STA-9090(Ganetespib) in Patients With Unresectable Stage III or Stage IV Melanoma

Melanoma Clinical Trial

Official title: A Phase II Study of the HSP90 Inhibitor STA-9090 in Patients With Unresectable Stage III or Stage IV Melanoma Who Received Prior Tyrosine Kinase Inhibitor Treatment

Status Active, not recruiting

Clinical Trial Summary

STA9090 is a drug which inactivates or blocks the work of a protein called Heat Shock Protein 90 or HSP90. HSP90 is a protein that helps some molecules inside your cells to have the right shape. By stopping HSP90's activity, those molecules never get to have the right structure of be functional and they are destroyed. The investigators believe that if they stop the activity of HSP90, the rapidly dividing cells that are in your tumor(s) may slow down. In this research study the investigators are looking to see how well STA9090 works in stopping the spread of your melanoma.

Clinical Trial Description

STA-9090 will be given intravenously over 1 hour. Treatment will be given in cycles which last 28 days (4 weeks). Study drug will be given once a week for the first 3 weeks (days 1, 8 and 15) and not during the last week.

Subjects will receive a clinical exam, ECG (before and after study drug) and blood tests on days when they receive the study drug. In Cycle 1, subjects will have a biopsy and blood samples taken on Day 2.

20 to 30 days after the last study treatment, subjects will have a clinical exam, ECG, blood tests, pregnancy test (if applicable), tumor assessment by CT, urine sample and possible biopsy. ;

Study Design

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

Related Conditions & MeSH terms

• Melanoma

• NCT number: NCT01551693
• Study type: Interventional
• Source: Dana-Farber Cancer Institute
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: September 2011
• Completion date: January 2017