Clinical trial NCT00780000: Clinical Trial of Intravenous Alvespimycin in Patients With Her2 Positive Breast Cancer
Official title: Phase 2 Clinical Trial of Intravenous Alvespimycin [KOS-1022] in Patients With Her2 Positive Breast Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2008-10-24
Enrollment: 4
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: 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
timeFrame: Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days)
Secondary outcomes:
measure: Adverse Events assessed according to the NCI CTCAE (v 3.0) grading system
timeFrame: Within 28 days prior to the start of treatment, and for 167 days
measure: Laboratory tests assessed according to the NCI CTCAE (v 3.0) grading system
timeFrame: 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)
measure: Vital signs
timeFrame: 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
measure: Karnofsky Performance Status
timeFrame: Within 28 days prior to the start of treatment, prior to each 4-week cycle starting with Cycle 2, for 167 days
measure: Ocular testing
timeFrame: 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
measure: Kaplan-Meier estimate of time to progression
timeFrame: Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days)
measure: Time to progression on the patient's prior cytotoxic chemotherapy compared to the patient's time to progression on alvespimycin
timeFrame: Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days)
measure: Kaplan-Meier estimate of progression-free survival
timeFrame: Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days)
measure: Kaplan-Meier estimate of time to response
timeFrame: Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days)
measure: Kaplan-Meier estimate of duration of response
timeFrame: Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days)
measure: Kaplan-Meier estimate of time to treatment failure
timeFrame: Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days)
measure: Kaplan-Meier estimate of overall survival
timeFrame: Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days)
measure: Changes in tumor markers
timeFrame: Within 28 days prior to the start of treatment, Prior to each 4-week cycle starting with Cycle 2, for 167 days
measure: Histopathological and molecular profile of responding and non-responding patients using paraffin-embedded surgical specimens
timeFrame: Specimens were obtained within 28 days prior to the start of treatment
Other outcomes:
Locations:
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: