Clinical trial NCT01807156: Phase II Trial of Tivozanib in Advanced Hepatocellular Cancer
Official title: Phase II Trial of Tivozanib in Advanced Hepatocellular Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Hepatocellular Cancer
Keywords: Tivozanib
Advanced hepatocellular cancer
Angiogenesis
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: AVEO Pharmaceuticals, Inc.
First posted: 2013-03-08
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Patients with measurable, histological diagnosis of hepatocellular carcinoma (HCC) and whose disease is not amenable to surgical or regional therapy.
2. Prior allowed therapy:

   * Surgery including hepatic resection

     1. Minimum of 4 weeks since any surgical procedure.
     2. Patients must have adequately recovered from surgery.
   * Regional therapy

     1. Includes transarterial chemoembolization (TACE), drug-eluting bead \[DEB\]-TACE, percutaneous ethanol injection, radiofrequency/cryo ablation, Yttrium-90 radioembolization.
     2. More than 2 weeks must have lapsed from therapy.
     3. There must be an indicator lesion outside the treated area or clear evidence of progression in the treated lesion, not amenable for further local therapies.
     4. Concomitant sorafenib with regional therapy is allowed as long as no evidence of progression on sorafenib.
   * Prior adjuvant sorafenib is allowed, if completed more than 6 months prior to disease recurrence.
3. Adequate hematological, liver and metabolic organ function.
4. Signed informed consent.

Exclusion Criteria:

1. Patients with mixed histology or fibrolamellar variant.
2. Prior systemic therapy for metastatic disease.
3. Uncontrolled hypertension (HTN).
4. Symptomatic heart failure.

Primary outcomes:
measure: Number of Patients With Advanced Hepatocellular Cancer (HCC) Receiving Tivozanib Who Are Free From Progression
timeFrame: 6 Months
Secondary outcomes:
measure: Response Rate Based on Response Evaluation Criteria in Solid Tumors (RECIST) Criteria
timeFrame: 6 months
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University, Winship Cancer Institute
state: Georgia
Study officials:
affiliation: Emory University Winship Cancer Institute
name: Bassel El-Rayes, MD
role: PRINCIPAL_INVESTIGATOR
References: