A Model‐Informed Drug Development Approach to Design a Phase 3 Trial of Teverelix Drug Product in Advanced Prostate Cancer Patients with Increased Cardiovascular Risk
Chenna Keshava Reddy Sannala,
Carol MacLean,
Finn Larsen
et al.
Abstract:Teverelix drug product (DP) is a parenteral gonadotropin‐releasing hormone (GnRH) antagonist that has been successfully tested in phase 2 trials for hormone‐sensitive advanced prostate cancer (APC) and benign prostatic hyperplasia (BPH). In previous APC trials, teverelix DP was administered as intramuscular (IM) and subcutaneous (SC) injections, using a loading dose and (in a single trial) a maintenance dose. Our objective was to derive an optimal dosing regimen for phase 3 clinical development, using a pharma… Show more
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