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.
NCCN-sponsored studies funded through the grant mechanism are highlighted below.
A Phase I Trial of GSK2118436 (BRAFi) and Pazopanib in Patients With BRAF-Mutated Advanced Malignant Tumors
Protocol Chair: Manisha Shah, MD
Institutional Principal Investigators: Manisha Shah, MD, and Filip Janku, MD, PhD
Condition: Adult malignant tumors with BRAF mutation
Institutions: The Ohio State University Comprehensive Cancer Center - James Cancer Hospital and Solove Research Institute, and The University of Texas MD Anderson Cancer Center
This is a bi-institutional, dose-escalation phase I trial that studies the side effects and maximum tolerated dose of dabrafenib (GSK2118436) and pazopanib when given together in treating patients with advanced malignant tumors whose tumors harbor BRAF mutation. Dabrafenib and pazopanib may stop the growth of tumor cells by blocking angiogenesis and some of the enzymes needed for cell growth.
Patients receive dabrafenib orally (PO) twice daily and pazopanib hydrochloride PO once daily on days 1 through 28 (one course is 28 days). Treatment is continued in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 4 weeks.
Primary Objective:
To assess the safety and tolerability of dabrafenib given with pazopanib and determine the maximum tolerated dosing regimen in patients with BRAF-mutated advanced malignant tumors.
Secondary Objectives:
Evaluate pharmacokinetics of the 2 study drugs and identify potential drug–drug interactions.
Determine pharmacogenomics with microarray testing.
Perform genotyping of tumors and if objective tumor response rates are correlated.
Assess objective tumor response rates.
Contacts: Ohio State University Medical Center • 1-800-293-5066 • Jamesline@osumc.edu
Manisha Shah, MD • 614-293-8629 • manisha.shah@osumc.edu The University of Texas MD Anderson Cancer Center:
Filip Janku, MD, PhD • 713-563-2632 • fjanku@mdanderson.org ClinicalTrials.gov Identifier: NCT01713972
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.
