Phase II – Adults With Recurrent H3 K27M High-grade Glioma (NCT03295396)
The trial, identified as NCT03295396 on www.clinicaltrials.gov, is entitled “A Phase II, Open-label Study of ONC201 in Adults With Recurrent High-grade Glioma.” The primary objective of this phase II trial is to determine the efficacy and safety of ONC201, an oral small molecule imipridone DRD2 antagonist, in adult subjects with recurrent high-grade glioma. This study will test the research hypothesis that histone H3 K27M mutation sensitizes to oral administration of ONC201 in gliomas. Andrew S. Chi, Md, PhD, chief of neuro-oncology and the codirector of the Brain Tumor Center at NYU Langone, is the Principal Investigator for the trial.
Phase I – Solid Tumors (NCT02250781)
The first clinical trial of ONC201 began in January 2015 at Rutgers Cancer Institute of New Jersey. The trial, identified as NCT02250781 on www.clinicaltrials.gov, is entitled “Oral ONC201 in Treating Patients with Advanced Solid Tumors.” The Phase I trial is investigating the use of ONC201 in patients with solid tumors not amenable to treatment with standard chemotherapy. The trial is being led by Mark Stein, MD, a medical oncologist and member of the Phase I/Investigational Therapeutics Program at the Cancer Institute of New Jersey. Dose escalation and expansion cohorts have been completed, treating a total of 28 patients. Subsequent to the completion of the expansion cohort, a dose intensification cohort has been initiated and is enrolling patients on a weekly dosing schedule.
Phase I/II – Leukemia (NCT02392572)
Phase I/II – Lymphoma (NCT02420795)
Under a strategic alliance and research collaboration agreement for the clinical development of ONC201, The University of Texas MD Anderson Cancer Center announced the initiation of two clinical trials in January 2015. The strategic alliance provides for a sharing of risk and potential commercialization of ONC201 and is expected to enroll approximately 50 patients with acute leukemias and 50 patients with non-Hodgkin lymphomas. The first trial, identified as NCT02392572 on www.clinicaltrials.gov, is entitled “Phase I/II Study of Oral ONC201 in Patients with Relapsed/Refractory Acute Leukemias and High-Risk Myelodysplastic Syndromes.” The Phase I/II trial is investigating the use of ONC201 in patients with relapsed or refractory acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), and myelodysplastic syndrome (MDS). Gautam Borthakur, MD, Associate Professor in the Department of Leukemia at MD Anderson Cancer Center, is the Principal Investigator for the trial. The second trial, identified as NCT02420795 on www.clinicaltrials.gov, is entitled “Study of Oral ONC201 in Patients With Relapsed/Refractory Non-Hodgkin’s Lymphoma.” The Phase I/II trial is investigating the use of ONC201 in patients with relapsed or refractory mantle cell lymphoma (MCL), cutaneous T-cell lymphoma (CTCL), diffuse large B-cell lymphoma (DLBCL) and transformed large cell lymphoma (TLCL). Michael Wang, MD, Professor in the Department of Lymphoma/Myeloma at MD Anderson Cancer Center, is the Principal Investigator for the trial.
Phase II – GBM (NCT02525692)
With support from an Small Business Innovation Research (SBIR) grant from the National Institutes of Health awarded to Oncoceutics in 2015, the company has initiated a Phase II clinical trial investigating the use of ONC201 in patients with relapsed or refractory glioblastoma multiforme (GBM). Isabel Arrillaga-Romany, MD, PhD, Associate Clinical Director of Neuro-Oncology at Massachusetts General Hospital, and Patrick Wen, MD, Director of the Center for Neuro-Oncology at the Dana Farber Cancer Institute, are the Principal Investigators for the trial.
Phase I – Solid Tumors and Multiple Myeloma (NCT02609230)
This clinical trial is evaluating the safety and pharmacodynamics of different ONC201 administration schedules in patients with advanced solid tumors or multiple myeloma. Anthony Olszanski, MD, Director of Clinical Drug Development at Fox Chase Cancer Center, is the Principal Investigator for the trial.
Phase II– Multiple Myeloma (NCT02863991)
This clinical trial is evaluating ONC201 in patients with relapsed/refractory multiple myeloma. Henry Fung, MD, Vice-Chair, Department of Hematology/Oncology, is the Principal Investigator for the trial.
Phase II – Endometrial Cancers (NCT03099499)
This clinical trial is evaluating ONC201 in patients with recurrent or metastatic endometrial cancer. Dr. Gina Mantia-Smaldone is the Principal Investigator for the trial.