Amplia Therapeutics (ASX:ATX) said the US Food and Drug Administration said that its proposed changes to a study of FAK inhibitor narmafotinib, in combination with the chemotherapy regime FOLFIRINOX, in advanced pancreatic cancer patients "appear reasonable," according to a Monday Australian bourse filing.
The firm sought feedback from the regulator regarding the proposed changes, including those related to the dose-escalation and dose-optimization phase of the study and concerning the removal of a pharmacokinetic assessment of FOLFIRINOX in the trial.
The nod will allow the firm to finalize the study protocol and initiate the final stages of trial planning.
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