Clinical Trial of Intravenous Alvespimycin in Patients With Her2 Positive Breast Cancer - Full Text View

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00780000

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 II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

U.S. FDA Resources

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

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 ]

Secondary Outcome Measures:

Kaplan-Meier estimates of time-to-event variables will be used (time to progression, progression-free survival, time to response, duration of response, time to treatment failure and overall survival). [ Time Frame: Time to event analyses ] [ Designated as safety issue: No ]
Time to progression on the patient's prior cytotoxic chemotherapy to the patient's time to progression on alvespimycin will be compared [ Time Frame: Time to event analyses ] [ Designated as safety issue: No ]

Estimated Enrollment:	25
Study Start Date:	April 2008
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A1: Experimental	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

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:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	CA201-002, EUDRACT #: 2007-003121-25, KDG-201
Study First Received:	October 23, 2008
Last Updated:	November 4, 2008
ClinicalTrials.gov Identifier:	NCT00780000 History of Changes
Health Authority:	Russia: Ministry of Health and Social Development of the Russian Federation; Romania: National Medicines Agency; United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study placed in the following topic categories:

Skin Diseases
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Skin Diseases
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on May 07, 2009