ONCOLOGY Clinical Trials Round-Up: March 2021

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)

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Actively Recruiting Studies

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Brain Cancer (Primary) – Glioma

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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)

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Solid Tumors

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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)

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Brain Metastases

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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)

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Quality and Outcomes Research

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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

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Upcoming Trials

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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: Neuro.Oncology@jwci.org or Neuro.Trials@pacificneuro.org
Phone: 310-829-8265

Investigators:

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 ArcherA@jwci.org 310-582-7460	DeLisa Madere, RA  Delisa.Madere@providence.org 310-449-5271
Annie Heng, RN, BSN Annie.Heng@providence.org 310-582-7457	Raffi Nersesian, CRA  Raffi.Nersesian@providence.org 310-829-8808