Dr. Akanksha Sharma, Principal Investigator, Oversees Open Brain Tumor Clinical Trials
Dr. Akanksha Sharma of the Pacific Neuroscience Institute and Saint John’s Cancer Institute is the principal investigator for clinical trials for solid tumors and Brain Cancer. Dr. Sharma is Assistant Professor of Neuro-Oncology and Translational Neurosciences. Her research is at the cutting-edge for understanding brain cancers and metastasis.
Transforming biomedical research and medicine into promising new treatments used clinically starts here at Saint John’s Cancer Institute.
Ongoing Trials for Brain Tumors, Neuroscience
Study of Subjects with Non-Small Cell Lung Cancer With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors (SPARTA)
Advancing precision medicine for patients
Summary:
c-Met can promote the development and progression of multiple cancers such as liver, lung, colon, breast, pancreatic, ovarian, prostate, and gastric carcinomas, in addition to cancers of the nervous system such as glioblastoma.
The primary phase 1 purpose of this study was to assess overall safety, tolerability and recommended Phase 2 dose.
This is a Phase 1/2, multi-center, global, open-label, 2-part study with a Dose Escalation Segment and Dose and Disease Expansion Cohorts study.
Trial Objective:
The objective is to develop and implement Phase 2. This portion will assess efficacy of the dose determined in phase 1 in individuals with Non-Small Cell Lung Cancer with c-Met EXON 14. Individuals with cancers associated with c-Met amplifications; individuals with cancers associated with c-Met fusion mutations.
Estimated number of participants: 344
Start Date: September 2017
End Date: March 2026
Conclusion of the study: November 2026
Link to Study at clinicaltrials.gov
Diffuse Glioma Following Radiotherapy (the ACTION Study)
Advancing precision medicine for patients
Summary:
This is a randomized, double-blind, placebo-controlled, parallel-group, international, Phase 3 study in patients with newly diagnosed H3 K27M-mutant diffuse glioma to assess whether treatment with ONC201 following frontline radiotherapy will extend overall survival and progression-free survival in this population. Eligible participants will have histologically diagnosed H3 K27M-mutant diffuse glioma and have completed standard frontline radiotherapy.
Trial Objective:
To look at overall survival and progression free survival in patients who are taking ONC201 versus placebo.
Estimated number of participants: 450
Start Date: January 23, 2023
End Date: August 2026
Conclusion of the study: August 2026
Link to Study at clinicaltrials.gov
Pivotal, Randomized, Open-label Study of Optune® (Tumor Treating Fields) Concomitant With RT & TMZ for the Treatment of Newly Diagnosed GBM (EF-32)
Advancing precision medicine for patients
Summary:
Pivotal, Randomized, Open-label Study of Optune® (Tumor Treating Fields) Concomitant with radiation therapy & temozolomide for the Treatment of Newly Diagnosed Glioblastomas (EF-32).
Trial Objective:
To test the effectiveness and safety of Optune® given concomitantly with radiation therapy (RT) and temozolomide (TMZ) in newly diagnosed Glioblastoma (GBM) patients, compared to radiation therapy and temozolomide alone. In both arms, Optune® and maintenance temozolomide are continued following radiation therapy.
Optune® is a medical device that has been approved for the treatment of recurrent and newly diagnosed glioblastoma (GBM) by the Food and Drug Administration (FDA) in the United States. Optune® has obtained a CE mark in Europe for recurrent and newly diagnosed GBM.
Estimated number of participants: 950
Start Date: December 8, 2020
End Date: August 2024
Conclusion of the study: August 2026
Link to Study at clinicaltrials.gov
Intermediate-size Expanded Access to ONC201 for Patients With H3 K27M-mutant and/or Midline Gliomas.
Advancing precision medicine for patients
Summary:
This is an intermediate-size expanded access protocol to provide ONC201 to patients with H3 K27M-mutant and/or midline gliomas who cannot access ONC201 through clinical trials.
Estimated number of participants: Intermediate-size Population
Start Date: Expanded Access
Link to Study at clinicaltrials.gov
Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Previously Treated Glioblastoma or Other Primary Central Nervous System Tumors Harboring Activating FGFR1-3 Alterations (FIGHT-209).
Advancing precision medicine for patients
Summary:
This is an open-label, monotherapy study in participants with recurrent glioblastoma (GBM) or other recurrent gliomas, circumscribed astrocytic gliomas, and glioneuronal and neuronal tumors with an activating FGFR1-3 mutation or fusion/rearrangement.
Trial Objective:
This study consists of 2 cohorts, Cohorts A, and B, and will enroll approximately 82 participants into each cohort. Participants will receive pemigatinib 13.5 mg QD on a 2-week on-therapy and 1-week off-therapy schedule as long as they are receiving benefit and have not met any criteria for study withdrawal.
Estimated number of participants: 164
Start Date: May 2022
End Date: January 2026
Conclusion of the study: January 2026
Link to Study at clinicaltrials.gov
Principal Investigator:
Associate Professor, Neuro-Oncology
Translational Sciences
Pacific Neuroscience Institute
Saint John’s Cancer Institute
The Saint John’s Cancer Institute maintains a robust biospecimen tissue bank and has demonstrated sustained scientific quality, resources, and storage systems for the effective management of human tissues.