ACCRF has compiled a list of clinical trials for ACC patients with progressive disease to consider. This website is updated periodically, but may not list all the pertinent and available trials. Patients may search on their own for recruiting ACC clinical trials on the ClinicalTrials.gov website.
The clinical trials are broken down into four categories. The first table lists studies that are recruiting only ACC or salivary gland cancer patients (usually phase II clinical trials). The second table lists phase I studies of drugs that target molecules suspected of driving the progression of most cases of ACC (such as FGFR and CDK9). The drugs included in the first two tables are presumed to have similar activity across all ACC patients. However, every ACC tumor has its own molecular profile and may be driven by additional molecular alterations. For patients whose tumors have been profiled and found to harbor an alteration in the NOTCH pathway, the third table lists phase I studies to consider. The fourth and final table includes clinical trials that incorporate tumor profiling prior to selecting a drug (“basket studies”). In all cases, patients should consult with their physicians to discuss the appropriate course of action.
Not all clinical trials have similarly strong scientific rationales for why the drugs should be effective in ACC. The most promising studies will involve drugs that (1) target the known mechanisms of action that drive ACC progression, (2) demonstrate activity in preclinical models of ACC, and (3) have reports of clinical benefit in an ACC patient from a case study or Phase I clinical trial. To assist patients in appraising each clinical trial, we indicate whether the evidence supporting the scientific rationale is strong, solid or fair. This assessment is based on the underlying scientific rationale, and does not mean that a particular trial is better or worse for any given patient, and should be considered along with his or her physician.
The table below lists clinical trials that currently are recruiting ACC patients in particular or salivary gland cancer patients. Links are provided to descriptions of the drugs as well as the www.ClinicalTrials.gov summary of each study.
Clinical Trials Recruiting ACC Patients (Updated September 2016)
Compound Targets Sponsor Locations Scientific Rationale Info Link Contact Lenvatinib FGFR, VEGFR, PDGFR Istituto Nazionale dei Tumori Milan, Italy Solid View Roberta Granata
0223902765 ext +39
Lenvatinib FGFR, VEGFR, PDGFR Memorial Sloan Kettering New York, NY Solid View Alan L. Ho, MD. PhD
Axitinib VEGFR, PDGFR, KIT Seoul National University Seoul, Korea Solid View Bhumsuk Kim
Apatinib VEGFR Shanghai Jiao Tong University Shanghai, China Solid View Guopei Zhu, M.D
Pembrolizumab with Vorinostat
(for salivary gland cancer patients, including ACC)
PD-1 and HDAC University of Washington Seattle, WA Solid View Cristina P. Rodriguez
(for salivary gland cancer patients, including ACC)
PD-1 Merck USA (CA, FL, IL, IN, MD, MN, NJ, TX),
Australia, Canada, Denmark, France, Germany, Israel, Japan, Korea, Netherlands, Norway, Russia, Spain, Taiwan, UK
Solid View 888-577-8839 Proton vs. Intensity-Modulated Radiation Therapy
(for locally advanced ACC in the head and neck, not for metastases)
NA Massachusetts General Hospital Boston, MA Strong View Annie W Chan, MD 617-726-7559 firstname.lastname@example.org
Barbara Winrich, MS 617-724-2334 email@example.com
Generally, patients prefer Phase II clinical trials to Phase I clinical trials because the toxicity of drugs in Phase II studies is well understood, the dosages are at levels known to be effective, and the drugs are hypothesized to be particularly effective in the specific tumor type. In addition, Phase II studies may have less stringent eligibility criteria, more plentiful slots and a higher likelihood of insurance coverage. However, if a patient is unable or unwilling to travel to a Phase II study, there are Phase I studies that offer ACC patients access to promising drugs closer to home. In addition, the scientific rationale for the drug’s effectiveness in ACC may be greater in some Phase I studies than in some Phase II studies.
The table below provides a list of selected Phase I clinical trials of drugs that inhibit molecular targets suspected of contributing to tumor growth in most ACC patients (CDK9 and MDM2).
Selected Phase I Clinical Trials (Updated September 2016)
Compound Targets Sponsor Location Scientific Rationale Info Link Contact CYC065 CDK9 Cyclacel Boston, MA Solid View Andrew Wolanski, NP
HDM201 MDM2 Novartis USA (MA, NY), France, Germany, Japan, Netherlands, Singapore, Spain, Taiwan Solid View Novartis Pharmaceuticals
DS-3032b MDM2 Daiichi Sankyo Detroit, MI
New York, NY
Solid View Andrew Ruwe, PhD
513-579-9911 ext 2353
A significant subset of ACC tumors, perhaps 15-20%, have alterations in the NOTCH pathway (primarily in the NOTCH1 gene). These tumors appear to behave more aggressively. Patients for whom tumor profiling has identified a NOTCH pathway alteration may wish to discuss the following studies with their physicians:
Selected Phase I Clinical Trials of NOTCH inhibitors (Updated September 2016)
Compound Targets Sponsor Locations Scientific Rationale Info Link Contact LY3039478 NOTCH Eli Lilly USA (CA, FL, MA, MI, NY, TX),
Denmark, France, Spain
Strong View 877-285-4559 or 317-615-4559
Historically, clinical trials involved only one or two treatments. Some newer trials are incorporating tumor profiling to direct patients to many more potential treatments within the same study. These “basket trials” try to match targeted drugs to genomic alterations in each patient’s particular tumor. Some of these trials profile the patient’s tumor as party of the study (NCI-MATCH) while others will suggest treatment decisions based on existing tumor profiling reports (ASCO TAPUR). The clinical trials listed below are not specifically for ACC patients, but may be worth considering in consultation with a knowledgeable physician.
“Basket” Clinical Trials Incorporating Tumor Profiling (Updated September 2016)
Compound Targets Sponsor Locations Scientific Rationale Info Link Contact NCI-MATCH Multiple targets National Cancer Institute Nearly 1,000 locations in USA Solid View View Info Link for details on each site ASCO TAPUR Multiple targets American Society of Clinical Oncology USA (MI, NC; eventually national) Solid View Pam Mangat, MS
Drug Therapies for Salivary Gland Cancers Based on Testing of Genes
(for salivary gland cancer patients, including ACC; only Canadian patients are eligible)
Multiple targets University Health Network, Toronto Toronto, Ontario, Canada Solid View Albiruni Razak, M.D.
Download Selected Clinical Trials – Currently Open (Updated September 2016)