Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2026-02-28 @ 10:38 PM
Study NCT ID:
NCT01551693
Status:
TERMINATED
Last Update Posted:
2017-04-12
First Post:
2011-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
STA-9090(Ganetespib) in Patients With Unresectable Stage III or Stage IV Melanoma
Sponsor:
Dana-Farber Cancer Institute
Organization:
Study Overview
Official Title:
This Trial is an Open Label, Parallel Cohort, Phase II Study Evaluating the Efficacy of the Heat Shock Protein 90 (Hsp90) Inhibitor STA-9090 in Patients With Unresectable Stage III or Stage IV Melanoma Who Were Intolerant of, or Progressed on, Prior Tyrosine Kinase Inhibitor Treatment. Two Cohorts Will Enroll Concurrently. One Cohort Will be Composed of Patients With Melanoma Expressing a Mutation in the Protein BRAF and the Other Cohort Will be Composed of Patients With Melanoma Expressing Wild-type BRAF.
Status:
TERMINATED
Status Verified Date:
2017-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
due to weak accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
OBJECTIVES:
Primary
* To determine the proportion of patients alive, free of disease progression, and still taking STA-9090 at 6 months by BRAF mutant or wild type (WT) status.
Secondary
* To assess best overall response rate and six month response rate by BRAF status
* To evaluate the rates of one-year overall survival and progression-free survival by BRAF status
* To determine safety and tolerability of STA-9090 by BRAF status
Exploratory
* To compare the rates of response and of six-month PFS between BRAF status cohorts
* To explore, using peripheral blood mononuclear cells, the relationship between change in expression of hsp90 client proteins (e.g., BRAF, CRAF, AKT, CDK4, KIT) with response to therapy and progression free survival by BRAF status
* To explore the relationship in biopsied melanoma metastases between changes in expression of hsp90 client proteins (e.g., BRAF, CRAF, AKT, CDK4, KIT) with response to therapy and progression-free survival
* To explore response rate and 6 month progression free survival, in subset of patients with melanoma expressing a mutation in KIT
Primary
* To determine the proportion of patients alive, free of disease progression, and still taking STA-9090 at 6 months by BRAF mutant or wild type (WT) status.
Secondary
* To assess best overall response rate and six month response rate by BRAF status
* To evaluate the rates of one-year overall survival and progression-free survival by BRAF status
* To determine safety and tolerability of STA-9090 by BRAF status
Exploratory
* To compare the rates of response and of six-month PFS between BRAF status cohorts
* To explore, using peripheral blood mononuclear cells, the relationship between change in expression of hsp90 client proteins (e.g., BRAF, CRAF, AKT, CDK4, KIT) with response to therapy and progression free survival by BRAF status
* To explore the relationship in biopsied melanoma metastases between changes in expression of hsp90 client proteins (e.g., BRAF, CRAF, AKT, CDK4, KIT) with response to therapy and progression-free survival
* To explore response rate and 6 month progression free survival, in subset of patients with melanoma expressing a mutation in KIT
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: