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Xylometazoline

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.

STA-9090

Andrew Zhu, MD

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 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.

STA-9090 in Patients With Advanced Hepatocellular Cancer

A Phase I Study of STA-9090 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.

To assess the safety and tolerability of STA9090 in patients with advanced hepatocellular carcinoma.

To determine median time to progression (TTP) for patients treated at recommended Phase 2 dose.

To determine median progression-free survival (PFS) for patients treated at recommended Phase 2 dose.

To determine objective tumor response rate using RECIST criteria

Dana-Farber Cancer Institute

Beth Israel Deaconess Medical Center

Synta Pharmaceuticals Corp.

Massachusetts General Hospital

MD, PhD

Tivozanib

Protein Kinase Inhibitors

Enzyme Inhibitors

Patients would receive Tivozanib 1.0 mg/day orally, 3 weeks on, one week off, for one cycle starting day 1. If no adverse event is encountered, patients will continue subsequent cycles of Tivozanib 1.5 mg/day orally; 3 weeks on/1 week off, dosing schedule. Patients will continue on treatment until disease progression, unacceptable toxicity, or patient withdrawal from the study.

Bassel El-Rayes, MD

The purpose of this study is to learn about the effect of the investigational agent tivozanib on the control of the tumor growth in hepatocellular (liver) cancer. The investigators also plan to collect information on the likelihood to develop side effects while on this treatment. Tivozanib is an oral medication (pill) taken once a day. This medication is designed to stop the tumor from developing new blood vessels.

Angiogenesis is the formation of new blood vessels. Angiogenesis is driven by cytokines including vascular endothelial growth factor. Tivozanib is an oral medication that inhibits vascular endothelial growth factor preventing tumor from developing new blood vessels.

The purpose of this study is to evaluate the effects of tivozanib on hepatocellular (liver) cancer. Participants in the study take tivozanib daily at a dose of 1 mg for 1month. if doing well the dose would be increased to 1.5 mg per day. Patients are monitored for response using CT or MRI scans every 2months. In addition, patients will have blood draws to evaluate the effects of tivozanib on blood vessels.

Phase II Trial of Tivozanib in Advanced Hepatocellular Cancer

Evaluation of disease progression in the patients with advanced hepatocellular cancer (HCC) receiving tivozanib will be made using CT or MRI scan of the organ(s) with the target lesion(s). Response Evaluation Criteria In Solid Tumors (RECIST) criteria 1.1 will be used for objective tumor response assessment. Measurable lesions can be measured in at least one dimension as ≥ 20 mm with conventional CT scan techniques or as ≥ 10 mm with spiral CT scan. Target lesions are all measurable lesions up to a maximum of 5 lesions. Target lesions are selected for their size and suitability for accurate repetitive measurements. The sum of the longest diameter of all target lesions will be calculated and reported as the baseline sum longest diameter (LD). This will be used as a reference to further quantify objective response.

Measurable lesions: Lesions that can be measured in at least one dimension as ≥ 20 mm with conventional CT scan techniques or as ≥ 10 mm with spiral CT scan.

Non-measurable lesions: All other lesions including small lesions (longest diameter \< 20 mm with conventional techniques) and other non-measurable lesions including: pleural effusions, ascites, and disease documented by indirect evidence (e.g. biochemical abnormalities).

Target lesions: All measurable lesions up to a maximum of 5 lesions. Target lesions are selected for their size and suitability for accurate repetitive measurements. The sum of the longest diameter of all target lesions will be calculated and reported as the baseline sum longest diameter (LD). This will be used as a reference to further quantify objective response.

Non-target lesions: All other lesions are identified as non-target lesions and should be followed as present or absent.

AVEO Pharmaceuticals, Inc.

Emory University

Study Principal Investigator

Patients would receive Tivozanib 1.0 mg/day orally, 3 weeks on, one week off, for one cycle starting day 1. If no adverse event is encountered, patients will continue subsequent cycles of Tivozanib 1.5 mg/day orally; 3 weeks on/1 week off, dosing schedule. Patients will continue on treatment until disease progression, unacceptable toxicity, or patient withdrawal from the study.

Tivozanib: Oral medication given daily. No placebo.

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Number of Patients With Advanced Hepatocellular Cancer (HCC) Receiving Tivozanib Who Are Free From Progression

No response was observed in any of the patients.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
STA-9090 in Patients With Advanced Hepatocellular Cancer	NCT01665937	Hepatocellular ...	STA-9090	18 Years -	Massachusetts General Hospital
Phase II Trial of Tivozanib in Advanced Hepatocellular Cancer	NCT01807156	Hepatocellular ...	Tivozanib	18 Years -	Emory University

Spots Global Cancer Trial Database for advanced hepatocellular cancer