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

Phase 1
18 Years
Open (Enrolling)
Hepatocellular Carcinoma

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Trial Information

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

Study treatment is given in 4-week time periods called cycles. Patients will receive
ST-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.

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
- 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

- 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

- Ventricular ejection fraction
- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the Phase 2 dose of STA 9090 given once weekly in patients with advanced hepatocellular carcinoma

Outcome 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.

Outcome Time Frame:

2-3 years

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

August 2010

Completion Date:

August 2012

Related Keywords:

  • Hepatocellular Carcinoma
  • liver cancer
  • advanced liver cancer
  • advanced hepatocellular cancer
  • Carcinoma
  • Liver Neoplasms
  • Carcinoma, Hepatocellular



Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Massachusetts General HospitalBoston, Massachusetts  02114-2617