. 2020 Jun 27;43(10):1045–1055. doi: 10.1007/s40264-020-00964-x

Table 2.

Clinical trials in which subjects received onapristone extended release (ONA-ER)

Study	Study title	Dosage and dosage subjects (n)
NCT02052128 (AR18-CT-101)^a	Phase 1–2 Study of Onapristone in Patients with Progesterone Receptor Expressing Cancers	Phase I (a) ONA-ER BID: 10, 20, 30, 40, 50 mg (n = 46) (b) ONA 100 mg QD (n = 6) Phase II (a) ONA-ER BID 50 mg (n = 6)
NCT02049190 (AR18-CT-102)^b	Phase 1–2 Study of Onapristone in Patients with Advanced Castration-resistant Prostate Cancer	(a) ONA-ER BID: 10, 20, 30, 40, 50 mg (n = 21) (b) ONA-ER 30 mg BID + abiraterone 1000 mg (n = 5)^c (c) ONA-ER 50 mg BID + abiraterone 1000 mg (n = 10)^c

Study

Study title

Dosage and dosage subjects (n)

NCT02052128 (AR18-CT-101)^a

Phase 1–2 Study of Onapristone in Patients with Progesterone Receptor Expressing Cancers

Phase I

(a) ONA-ER BID: 10, 20, 30, 40, 50 mg (n = 46)

(b) ONA 100 mg QD (n = 6)

Phase II

(a) ONA-ER BID 50 mg (n = 6)

NCT02049190 (AR18-CT-102)^b

Phase 1–2 Study of Onapristone in Patients with Advanced Castration-resistant Prostate Cancer

(a) ONA-ER BID: 10, 20, 30, 40, 50 mg (n = 21)

(b) ONA-ER 30 mg BID + abiraterone 1000 mg (n = 5)^c

BID twice daily, QD once daily

^aPhase I of NCT02052128 (AR18-CT-101) was published as Cottu et al. [9]

^bAll subjects had histologically confirmed adenocarcinoma of the prostate that had progressed on abiraterone or enzalutamide. NCT02049190 was published as Jayaram et al. [18]

^cAbiraterone acetate 1000 mg QD was dosed with prednisone 5 mg BID