Table 1.

Current rucaparib trials in ovarian cancer and other disease types

Trial	Phase	Disease site and setting	Groups	Primary and secondary outcomes evaluated	Status
ATHENA	Phase III randomized double-blind placebo-controlled 4-arm study of rucaparib with or without nivolumab	Maintenance following a response to front-line treatment in newly diagnosed patients with stage III or IV ovarian cancer (including patients with fallopian tube or primary peritoneal cancer)	A: Oral rucaparib twice daily and IV nivolumab every 4 weeks B: Oral rucaparib and IV placebo C: Oral placebo and IV nivolumab; D: Oral placebo and IV placebo	1° outcome: investigator-assessed PFS 2° outcomes: blind-independent central review (BICR) PFS, OS, ORR, and DOR, safety and tolerability of the drug	Recruiting
ARIEL4	Phase III, open label, randomized trial of rucaparib vs chemotherapy for BRCA mutation carriers	Treatment for relapsed high grade serous or endometrioid ovarian, fallopian tube, or primary peritoneal cancer	A: Oral rucaparib twice daily B: Chemotherapy (per local standard of care and regulations)	1° outcome: PFS by RECIST 2° outcomes: OS, safety and tolerability	Recruiting
TRITON2	Phase II, open label, single-arm trial of rucaparib in metastatic castration-resistant prostate cancer associated with HRD	Treatment for progressive, metastatic castration-resistant prostate cancer associated with HRD, after receiving 1–2 androgen receptor-targeted therapies and 1 prior taxane-based chemotherapy. Participants must have a mutation in BRCA1/2, ATM, or other evidence of HRD	A: Oral rucaparib daily	1° outcome: ORR, PSA response 2° outcomes: DOR, radiologic PFS, OS, time to PSA progression, trough plasma pharmacokinetics, safety and tolerability	Recruiting
TRITON3	Phase III, open label, randomized trial of rucaparib vs physician’s choice therapy for metastatic castration-resistant prostate cancer associated with HRD	Treatment for disease progression of metastatic, castration-resistant prostate cancer, associated with HRD (patients must have BRCA1/2 or ATM gene mutation) and have experienced disease progression after 1 prior next generation androgen receptor-targeted therapy	A: Oral rucaparib daily B: Abiraterone acetate, enzalutamide, or docetaxel	1° outcome: radiological PFS 2° outcomes: ORR, DOR, radiologic PFS, OS, time to PSA progression, trough plasma pharmacokinetics of drug, safety and tolerability changes in patient reported outcome, CBR, OS	Recruiting
ATLAS	Phase II, open label trial in locally advanced or metastatic urothelial carcinoma	Treatment for locally advanced or metastatic breast cancer	A: Oral rucaparib daily	1° outcome: ORR 2° outcomes: DOR, PFS, safety and tolerability, trough plasma pharmacokinetics of drug	Recruiting
Rucaparib with atezolizumab in advanced gynecologic cancers or triple- negative breast cancer	Phase Ib, open-label, non- randomized trial in previously treated ovarian or endometrial cancer (part 1) and platinum- sensitive ovarian cancer or triple negative breast cancer (part 2)	Treatment for recurrent endometrial or ovarian cancer after 1 prior line of therapy for part 1 and for part 2 s/gBRCAmut or LOH high tumor with platinum-sensitive recurrence after 1–2 lines of therapy including a platinum. For the TNBC cohort, the disease must have recurred after 1 line of chemotherapy	Dose-finding phase: oral rucaparib twice daily with atezolizumab every 21 days Dose-expansion phase: cohort 1 (ovarian cancer): rucaparib monotherapy Cohort 2 (TNBC) rucaparib twice daily and IV atezolizumab every 21 days	1° outcome: safety and tolerability, percentage of people with DLTs, R2PD for the combination, number of dose modifications 2° outcomes: CR, PR, DOR, PFS as per RECIST and iRECIST, OS, For rucaparib: steady state maximum plasma concentration and time to maximum plasma concentration, area under the plasma-concentration-time curve, apparent clearance, minimum plasma concentration during the dosing interval, and serum concentration of atezolizumab	Recruiting

Abbreviations: CBR, clinical benefit rate (defined as CR); DLT, dose-limiting toxicities; DOR, duration of response; HRD, homologous recombination deficiency; LOH, loss of heterozygosity; ORR, objective response rate; OS, overall survival; PFS, progression-free survival; PSA, prostate specific antigen; R2PD, recommended phase II dose; RCT, randomized-controlled trial; RECIST, Response Evaluation Criteria in Solid Tumors v1.1; TNBC, triple negative breast cancer; iRECIST, immune-modified RECIST incorporating immune response; s/gBRCAmut, somatic/germline BRCA mutation.