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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00780000
• Other study ID #: CA201-002
• Secondary ID: 2007-003121-25KD
• Status: Terminated
• Phase: Phase 2
• First received: October 23, 2008
• Last updated: October 12, 2015
• Start date: April 2008
• Est. completion date: June 2008

Study information

• Verified date: October 2015
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ministry of Health of the Russian FederationRomania: National Medicines AgencyUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Adverse Events assessed according to the NCI CTCAE (v 3.0) grading system	(all patients were off study by June 2008)	Within 28 days prior to the start of treatment, and for 167 days	Yes
Secondary	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)	Yes
Secondary	Vital signs	(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	Yes
Secondary	Karnofsky Performance Status	(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	Yes
Secondary	Ocular testing	(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	Yes
Secondary	Kaplan-Meier estimate of time to progression	(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)	No
Secondary	Time to progression on the patient's prior cytotoxic chemotherapy compared to the patient's time to progression on alvespimycin	(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)	No
Secondary	Kaplan-Meier estimate of progression-free survival	(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)	No
Secondary	Kaplan-Meier estimate of time to response	(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)	No
Secondary	Kaplan-Meier estimate of duration of response	(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)	No
Secondary	Kaplan-Meier estimate of time to treatment failure	(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)	No
Secondary	Kaplan-Meier estimate of overall survival	(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)	No
Secondary	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	No
Secondary	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	No

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm