Open-label Study of STA-9090 for Patients With Metastatic Breast Cancer
The purpose of this study is to find out what effects, good and/or bad, STA-9090 has on the patient and their breast cancer.
STA-9090 is an experimental drug that works by breaking down cancer proteins. When the cancer proteins are destroyed, the cancer cells die. STA-9090 is an experimental drug that is not yet approved for the treatment of cancer by the United States (FDA) Food and Drug Administration . STA-9090 has been tested in cancer patients in other trials and a safe dose for this drug has been found. We are now interested to see how active this drug is against breast cancer.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 2 Open-label Study of STA-9090 for Patients With Metastatic Breast Cancer|
- To determine the overall response rate using RECIST v 1.1 criteria, defined as Partial response + complete response [ Time Frame: Radiological imaging studies to evaluate tumor status will be repeated during the rest week (Days 22 to 28) of every third cycle ] [ Designated as safety issue: No ]using RECIST v 1.1 criteria, defined as Partial response + complete response
- To determine the duration of response [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- To further characterize the safety profile of STA-9090 [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]AEs will be defined based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.
- To determine the clinical benefit rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]defined as CR+PR+ SD ≥6 months
- To determine progression free survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]Median PFS and overall survival will be estimated by the Kaplan-Meier method.
- To determine time to response [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- To determine overall survival. [ Time Frame: 1 year ] [ Designated as safety issue: No ]Median PFS and overall survival will be estimated by the Kaplan-Meier method. Subject survival information will be collected every 12 weeks (± 1 week) from the date of last dose of study drug until the subject's death or until the subject is lost to follow-up, or until study closure.
|Study Start Date:||January 2011|
|Study Completion Date:||September 2013|
|Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
This will be a monotherapy, open-label phase 2 study of STA-9090 in patients who have metastatic breast cancer.
All patients will receive 200 mg/m2 of STA-9090 once weekly by a 1-hour IV infusion for three consecutive weeks followed by a 1 week dose-free interval. Subjects tolerating therapy may continue on study until disease progression.
|United States, New Jersey|
|Memorial Sloan-Kettering at Basking Ridge|
|Basking Ridge, New Jersey, United States, 07920|
|United States, New York|
|Memorial Sloan-Kettering Cancer Center at Commack|
|Commack, New York, United States, 11725|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Memorial Sloan-Kettering Cancer Center at Mercy Medical Center|
|Rockville Centre, New York, United States, 11570|
|Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center|
|Sleepy Hollow, New York, United States, 10591|
|Principal Investigator:||Shanu Modi, MD||Memorial Sloan-Kettering Cancer Center|