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.

NCCN-sponsored studies funded through the grant mechanism are highlighted below.

A Phase II Study of Axitinib (AG-013736) in Patients With Progressive, Recurrent/Metastatic Adenoid Cystic Carcinoma

Principal Investigator: Alan L. Ho, MD, PhD

Condition: Adenoid cystic carcinoma

Institution: Memorial Sloan-Kettering Cancer Center

This single-arm phase II study is evaluating the clinical efficacy of axitinib in the treatment of patients with progressive, recurrent/metastatic adenoid cystic carcinoma (ACC). A 2-stage design will be used. All eligible patients will receive a starting axitinib dose of 5 mg, twice daily (BID), taken orally in 4-week (28-day) cycles. Patients who tolerate axitinib with no adverse events related to study drug above Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v 4.0) grade 2 for a consecutive 2-week period may have their dose increased by one dose level to a maximum of 10 mg BID according to the discretion of the treating physician (unless the patient’s blood pressure is > 150/90 mm Hg or the patient is receiving antihypertensive medication). This dose escalation is not mandatory.

RECIST v1.1 tumor assessments will be made at baseline (CT or MRI) and then approximately every 2 cycles (or every 8 weeks [± 1 week]). After 10 months, imaging will be performed approximately every 3 cycles (or every 12 weeks [± 1 week]). Patients may remain in the study until disease progression or unacceptable toxicity. Other reasons patients could potentially come off study include patient noncompliance, patient withdrawal of consent, or physician’s clinical judgment that removal from the study is in the patient’s best interest.

Primary Objective:

  • Determine the best overall response rate documented by RECIST v1.1 criteria of patients with progressive, recurrent/metastatic ACC treated with axitinib.

Secondary Objective:

  • Determine the median progression-free survival.

Exploratory Objective:

  • Evaluate the hypothesis that ACC tumor responses to axitinib are correlated to baseline expression of PDGFR and/or c-myb–driven expression of c-kit and VEGFR.

Contact: Alan L. Ho, MD, PhD • 646-888-4235

ClinicalTrials.gov Identifier: NCT01558661

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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