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

NCT ID: NCT00780000

Last Updated: 2015-11-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2008-06-30

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).

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A1

Group Type: EXPERIMENTAL

Alvespimycin

Intervention Type: DRUG

Solution, IV, Alvespimycin 80 mg/m2, Weekly one hour infusion Days 1, 8, and 15, every 4 weeks thereafter until disease progression or DLT

Interventions

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Other Identifiers

2007-003121-25

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

KDG-201

Identifier Type: OTHER

Identifier Source: secondary_id

CA201-002

Identifier Type: -

Identifier Source: org_study_id