Back to resultsSTA-9090 in Patients With Advanced Hepatocellular Cancer
Primary Purpose
Hepatocellular Carcinoma
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
STA-9090
Sponsored by
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring liver cancer, advanced liver cancer, advanced hepatocellular cancer
Eligibility Criteria
Inclusion Criteria:
- Histologically or cytologically confirmed hepatocellular carcinoma
- Measurable disease
- Life expectancy greater than 3 months
- ECOG performance status 0 or 1
- BCLC Stage C disease
- Lab values must be within limits outlined in protocol
- Child-Pugh score </= 6
- CLIP score 0-3
- Must agree to use adequate contraception
Exclusion Criteria:
- Chemotherapy or radiotherapy within 4 weeks prior to entering study or not recovered from adverse events due to agents administered more than 4 weeks earlier
- Receiving any other investigational agent
- Known brain metastases unless treated and radiographically and clinically stable without steroid or anticonvulsant medications for at least 4 weeks prior to first dose of STA-9090
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to STA-9090
- Surgery, radiotherapy, or lesion ablative procedure to the only area of measurable disease
- Major surgery within 4 weeks prior to first dose of STA-9090
- Poor venous access for study drug administration or would require a peripheral or central indwelling catheter for study drug administration
- History of severe allergic or hypersensitivity reactions to excipients (e.g., Polyethylene glycol [PE] 300 and Polysorbate 80)
- Baseline QTc > 450 msec or previous history of QT prolongation while taking other medications
- Ventricular ejection fraction </= 55% at baseline
- Treatment with chronic immunosuppressants
- 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
- Pregnant or breast-feeding
- History of a different malignancy unless disease-free for at least 5 years and deemed by the investigator to be at low risk for recurrence.
- HIV-positive individuals on combination antiretroviral therapy
Sites / Locations
- Beth Israel Deaconess Medical Center
- Dana-Farber Cancer Institute
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
STA-9090
Arm Description
Patients receiving STA-9090
Outcomes
Primary Outcome Measures
Phase 2 dose of STA 9090 given once weekly in patients with advanced hepatocellular carcinoma
Dose escalation/de-escalation study will be performed in order to determine the Phase 2 dose of STA-9090 given once weekly in patients with advanced hepatocellular carcinoma. The dose limiting toxicities will be determined at each dose level.
Secondary Outcome Measures
Number of patients with adverse events when treated with STA 9090 for advanced hepatocellular carcinoma
To assess the safety and tolerability of STA9090 in patients with advanced hepatocellular carcinoma.
Median time to progression (TTP)
To determine median time to progression (TTP) for patients treated at recommended Phase 2 dose.
Median progression-free survival (PFS)
To determine median progression-free survival (PFS) for patients treated at recommended Phase 2 dose.
Response Rate
To determine objective tumor response rate using RECIST criteria
Overall Survival
To determine overall survival
Full Information
NCT ID
NCT01665937
First Posted
April 27, 2010
Last Updated
April 23, 2018
Sponsor
Massachusetts General Hospital
Collaborators
Dana-Farber Cancer Institute, Beth Israel Deaconess Medical Center, Synta Pharmaceuticals Corp.
1. Study Identification
Unique Protocol Identification Number
NCT01665937
Brief Title
STA-9090 in Patients With Advanced Hepatocellular Cancer
Official Title
A Phase I Study of STA-9090 in Patients With Advanced Hepatocellular Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Dana-Farber Cancer Institute, Beth Israel Deaconess Medical Center, Synta Pharmaceuticals Corp.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
STA-9090 works by inhibiting the function of a protein in tumor cells called Hsp90. Hsp90 is thought to play a role in tumor growth. By interfering with this protein's function, STA-9090 may help kill tumor cells. This drug has been used in other research studies and information from those studies suggests that this agent may help to slow tumor growth in HCC.
The purpose of this research study is to find the highest dose of STA-9090 that can safely be given to participants with advanced HCC. The investigators will also get more information about the safety of STA-9090 and perform tests to learn more about how STA-9090 affects the body.
Detailed Description
Study treatment is given in 4-week time periods called cycles. Patients will receive ST-9090 once weekly for the first 3 weeks of each cycle and no treatment on the fourth week. STA-9090 will be given by intravenous (IV) infusion. IV infusions occur through an IV catheter (or tube) placed in the vein. Each infusion will last about 60 minutes.
During each cycles patients will have blood tests, pregnancy test, and EKG. Twenty to thirty days after the last dose, patients will return for a physical exam, blood tests, urine test, EKG, and CT or MRI of chest and abdomen.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
liver cancer, advanced liver cancer, advanced hepatocellular cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
STA-9090
Arm Type
Experimental
Arm Description
Patients receiving STA-9090
Intervention Type
Drug
Intervention Name(s)
STA-9090
Intervention Description
IV one time weekly for 3 weeks in 4 week cycles. Study treatment is given in 4-week time periods called cycles. Patients will receive STA-9090 for the first 3 weeks of each cycle and no treatment on the fourth week. STA-9090 will be given by intravenous (IV) infusion. IV infusions occur through an IV catheter (or tube) placed in the vein. Each infusion will last about 60 minutes.
During each cycles patients will have blood tests, pregnancy test, and EKG. Twenty to thirty days after the last dose, patients will return for a physical exam, blood tests, urine test, EKG, and CT or MRI of chest and abdomen.
Primary Outcome Measure Information:
Title
Phase 2 dose of STA 9090 given once weekly in patients with advanced hepatocellular carcinoma
Description
Dose escalation/de-escalation study will be performed in order to determine the Phase 2 dose of STA-9090 given once weekly in patients with advanced hepatocellular carcinoma. The dose limiting toxicities will be determined at each dose level.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Number of patients with adverse events when treated with STA 9090 for advanced hepatocellular carcinoma
Description
To assess the safety and tolerability of STA9090 in patients with advanced hepatocellular carcinoma.
Time Frame
3 years
Title
Median time to progression (TTP)
Description
To determine median time to progression (TTP) for patients treated at recommended Phase 2 dose.
Time Frame
3 years
Title
Median progression-free survival (PFS)
Description
To determine median progression-free survival (PFS) for patients treated at recommended Phase 2 dose.
Time Frame
3 years
Title
Response Rate
Description
To determine objective tumor response rate using RECIST criteria
Time Frame
3 years
Title
Overall Survival
Description
To determine overall survival
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically or cytologically confirmed hepatocellular carcinoma
Measurable disease
Life expectancy greater than 3 months
ECOG performance status 0 or 1
BCLC Stage C disease
Lab values must be within limits outlined in protocol
Child-Pugh score </= 6
CLIP score 0-3
Must agree to use adequate contraception
Exclusion Criteria:
Chemotherapy or radiotherapy within 4 weeks prior to entering study or not recovered from adverse events due to agents administered more than 4 weeks earlier
Receiving any other investigational agent
Known brain metastases unless treated and radiographically and clinically stable without steroid or anticonvulsant medications for at least 4 weeks prior to first dose of STA-9090
History of allergic reactions attributed to compounds of similar chemical or biologic composition to STA-9090
Surgery, radiotherapy, or lesion ablative procedure to the only area of measurable disease
Major surgery within 4 weeks prior to first dose of STA-9090
Poor venous access for study drug administration or would require a peripheral or central indwelling catheter for study drug administration
History of severe allergic or hypersensitivity reactions to excipients (e.g., Polyethylene glycol [PE] 300 and Polysorbate 80)
Baseline QTc > 450 msec or previous history of QT prolongation while taking other medications
Ventricular ejection fraction </= 55% at baseline
Treatment with chronic immunosuppressants
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
Pregnant or breast-feeding
History of a different malignancy unless disease-free for at least 5 years and deemed by the investigator to be at low risk for recurrence.
HIV-positive individuals on combination antiretroviral therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Zhu, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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STA-9090 in Patients With Advanced Hepatocellular Cancer
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