STA-9090 in Patients With Advanced Hepatocellular Cancer

Mass General Brigham

Status and phase

Completed

Phase 1

Conditions

Hepatocellular Carcinoma

Treatments

Drug: STA-9090

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01665937

10-072

Details and patient eligibility

About

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.

Full 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.

Enrollment

16 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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