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

October 12, 2015 updated by: Bristol-Myers Squibb

Phase 2 Clinical Trial of Intravenous Alvespimycin [KOS-1022] in Patients With Her2 Positive Breast Cancer

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
(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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
(all patients were off study by June 2008)
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
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)
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
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
(all patients were off study by June 2008)
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
Time Frame: 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)
Within 28 days prior to the start of treatment, prior to each 4-week cycle starting with Cycle 2, for 167 days
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
(all patients were off study by June 2008)
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
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)
(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)
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)
(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)
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)
(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)
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)
(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)
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)
(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)
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)
(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)
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)
(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)
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
Within 28 days prior to the start of treatment, Prior to each 4-week cycle starting with Cycle 2, for 167 days
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
Specimens were obtained within 28 days prior to the start of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (ACTUAL)

June 1, 2008

Study Completion (ACTUAL)

June 1, 2008

Study Registration Dates

First Submitted

October 23, 2008

First Submitted That Met QC Criteria

October 23, 2008

First Posted (ESTIMATE)

October 24, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

November 4, 2015

Last Update Submitted That Met QC Criteria

October 12, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA201-002
  • 2007-003121-25 (EUDRACT_NUMBER)
  • KDG-201 (OTHER: Kosan)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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