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
  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:


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
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: NCT00780000

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

Additional Information:
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 September 22, 2014