Thursday, 29 June 2017

Expanded Access to VAL-083

https://clinicaltrials.gov/ct2/show/NCT03138629

"This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to VAL-083 (dianhydrogalactitol) prior to approval by the local regulatory agency. Availability will depend on territory eligibility. Participating sites will be added as they apply for and are approved for the EAP. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria."

There is also an upcoming phase 3 clinical trial that will test VAL-083 for recurrent GBM that failed Avastin.

https://clinicaltrials.gov/ct2/show/NCT03149575


2 comments:

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    1. http://www.delmarpharma.com/DELMARPHARMA%20SNO%202015%20clinical%20-%2044x44%20-%20FINAL.pdf

      At the dose of 40 mg/m2 which is being used in the phase 3 trial, toxicities were mild, with only grade 1 hematological toxicity observed (2 out of 3 patients at this dose level had grade 1 thromboxytopenia (low platelets).

      At 50 mg/m2 toxicities were more prevalent and more severe.

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