STA-9090(Ganetespib) in Metastatic Ocular Melanoma

This study is currently recruiting participants.
Verified February 2014 by Dana-Farber Cancer Institute
Sponsor:
Collaborators:
Beth Israel Deaconess Medical Center
Massachusetts General Hospital
Brigham and Women's Hospital
Synta Pharmaceuticals Corp.
Information provided by (Responsible Party):
F. Stephen Hodi, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT01200238
First received: September 10, 2010
Last updated: February 26, 2014
Last verified: February 2014

September 10, 2010
February 26, 2014
June 2010
November 2014   (final data collection date for primary outcome measure)
  • Progression Free Survival Rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To determine the proportion of patients alive, free of disease progression, and still taking STA-9090 at 4 months.
  • Expression of cMET [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To estimate the proportion of patients with greater than 50% decrease in expression of HSP90 client protein c-MET 18-24 hours after administration of STA-9090
Same as current
Complete list of historical versions of study NCT01200238 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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STA-9090(Ganetespib) in Metastatic Ocular Melanoma
A Phase II Study of the HSP Inhibitor STA-9090 in Metastatic Ocular Melanoma

STA-9090 is 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 the cells have the right shape. By stopping it's activity, these molecules never get to have the right structure to be functional and they are destroyed. We believe that if we stop the activity of HSP90, the rapidly dividing cells in the tumor(s) will slow down since their proteins will not be functional without the help of HSP90.

  • Participants will receive STA-9090 intravenously over 1 hour once a week for the first three weeks of a 4 week cycle (days 1, 8 and 15).
  • During the first cycle (Cycle 1) participants will have the following tests and procedures performed at the time point indicated: Day 1 and Day 15: clinical exam, vital signs, ECG and blood tests. Day 2: Biopsy of tumor and blood tests. Day 8: clinical exam, vital signs and blood tests. Days 16-18: PET scan.
  • On Day 1 of all subsequent even cycles (4, 6, 8, etc.) the following tests and procedures will be performed: clinical exam, vital signs, ECG, blood tests and urine sample. On days 8 and 15 of all subsequent even cycles the following tests and procedures will be performed: clinical exam, vital signs and blood tests. On days 22-28 of all even cycles and assessment of the tumor will also be performed.
  • On Day 1 of all subsequent odd cycles (3, 5, 7, etc.) the following tests and procedures will be performed: clinical exam, vital signs and blood tests.
Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Ocular Melanoma
Drug: STA-9090
Given intravenously once week for three weeks of a four week cycle
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
February 2015
November 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically confirmed stage IV ocular melanoma
  • ECOG Performance status 0, 1, or 2
  • 18 years of age or older
  • Laboratory values as indicated in the protocol
  • Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation
  • Presence of metastatic disease that would be amenable to the required biopsies
  • At least one site of measurable disease as defined by at least 1cm in greatest dimension. This site must be different from the sites to be used for biopsy. No prior radiation therapy or directed ablation to the site of measurable disease

Exclusion Criteria:

  • Chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
  • Major surgery within 4 weeks prior to first dose of STA-9090
  • Minor surgery within 7 days of first dose of STA-9090
  • Embolization procedure or ablation procedure to treat tumor within 4 weeks of first dose
  • Participants may not be receiving any other investigational agents
  • Poor venous access for study drug administration unless patient can use silicone based catheters
  • History of brain metastases or of leptomeningeal involvement
  • History of allergic reactions or hypersensitivity reactions attributed to compounds of similar chemical or biologic composition to STA-9090
  • Baseline QTc > 450 msec or previous history of QT prolongation while taking other medications
  • Ventricular ejection fraction (EF) of 55% or less at baseline
  • Treatment with chronic immunosuppressants
  • Melanoma of cutaneous, mucosal or acral-lentiginous origin or of unknown primary
  • Prior treatment with HSP90 inhibitor
  • Not willing to undergo biopsy before and after treatment
  • Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Other medications, or severe acute/chronic medical or psychiatric conditions or laboratory abnormality that may increase the risk associated with the study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the participant inappropriate for entry into the study
  • Pregnant or breastfeeding women
  • Individual with a history of a different malignancy are ineligible except for circumstances outlined in the protocol
  • HIV-positive individuals on combination antiretroviral therapy
  • History of or current coronary artery disease, myocardial infarction, angina pectoris, angioplasty or coronary bypass surgery
  • History of or current uncontrolled dysrhythmias, or requirement for antiarrhythmic medication, or Grade 2 or greater left bundle branch block
  • NYHA class II/III/IV congestive heart failure with a history of dyspnea, orthopnea or edema that requires current treatment with angiotensin converting enzyme inhibitors, angiotensin II receptor blockers, beta-blockers or diuretics
  • Current or prior radiation therapy to the left hemithorax
Both
18 Years and older
No
Contact: F. Stephen Hodi, MD 617-632-5053 stephen_hodi@dfci.harvard.edu
United States
 
NCT01200238
10-137
Yes
F. Stephen Hodi, MD, Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
  • Beth Israel Deaconess Medical Center
  • Massachusetts General Hospital
  • Brigham and Women's Hospital
  • Synta Pharmaceuticals Corp.
Principal Investigator: F. Stephen Hodi, MD Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP