Amplia Therapeutics Ltd (ASX:ATX) has begun pre-Investigational New Drug (pre-IND) interaction and discussion with the United States Food and Drug Administration (FDA) Division of Oncologic Diseases.
The company sought feedback from the FDA on development plans for a clinical trial investigating Amplia’s focal adhesion kinase inhibitor, AMP945, in people with pancreatic cancer.
This study would assess the use of AMP945 in first-line patients with advanced pancreatic cancer and is scheduled to begin recruiting in the current quarter.
The FDA advised Amplia that the general design of the trial, including selection of the first-line patient population and the proposed dose-escalation followed by a Simon 2-stage design, is generally acceptable, but recommended further pharmacokinetic sampling to more thoroughly interrogate patient exposures to AMP945, gemcitabine and nab-paclitaxel.
These recommendations will be implemented – along with any additional assessments by the FDA – in full without risking delays to the trial.
“Timely and helpful feedback”
“We are very pleased to receive FDA’s timely and helpful feedback. This pre-IND advice provides early insight into FDA’s priorities and equips us to address these proactively,” Amplia Therapeutics CEO and managing director Dr John Lambert said.
“It also allows us to enter our planned clinical study reassured that our intent to bring first-line patients into the trial is reasonable and acceptable.”
The FDA also confirmed Amplia’s understanding that dose selection for the Simon 2-stage expansion phase of the trial should be based on a combined view of safety, efficacy, pharmacokinetics (drug absorption, distribution, metabolism, and excretion), and pharmacodynamics (a drug's molecular, biochemical, and physiologic effects or actions) across a wide range of doses.
Amplia has previously secured an Orphan Drug Designation (ODD) from the FDA covering the use of AMP945 in the treatment of patients with pancreatic cancer. An ODD grants seven years exclusivity and a waiver of FDA fees.