STA-9090 in Patients With Advanced Hepatocellular Cancer

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01665937
• Other study ID #: 10-072
• Status: Completed
• Phase: Phase 1
• First received: April 27, 2010
• Last updated: April 23, 2018
• Start date: August 2010
• Est. completion date: March 2014

Study information

• Verified date: April 2018
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: March 2014
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Liver Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (4)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Beth Israel Deaconess Medical Center, Dana-Farber Cancer Institute, Synta Pharmaceuticals Corp.

Country where clinical trial is conducted

United States, 

Outcome

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