 2008)

  • Kaplan-Meier estimate of overall survival [ Time Frame: Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days) ] [ Designated as safety issue: No ]
    (all patients were off study by June 2008)

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

Enrollment: 4
Study Start Date: April 2008
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A1 Drug: Alvespimycin
Solution, IV, Alvespimycin 80 mg/m2, Weekly one hour infusion Days 1, 8, and 15, every 4 weeks thereafter until disease progression or DLT

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00780000

Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00780000     History of Changes
Other Study ID Numbers: CA201-002, 2007-003121-25, KDG-201
Study First Received: October 23, 2008
Last Updated: June 6, 2011
Health Authority: Russia: Ministry of Health of the Russian Federation
Romania: National Medicines Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 21, 2013