Del Mar Pharmaceuticals has filed an investigational new drug (IND) application with the United States FDA to conduct clinical trials with VAL-083 in patients diagnosed with glioblastoma multiforme. We are in the process of responding to the FDA’s questions on our application and anticipate initiating the clinical trial during the coming months.
Please check back to this page for updates. Study site and enrollment information will be provided here upon approval of our trial by the FDA.
Del Mar Pharma has initiated a clinical trial with its lead drug candidate VAL-083 for the treatment of refractory glioblastoma multiforme (GBM). The Phase I/II study is an open-label, single arm dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of VAL-083 in patients with histologically confirmed initial diagnosis of primary WHO Grade IV malignant glioma (GBM), now recurrent. Patients with prior low-grade glioma or anaplastic glioma are eligible, if histologic assessment demonstrates transformation to GBM.
Patients must have been previously treated for GBM with surgery and/or radiation, if appropriate, and must have failed both Bevacizumab (Avastin(r)) and temozolomide (Temodar(r)), unless either or both are contra-indicated.
Response to therapy and disease progression will be evaluated by MRI prior to each treatment cycle. An initial phase of the study will involve dose escalation cohorts until a maximum tolerated dose (MTD) is established in the context of modern care. Once the modernized dosing regimen has been established, additional patients will be enrolled at the MTD (or other selected optimum dosing regimen).
The study is being conducted under the direction of Dr. Howard Burris at the Sarah Cannon Research Institute in Nashville, Tennessee.
Further details and information about the clinical centers conducting the study can be found at clinicaltrails.gov.