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

NCT00780000 | Terminated Phase 2

• 3 other identifiers: CA201-0022007-003121-25KDG-201
• Study Type: interventional
• Target: 4
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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

  (all patients were off study by June 2008)

  Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days)

Secondary Outcomes (14)

• 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

• 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)

• 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

• 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

• 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

Study Arms (1)

A1

EXPERIMENTAL

Drug: Alvespimycin

Interventions

Alvespimycin 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

A1

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

MeSH Terms

Conditions

Breast Neoplasms

Interventions

17-(dimethylaminoethylamino)-17-demethoxygeldanamycin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2008
• First Posted: October 24, 2008
• Study Start: April 1, 2008
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: November 4, 2015

Record last verified: 2015-10