Open-label Study of STA-9090 for Patients With Metastatic Breast Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01273896|
Recruitment Status : Completed
First Posted : January 11, 2011
Results First Posted : November 20, 2015
Last Update Posted : November 20, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: STA-9090||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Open-label Study of STA-9090 for Patients With Metastatic Breast Cancer|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||September 2013|
|Actual Study Completion Date :||September 2013|
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.
- Overall Response Rate [ Time Frame: Radiological imaging studies to evaluate tumor status will be repeated during the rest week (Days 22 to 28) of every third cycle ]To determine the overall response rate using RECIST v 1.1 criteria, defined as PR +CR.using RECIST v 1.1 criteria, defined as Partial response + complete response
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01273896
|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|