STA-9090 in Patients With Advanced Hepatocellular Cancer

A Phase I Study of STA-9090 in Patients With Advanced Hepatocellular Carcinoma

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.

Study Overview

• Status: Completed
• Conditions: Hepatocellular Carcinoma
• Intervention / Treatment: Drug: STA-9090

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.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Dana-Farber Cancer Institute
    • Boston, Massachusetts, United States, 02115
      • Beth Israel Deaconess Medical Center
    • Boston, Massachusetts, United States, 02115
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: STA-9090; Patients receiving STA-9090

Drug: STA-9090; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 years
Median time to progression (TTP)	To determine median time to progression (TTP) for patients treated at recommended Phase 2 dose.	3 years
Median progression-free survival (PFS)	To determine median progression-free survival (PFS) for patients treated at recommended Phase 2 dose.	3 years
Response Rate	To determine objective tumor response rate using RECIST criteria	3 years
Overall Survival	To determine overall survival	3 years

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Dana-Farber Cancer Institute; Beth Israel Deaconess Medical Center; Synta Pharmaceuticals Corp.
• Investigators: Principal Investigator: Andrew Zhu, MD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: April 27, 2010
• First Submitted That Met QC Criteria: August 15, 2012
• First Posted (Estimate): August 16, 2012

Study Record Updates

• Last Update Posted (Actual): April 25, 2018
• Last Update Submitted That Met QC Criteria: April 23, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: liver cancer; advanced liver cancer; advanced hepatocellular cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular
• Other Study ID Numbers: 10-072

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO