Date: 2017-02-23
Type of information: Completion of patient enrollment
phase: 2-3
Announcement: completion of patient enrollment
Company: Tocagen (USA - CA)
Product: Toca 511 & Toca FC
Action
mechanism: gene therapy. Tocagen’s lead product candidate is a combination of an investigational biologic, Toca 511, and an investigational small molecule, Toca FC, designed to be used together. The Toca 511 & Toca FC combination is designed to directly kill cancer cells and immune-suppressive myeloid cells resulting in activation of the immune system against cancer. The FDA has granted Toca 511 & Toca FC Breakthrough Therapy Designation and Fast Track designation for the treatment of patients with recurrent high grade glioma, and orphan-drug designation for the treatment of glioblastoma multiforme (GBM).
Disease: glioblastoma multiforme, anaplastic astrocytoma
Therapeutic area: Cancer - Oncology
Country: Canada, Israel, Republic of Korea, USA
Trial
details: The trial is a multicenter, randomized, open-label phase 2/3 study of Toca 511 and Toca FC versus standard of care that comprises investigator's choice of single agent chemotherapy (lomustine or temozolomide) or bevacizumab administered to subjects undergoing resection for first or second recurrence (including this recurrence) of GBM or AA. Subjects meeting all of the inclusion and none of the exclusion criteria will be randomized prior to surgery in a 1:1 ratio to receive either Toca 511 and Toca FC (Experimental arm, Arm T) or control treatment with one option of standard of care (Arm SOC). Due to the prognostic influence of molecular subgroups such as isocitrate dehydrogenase mutation, the trial will be stratified based on this determination from the primary pathology or subsequent biopsy known locally or otherwise determined centrally. A second stratification factor is based on the patient's Karnofsky Performance Score (KPS) (70-80 vs 90-100). Further, to account for potential differences in treatment choices for the control arm in regions, the trial will be stratified by geographical region during the randomization process. The study will be conducted in 2 parts; enrollment in the phase 3 will begin after phase 2 results are available. The lead investigators of the Toca 5 trial are as follows: United States: Tim Cloughesy, M.D., director of the University of California, Los Angeles, Neuro-Oncology Program; Canada: Gelareh Zadeh, M.D., Ph.D., associate professor at the Department of Surgery University of Toronto; Israel: Rachel Grossman, M.D., attending neurosurgeon at Tel-Aviv Sourasky Medical Center; South Korea: Sin-Soo Jeun, M.D., professor of neurosurgery at Seoul St. Mary’s Hospital. ( NCT02414165)
Latest
news: * On February 23, 2017, Tocagen announced it has completed patient enrollment in the Phase 2 portion of Toca 5, a randomized, international Phase 2/3 clinical trial of Toca 511 & Toca FC, for the treatment of patients with recurrent brain cancer. Toca 5 is designed to serve as a potential registrational trial, and top-line results from the Phase 2 portion are anticipated in the first half of 2018. In the trial, patients with first or second recurrence of glioblastoma or anaplastic astrocytoma who are undergoing resection are randomized between a cancer-selective virus and oral prodrug, Toca 511 & Toca FC, or standard of care. The primary endpoint of the Toca 5 clinical trial is overall survival. Secondary endpoints include objective response rate and duration of response. Immune monitoring is being performed to evaluate evidence of immunologic mechanisms of disease control. A total of 67 clinical sites around the world are participating in the trial. Investigators chose between chemotherapy (lomustine or temozolomide) or antiangiogenic therapy (bevacizumab) for the control arm.
