Oncology Research Program

Highlights of the NCCN Oncology Research Program

The NCCN Oncology Research Program (ORP) strives to improve the quality of life for patients and reduce cancer-related deaths by advancing cancer therapies through research. Since the program's establishment in 1999, the NCCN ORP has brought millions of dollars in research grants to investigators at NCCN Member Institutions. Research grants are provided to NCCN through collaborations with pharmaceutical and biotechnology companies; these grants are in turn used to support scientifically meritorious cancer research efforts.

NCCN ORP studies typically explore new avenues of clinical investigation and seek answers to important cancer-related questions. All studies are approved and funded through a scientific peer-review process and are overseen by the ORP.

An NCCN study funded through the grant mechanism is highlighted below.

Multicenter Phase Ib/II Study of Tivozanib in Patients With Advanced Inoperable Hepatocellular Carcinoma

Principal Investigator: Renuka Iyer, MD

Conditions: Adult primary hepatocellular carcinoma, advanced adult primary liver cancer, localized unresectable adult primary liver cancer, and recurrent adult primary liver cancer

Institutions: Roswell Park Cancer Institute, Case Western Reserve University, and Cleveland Clinic

This is a phase Ib/II study of tivozanib in patients with advanced inoperable hepatocellular carcinoma (HCC). Based on monotherapy tolerability data of tivozanib from 14 studies, an oral dose of 1.5 mg daily has been recommended for phase II testing. Because tivozanib has not been tested in patients with HCC, and patients with HCC who are candidates for systemic therapies tend to have Child-Pugh class A or early B cirrhosis, this study will start with a phase I dose-escalation study. The phase Ib portion of the study follows a modified 3 + 3 design. Typical 3 + 3 studies start at the lowest dose. This modified design starts patients at the middle dose. The first 3 patients will be treated with a 1 mg oral once-daily dose. Depending on observed toxicity rates, the dose may be deescalated to 0.5 mg or escalated to 1.5 mg. The dose of 1.5 mg daily is expected to be the recommended phase II dose. The standard 3 + 3 dose (de)escalation rules will be followed. Dose level will be considered tolerable following completion of first cycle of treatment.

Primary Objective:

  • Progression-free survival (PFS) at 24 weeks in patients with advanced HCC

Secondary Objectives:

  • Determine the safety of tivozanib in HCC

  • Determine the overall survival and clinical benefit rate (complete response, partial response, and stable disease) by RECIST

  • Determine the steady-state pharmacokinetics and soluble vascular endothelial growth factor receptor 2 baseline/change with tivozanib and use modeling to correlate exposure with biomarker change and the primary outcome measure of PFS

  • Determine the change in viral load (hepatitis B virus [HBV] and hepatitis C virus [HCV]) during therapy in patients with HBV- or HCV-associated HCC.

  • Determine the change in tumor marker (alpha-fetoprotein) with tivozanib therapy and the effect of tivozanib on several tumor-associated immune response markers

Contact: Roswell Park • 877-275-7724 • ASKRPCI@roswellpark.org

ClinicalTrials.gov Identifier: NCT01835223

The goal of the Highlights of the NCCN Oncology Research Program (ORP) is to provide readers with more information on the ORP, including studies currently accruing patients.

For more information on specific trials, including patient selection criteria, please use the contact information listed with each study.

For more information on the NCCN ORP, including a complete detailing of the clinical studies currently underway at NCCN Member Institutions, please access the NCCN ORP pages at NCCN.org/clinical_trials/clinicians.asp.

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