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

Phase 2

Terminated

• Conditions: Breast Cancer
• Interventions: Drug: Alvespimycin

• Registration Number: NCT00780000
• Lead Sponsor: Bristol-Myers Squibb

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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2008-04
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Study First Submitted: 2008-10-23
• Study First Submitted QC: 2008-10-23
• Study First Posted: 2008-10-24
• Disposition First Submitted: 2010-09-10
• Disposition First Submitted QC: 2010-09-10
• Disposition First Posted: 2010-09-14
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-12
• Last Update Posted: 2015-11-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 4

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A1	Alvespimycin	-

Primary Outcome Measures

Name	Time	Method
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	Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days)	(all patients were off study by June 2008)

Secondary Outcome Measures

Name	Time	Method
Adverse Events assessed according to the NCI CTCAE (v 3.0) grading system	Within 28 days prior to the start of treatment, and for 167 days	(all patients were off study by June 2008)
Kaplan-Meier estimate of time to response	Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days)	(all patients were off study by June 2008)
Kaplan-Meier estimate of time to treatment failure	Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days)	(all patients were off study by June 2008)
Laboratory tests assessed according to the NCI CTCAE (v 3.0) grading system	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)
Kaplan-Meier estimate of duration of response	Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days)	(all patients were off study by June 2008)
Histopathological and molecular profile of responding and non-responding patients using paraffin-embedded surgical specimens	Specimens were obtained within 28 days prior to the start of treatment
Karnofsky Performance Status	Within 28 days prior to the start of treatment, prior to each 4-week cycle starting with Cycle 2, for 167 days	(all patients were off study by June 2008)
Kaplan-Meier estimate of time to progression	Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days)	(all patients were off study by June 2008)
Vital signs	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	(all patients were off study by June 2008)
Ocular testing	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	(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	Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days)	(all patients were off study by June 2008)
Kaplan-Meier estimate of progression-free survival	Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days)	(all patients were off study by June 2008)
Kaplan-Meier estimate of overall survival	Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days)	(all patients were off study by June 2008)
Changes in tumor markers	Within 28 days prior to the start of treatment, Prior to each 4-week cycle starting with Cycle 2, for 167 days