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

NCT ID: NCT01551693

Last Updated: 2017-04-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2012-09-30

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

Conditions

Melanoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

STA-9090 Cohort A

Patients enrolled into two possible cohorts based on tumor expression of BRAF: Cohort A - BRAF mutant disease or Cohort B - BRAF wild type. Cohort A patients received STA-9090 200 mg/m2 once weekly (d1, 8, 15 of 28 day cycle). Patients were treated until evidence of disease progression, unacceptable toxicity, intercurrent illness or withdrawal.

Group Type: EXPERIMENTAL

STA-9090

Intervention Type: DRUG

STA-9090 Cohort B

Patients enrolled into two possible cohorts based on tumor expression of BRAF: Cohort A - BRAF mutant disease or Cohort B - BRAF wild type. Cohort B patients received STA-9090 150 mg/m2 twice weekly (d1, 4, 8, 11, 15, 18 of 28 day cycle). Patients were treated until evidence of disease progression, unacceptable toxicity, intercurrent illness or withdrawal.

Group Type: EXPERIMENTAL

STA-9090

Intervention Type: DRUG

Interventions

STA-9090

Intervention Type: DRUG

Other Intervention Names

Ganetespib

Eligibility Criteria

Inclusion Criteria

• No HIV-positive subject on combination antiretroviral therapy
• No more than 3 prior systemic therapies for unresectable stage III or stage IV melanoma
• No concomitant use of medications associated with a high incidence of QT prolongation as outlined

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Synta Pharmaceuticals Corp.

INDUSTRY

Sponsor Role: collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

F. Stephen Hodi, MD

Melanoma Disease Center Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

F. Stephen Hodi, M.D.

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

11-039

Identifier Type: -

Identifier Source: org_study_id