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Oncology Clinical Trials at PNI
March 2, 2021

ONCOLOGY Clinical Trials Round-Up: March 2021

by Mini Gill

New Studies

EpicentRx Beta-Prime: A Phase I, First in Human, Study to Evaluate the Safety and Tolerability of AdAPT-001 in Subjects with Refractory Solid Tumors (NCT04673942)

Actively Recruiting Studies

Brain Cancer (Primary) – Glioma

Aadi Bioscience (PDF): A Phase 2, Open-label Study of ABI-009 (nab-Rapamycin) in Bevacizumab-naïve Patients with Recurrent High-grade Glioma and in Patients with Newly Diagnosed Glioblastoma (NCT03463265)

Oblato OKN-007 (PDF): Phase II trial investigating the efficacy, safety, and pharmacokinetic properties of OKN-007 combined with TMZ in Recurrent Glioblastoma Multiforme patients (1st relapse) (NCT04388475

Orbus Therapeutics (PDF): A Randomized Phase 3 Open-Label Study To Evaluate the Efficacy and Safety of Eflornithine With Lomustine Compared to Lomustine Alone in Patients With Anaplastic Astrocytoma That Progress/Recur After Irradiation and Adjuvant Temozolomide Chemotherapy (NCT02796261)   

PIN – PNI/SJCI JWCI-17-0801: Precision Immunotherapy in Neoadjuvant Setting – A Longitudinal Assessment of Tumor Evolution in Patients with Brain Cancer (NCT03425292)


Chordoma – PNI/JWCI (PDF): Pilot Study of Pemetrexed for the Treatment of Chordoma (NCT03955042)

Solid tumor icon illustration

Solid Tumors

Bayer (PDF): ON-TRK: PrOspective Non-interventional Study in Patients with Locally Advanced or Metastatic TRK Fusion Cancer treated with Larotrectinib (NCT03025360)

Incyte (PDF): A Phase 2, Open-Label Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants with Previously Treated Locally Advanced/Metastatic or Surgically Unresectable Solid Tumor Malignancies Harboring Activating FGFR Mutations of Translocations (FIGHT-207) (NCT03822117)

Brain Metastases

Blue Earth Diagnostics FLC-219: (PDF): An Open-label, Single-arm, Single-dose, Prospective, Multicenter Phase 2b Study to Establish Image Interpretation Criteria for 18F-Fluciclovine Positron Emission Tomography (PET) in Detecting Recurrent Brain Metastases After Radiation Therapy (PURSUE) (NCT04410367)

Quality and Outcomes Research

CIPN – PNI/SJCI JWCI-17-0101 (PDF): An Observational Study of Memantine XR (extended release) and Pregabalin Combination Therapy in Chemotherapy-Induced Peripheral Neuropathy (CIPN) (NCT03709888)

NOC – PNI/SJCI JWCI-17-0401 (PDF): Neurological Outcomes in Health and Disease

Upcoming Trials

Newly Diagnosed GBM – Trident EF-32: A Phase III Randomized, open-label study of Optune® (TTFields, 200KHZ) concomitant with radiation therapy and temozolomide for the treatment of newly diagnosed glioblastoma

Brain Tumor – Xoran: Neurosurgical Evaluation of a Mobile CT Scanner

Solid Tumor – Spectrum 107: An Open-label, Nonrandomized, Phase 1 Drug-Drug Interaction Study to Evaluate the Pharmacokinetics of Belinostat in Combination with Atazanavir in Patients with Advanced Relapsed/Refractory Solid Tumors or Hematological Malignancies 

Recurrent Brain Metastases – BED-FLC-312: An Open-label, Single-arm, Single-dose, Prospective, Multicenter Phase 3 study to Establish the Diagnostic Performance of 18F-Fluciclovine Positron Emission Tomography (PET) in Detecting Recurrent Brain Metastases after Radiation Therapy

For more information, please contact the neurosciences Clinical Trials Team at:
E-mail: or
Phone: 310-829-8265


Garni Barkhoudarian, MD
Jose Carrillo, MD
Natalie Diaz, MD
Chester Griffiths, MD
Daniel Kelly, MD
Santosh Kesari MD, PhD, FANA, FAAN
Jean-Philippe Langevin, MD
Sarah McEwen, PhD
David Merrill, MD, PhD  
Melita Petrossian, MD
Verna Porter, MD
Marlon Garzo Saria, PhD, RN
Akanksha Sharma, MD
Naveed Wagle, MD

Clinical Trials Team:

Ashley Archer, CRA
DeLisa Madere, RA
Annie Heng, RN, BSN
Raffi Nersesian, CRA

About the Author

Jaya Mini Gill, RN, BSN

Mini Gill

Jaya Mini Gill, RN, BSN is involved in all aspects of clinical trial study design and processes in the Department of Translational Neurosciences and Neurotherapeutics at the Saint John’s Cancer Institute. An experienced nurse, she is responsible for accurate protocol implementation along with the treatment, care, management, and follow-up of patients.

Last updated: April 1st, 2021