Clinical Trials

Although Van Andel Research Institute does not treat patients, it does support clinical trials through two of its collaborations—the Van Andel Research Institute–Stand Up To Cancer Epigenetics Dream Team and Linked Clinical Trials initiative, which is spearheaded along with The Cure Parkinson’s Trust.

Clinical trials are a critical—and required—step on the road from a lab discovery to use in patient care. These rigorously designed studies ensure that new therapies are safe and effective.

Learn more about these efforts by browsing below. Specific information on the trials, including locations, contact information and inclusion/exclusion criteria, is available by visiting the ClincialTrials.gov link listed with each trial.

Cancer Trials

Metastatic colorectal cancer

Metastatic colorectal cancer
Metastatic colorectal cancer is the second leading cause of cancer death in men and women combined in the U.S.

What is being tested?
Resistance is a common problem in cancer treatment. It occurs when a person’s cancer stops responding to existing medications and therapeutic strategies. This trial investigates whether combining an epigenetic drug called guadecitabine with a standard treatment, irinotecan, can reverse resistance to irinotecan.

Trial details
Trial name: Phase I study of SGI-110 with irinotecan followed by randomized phase II study of SGI-110 with irinotecan versus regorafenib or TAS-102 in previously treated metastatic colorectal cancer
ClinicalTrials.gov numberNCT01896856
Status: Currently recruiting
Trial locations:

  • Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland
  • University of Southern California, Los Angeles, California
  • Memorial Sloan Kettering Cancer Center, New York, New York
  • VU University Medical Center, Amsterdam, The Netherlands

Industry partner: Astex Pharmaceuticals, Inc. 

For a list of inclusion and exclusion criteria and contact information for individual trial sites, please visit clinicaltrials.gov here.

Acute myeloid leukemia

Acute myeloid leukemia (relapsed and refractory)
AML is an aggressive cancer that begins as abnormal blood cells in the bone marrow, and can spread throughout the circulatory system and beyond. Almost 20,000 people in the U.S. are diagnosed with AML each year. Long-term survival with AML is poor and treatment approaches have remained largely unchanged for decades.

What is being tested?
The trial pairs an investigational drug, talazoparib, with decitabine, an epigenetic drug that is already approved for use in myelodysplastic syndrome, a disease that often precedes AML. Preclinical studies show the combining the drugs may maximize their ability to kill cancer cells.

Trial Details
Trial name: Decitabine and talazoparib in untreated AML and R/R AML
ClinicalTrials.gov number: NCT02878785
Status: Currently recruiting
Trial locations:

  • University of Maryland Greenebaum Comprehensive Cancer Center, Baltimore, Maryland
  • Other sites expected to open soon

For a list of inclusion and exclusion criteria and contact information for individual trial sites, please visit clinicaltrials.gov here.

Myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML)

Myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML)
An estimated 13,000 people in the U.S. are diagnosed with MDS annually and about 20,000 are diagnosed with AML. Currently, only about half of patients with MDS and AML respond to the current epigenetic therapy alone.

What is being tested?
This small pilot study is investigating whether a simple tweak to the standard care regimen may improve the current treatment’s ability to impede cancer cell growth and destroy cancer cells.

Trial details
Trial name: Epigenetics, vitamin C and abnormal hematopoiesis
ClinicalTrials.gov number: NCT02877277
Trial location: Rigshospitalet, University of Copenhagen, Denmark

For a list of inclusion and exclusion criteria and contact information for individual trial sites, please visit clinicaltrials.gov here.

Please note, maintaining proper nutrition is an important part of cancer therapy. Patients are urged to consult their doctors before making any change to their nutrition or vitamin regimen.

Myelodysplastic syndrome (MDS) and chronic myelomonocytic leukemia (CMML)

Myelodysplastic syndrome (MDS) and chronic myelomonocytic leukemia (CMML)
An estimated 13,000 people in the U.S. are diagnosed every year with MDS and an additional 1,100 are diagnosed with CMML. Both conditions are incurable with current drugs, and both can progress to acute myeloid leukemia (AML), a lethal blood cancer that accounts for more than 10,000 deaths every year.

What is being tested?
The trial studies the combination of an investigational epigenetic drug called guadecitabine with atezolizumab, a cancer immunotherapy medicine. Laboratory results show these drugs synergize to help the body’s immune system recognize and destroy cancer.

Trial details
Trial name: Guadecitabine and atezolizumab in treating patients with advance myelodysplastic syndrome or chronic myelomonocytic leukemia that is refractory or relapsed
ClinicalTrials.gov number: NCT02935361
Status: Recruiting (please see location specific information below)
Trial locations:

  • University of Southern California/Norris Comprehensive Cancer Center, Los Angeles, California (recruiting)
  • University of Maryland, Baltimore, Maryland (not yet recruiting)
  • Fox Chase Cancer Center, Philadelphia, Pennsylvania (not yet recruiting)

Industry partners: Astex Pharmaceuticals and Genentech, a member of the Roche Group

For a list of inclusion and exclusion criteria and contact information for individual trial sites, please visit clinicaltrials.gov here.

Non-small cell lung cancer

Non-small cell lung cancer                                                                          
Lung cancer is a major public health problem and claims more lives annually than any other type of cancer. Its most common subtype is non-small cell lung cancer, which accounts for over 80 percent of the estimated 290,000 cases of lung cancer expected to be diagnosed in the U.S. in 2017.

What is being tested?
This trial combines two epigenetic drugs—guadecitabine (Astex Pharmaceuticals) and mocetinostat (Mirati Therapeutics)—with the immunotherapy drug pembrolizumab (Keytruda®; Merck) to make cancer cells more visible to attack by the immune system’s natural defenses.

Trial details
Trial name: Phase I/Ib study of combined pembrolizumab plus guadecitabine and mocetinostat for patients with advanced NSCLC (supported by the SU2C Catalyst ®)
ClinicalTrials.gov identifier: NCT03220477
Status: Not yet open for participant recruitment
Estimated enrollment: 57
Trial locations:

  • Memorial Sloan Kettering Cancer Center in New York, New York (enrolling)
  • Fox Chase Cancer Center in Philadelphia, Pennsylvania
  • Johns Hopkins University Sidney Kimmel Comprehensive Cancer Center and Bloomberg-Kimmel Institute for Cancer Immunotherapy in Baltimore, Maryland

Industry partners: Merck & Co., Inc., Kenilworth, NJ, USA (known as MSD outside the U.S. and Canada) through its subsidiary Merck Sharp & Dohme, Corp.; Mirati Therapeutics; Astex Pharmaceuticals

For a list of inclusion and exclusion criteria and contact information for individual trial sites, please visit clinicaltrials.gov here.

Bladder (urothelial) cancer

Bladder (urothelial) cancer
Bladder cancer is the sixth most common type of cancer. An estimated 79,000 people are expected to be diagnosed in the U.S. alone during 2017.

What is being tested?
This trial will investigate whether guadecitabine (Astex Pharmaceuticals) can epigenetically reprogram tumors, reversing the resistance of bladder cancers to the immunotherapy drug atezolizumab (Tecentriq®; Genentech).

Trial details
Trial name: Overcoming atezolizumab resistance with epigenetic therapy in urothelial cancer (supported by the SU2C Catalyst®)
ClinicalTrials.gov identifier: NCT03179943
Status: Not yet open for participant recruitment
Estimated enrollment: 53 patients
Sites:

  • Fox Chase Cancer Center in Philadelphia, Pennsylvania
  • University of Southern California in Los Angeles, California
  • Johns Hopkins University Sidney Kimmel Comprehensive Cancer Center in Baltimore, Maryland

Industry partners: Genentech, a member of the Roche Group; and Astex Pharmaceuticals

For a list of inclusion and exclusion criteria and contact information for individual trial sites, please visit clinicaltrials.gov here.

Parkinson's Disease Trials

Please note, this list only includes ongoing clinical trials. For more information on other drugs prioritized for clinical trials through Linked Clinical Trials, please visit our LCT page here.

Ambroxol

Ambroxol
Ambroxol is currently approved to treat respiratory ailments. Lab studies have shown that it improves the function of a protein that plays a key role in cellular “trash removal.” Breakdowns in these processes are thought to be associated with neurodegenerative disease onset and progression. 

Trial details
Trial name: Ambroxol in disease modification in Parkinson’s disease (AiM-PD)
ClinicalTrials.gov number: NCT02941822
Status: Not yet open for participant recruitment
Trial location: Leonard Wolfson Experimental Neurology Clinical Research Facility (London, United Kingdom)

For a list of inclusion and exclusion criteria and contact information for individual trial sites, please visit clinicaltrials.gov here.

Liraglutide

Liraglutide
Liraglutide is a type 2 diabetes medication. It belongs to a class of drugs called GLP-1 agonists and prompts the release of insulin, thereby lowering glucose levels in the blood when bound to its receptor. Recent laboratory findings suggest that when liraglutide activates these receptors in the brain, the drug provides protection against degenerative damage to key brain cells, specifically those affected in Parkinson’s disease.

Trial details
Trial name: Safety and efficacy of liraglutide in Parkinson’s disease
ClinicalTrials.gov number: NCT02953665
Status: Currently recruiting
Trial location: Cedars-Sinai Medical Center (Los Angeles, California)

For a list of inclusion and exclusion criteria and contact information for individual trial sites, please visit clinicaltrials.gov here.