ODM-204 / Orion Corp - LARVOL DELTA

ODM-204 a novel dual inhibitor of CYP17A1 and androgen receptor: Early results from phase I dose escalation in men with castration-resistant prostate cancer. (ASCO-GU 2017) - P1/2; "Although evidence of anticancer activity was provided with ODM-204 in mCRPC, decreasing steady state concentration was observed."

P1 data • Prostate Cancer

ODM-204, a Novel Dual Inhibitor of CYP17A1 and Androgen Receptor: Early Results from Phase I Dose Escalation in Men with Castration-resistant Prostate Cancer. (PubMed, Eur Urol Focus) - "ODM-204 was well tolerated up to the highest evaluated dose. There were decreases in both testosterone and PSA levels, suggesting preliminary antitumour activity in the treatment of CRPC. The pharmacokinetic properties of the molecule, however, prevent further development."

Journal • P1 data • Fatigue • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • AR • CYP17A1

Predicting the effect of prandial stage and particle size on absorption of ODM-204. (PubMed, Eur J Pharm Biopharm) - "The models examined provided congruent data on dose dependent absorption, food effect at a dose of 200 mg and on the effect of API (active pharmaceutical ingredient) particle size on absorption. Our study shows that the predictive tools of in vitro dissolution, TIM-1 system and the PBPK (physiologically based pharmacokinetic modelling) simulation, showed predictive power of different mechanisms of bioavailability and together provided valuable information for decision making."

Journal • AR • CYP17A1 • KIM1

Discovery and Development of ODM-204: A Novel Nonsteroidal Compound for the Treatment of Castration-Resistant Prostate Cancer by blocking the Androgen Receptor and Inhibiting CYP17A1. (PubMed, J Steroid Biochem Mol Biol) - "In rats, leuprolide acetate-mediated (LHRH agonist) suppression of the circulating testosterone levels and decrease in weights of androgen-sensitive organs was significantly and dose-dependently potentiated by the co-administration of ODM-204. ODM-204 was well tolerated in both rodents and primates. Based on our data, ODM-204 could provide an effective therapeutic option for men with CRPC."

Journal • Review

DUALIDES: Safety and Pharmacokinetics of ODM-204 in Patients With Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov) - P1/2; N=23; Completed; Sponsor: Orion Corporation, Orion Pharma; N=75 ➔ 23

Clinical • Enrollment change • KLK3

DUALIDES: Safety and Pharmacokinetics of ODM-204 in Patients With Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov) - P1/2; N=75; Active, not recruiting; Sponsor: Orion Corporation, Orion Pharma; Recruiting ➔ Active, not recruiting; Trial primary completion date: May 2017 ➔ Dec 2017

Clinical • Enrollment closed • Trial primary completion date

DUALIDES: Safety and Pharmacokinetics of ODM-204 in Patients With Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov) - P1/2; N=75; Recruiting; Sponsor: Orion Corporation, Orion Pharma; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

DUALIDES: Safety and Pharmacokinetics of ODM-204 in Patients With Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov) - P1/2; N=75; Not yet recruiting; Sponsor: Orion Corporation, Orion Pharma

Clinical • New P1/2 trial

DUALIDES: Safety and Pharmacokinetics of ODM-204 in Patients With Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov) - P1/2; N=75; Completed; Sponsor: Orion Corporation, Orion Pharma; Active, not recruiting ➔ Completed

Clinical • Trial completion

DUALIDES: Safety and Pharmacokinetics of ODM-204 in Patients With Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov) - P1/2; N=75; Active, not recruiting; Sponsor: Orion Corporation, Orion Pharma; Trial completion date: Dec 2017 ➔ Dec 2018; Trial primary completion date: Dec 2017 ➔ Dec 2018

Clinical • Trial completion date • Trial primary completion date