| Trial name or title | A study of rucaparib as switch maintenance following platinum‐based chemotherapy in patients with platinum‐sensitive, high‐grade serous or endometrioid epithelial ovarian, primary peritoneal or fallopian tube cancer (ARIEL3) |
| Methods | Phase 3 study of rucaparib as switch maintenance after platinum in relapsed high‐grade serous and endometrioid ovarian cancer |
| Participants | Women with high‐grade serous or endometrioid epithelial ovarian, primary peritoneal or fallopian tube cancer Received ≥ 2 prior platinum‐based treatment regimens Received no more than 1 non‐platinum regimen Must have had at least a 6‐month disease‐free period following prior treatment with platinum‐based chemotherapy and achieved a response Have sufficient archival tumour tissue for analysis |
| Interventions | Rucaparib Oral tablets or placebo administered twice daily with 28‐day cycles of treatment until evidence of recurrence |
| Outcomes | Disease progression according to RECIST version 1.1 Disease progression according to RECIST version 1.1, as assessed by Independent Radiology Review (IRR), or death from any cause (irrPFS), in molecularly defined subgroups Quality of life: time to a specified decrease in the DSR P subscale of the FOSI‐18 patient‐reported outcome questionnaire; time to a specified decrease in the total score of the FOSI‐18 patient‐reported outcome questionnaire Overall survival (OS) Incidence of adverse events (AEs), clinical laboratory abnormalities and dose modifications Individual model parameter estimates of rucaparib and covariates identification (PK) |
| Starting date | January 2014 |
| Contact information | clovistrials@emergingmed.com |
| Notes | estimated completion November 2016; Last updated 23 March 2015; Date last accessed 7 April 2015 |
po: orally RECIST: Response Evaluation Criteria in Solid Tumours