Clinical and Translational Study of STA-9090
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.
|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 II Clinical and Translational Study of STA-9090 in Patients With Refractory Metastatic Colorectal Cancer|
- To assess the objective response rate. (ORR) [ Time Frame: every 8 weeks ] [ Designated as safety issue: No ]
- To determine the progression-free survival (PFS) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- To determine overall survival (OS) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- To determine the durations of stable disease. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- To determine overall response. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- To evaluate the safety. [ Time Frame: every cycle ] [ Designated as safety issue: Yes ]
- To evaluate tumor tissue samples for molecular markers correlative with response or resistance to STA-9090 therapy [ Time Frame: 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||April 2010|
|Study Completion Date:||July 2012|
|Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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.|