Clinical and Translational Study of STA-9090
|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: NCT01111838|
Recruitment Status : Completed
First Posted : April 28, 2010
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 colorectal cancer. This is a phase II trial which tests both how well the drug works in fighting your cancer as well as any possible side effects it will have on the patient.
Cancer is a disease of uncontrolled growth. This growth is controlled in part by a series of proteins that are part of a growth pathway. Some of these proteins are destroyed by a protein called HSP90 and STA-9090 is a test drug which blocks one of the proteins that helps cancer grow. This study will also look at molecular markers that may affect how the cancer grows, and how it responds to treatment.
|Condition or disease||Intervention/treatment||Phase|
|Colon Cancer Rectal Cancer||Drug: STA-9090||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Clinical and Translational Study of STA-9090 in Patients With Refractory Metastatic Colorectal Cancer|
|Study Start Date :||April 2010|
|Actual Primary Completion Date :||July 2012|
|Actual Study Completion Date :||July 2012|
This is an open-label Phase 2 clinical study in patients with advanced colorectal cancer (CRC). Patients will be treated with 200mg/m2 of STA-9090 during a 1-hour intravenous infusion 1 time per week for three consecutive weeks followed by a 1 week dose-free interval. Patients tolerating STA-9090 will be permitted to continue treatment until disease progression.
Patients will be enrolled and receive 200mg/m2 of STA-9090. Patients will receive single agent STA-9090 intravenous (I.V.) infusion (an indwelling catheter may not be used) over 60 minutes weekly (three weeks on and one week off). Follow-up imaging will be performed every 8 weeks to evaluate response.
- To Determine Overall Objective Response. [ Time Frame: every 8 weeks ]Patients with measurable disease will be evaluated using RECIST criteria for determination of 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): NCT01111838
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Andrea Cercek, MD||Memorial Sloan Kettering Cancer Center|