Phase 3
Completed N=349
ARIEL4: A Study of Rucaparib Versus Chemotherapy BRCA Mutant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Patients
Source: ClinicalTrials.gov NCT02855944 ↗Enrolled (actual)
349
Serious AEs
24.5%
Results posted
Feb 2022
Primary outcomePrimary: Investigator Assessed Progression-Free Survival (invPFS) by RECIST Version 1.1 for Rucaparib Versus Chemotherapy (Efficacy Population) — 7.4; 5.7 Months — p=0.0010
◆ Published Evidence
Highly cited
143citations · ~36 / year
Rucaparib versus standard-of-care chemotherapy in patients with relapsed ovarian cancer and a deleterious BRCA1 or BRCA2 mutation (ARIEL4): an international, open-label, randomised, phase 3 trial.
Summary
The purpose of this study is to determine how patients with ovarian, fallopian tube, and primary peritoneal cancer will best respond to treatment with rucaparib versus chemotherapy.
Linked Publications (2)
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Rucaparib versus standard-of-care chemotherapy in patients with relapsed ovarian cancer and a deleterious BRCA1 or BRCA2 mutation (ARIEL4): an international, open-label, randomised, phase 3 trial.
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Rucaparib versus chemotherapy for treatment of relapsed ovarian cancer with deleterious BRCA1 or BRCA2 mutation (ARIEL4): final results of an international, open-label, randomised, phase 3 trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Investigator Assessed Progression-Free Survival (invPFS) by RECIST Version 1.1 for Rucaparib Versus Chemotherapy (Efficacy Population) |
7.4; 5.7 | 0.0010 sig |
| PRIMARY Investigator Assessed Progression-Free Survival (invPFS) by RECIST Version 1.1 for Rucaparib Versus Chemotherapy (ITT Population) |
7.4; 5.7 | 0.0017 sig |
| SECONDARY Investigator Assessed Overall Response Rate (ORR) by RECIST v1.1 (Efficacy Population) |
40.3; 32.3 | — |
| SECONDARY Investigator Assessed Overall Response Rate (ORR) by RECIST v1.1 (ITT Population) |
37.9; 30.2 | — |
| SECONDARY Investigator Assessed Duration of Response (DOR) by RECIST v1.1 (Efficacy Population) |
9.4; 7.2 | 0.0401 sig |
| SECONDARY Investigator Assessed Duration of Response (DOR) by RECIST v1.1 (ITT Population) |
9.4; 7.2 | 0.0240 sig |
| SECONDARY Investigator Assessed Overall Response Rate (ORR) by RECIST v1.1 and/or CA-125 Response (Efficacy Population) |
50.7; 43.6 | — |
| SECONDARY Investigator Assessed Overall Response Rate (ORR) by RECIST v1.1 and/or CA-125 Response (ITT Population) |
47.8; 40.5 | — |
| SECONDARY Least Squares Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status Score for the First 6 Cycles (Efficacy Population) |
0.5; 0.3 | — |
| SECONDARY Least Squares Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status Score for the First 6 Cycles (ITT Population) |
0.6; 0.4 | — |
| SECONDARY Overall Survival (Efficacy Population) |
21.1; 26.2 | — |
| SECONDARY Overall Survival (ITT Population) |
19.4; 25.4 | — |
Eligibility Criteria
Inclusion Criteria
- Be 18 years of age at the time the informed consent form is signed
- Have a histologically confirmed diagnosis of high-grade serous or Grade 2 or Grade 3 endometrioid epithelial ovarian, fallopian tube, or primary peritoneal cancer
- Received ≥ 2 prior chemotherapy regimens and have relapsed or progressive disease as confirmed by radiologic assessment
- Have biopsiable and evaluable disease. Note: biopsy is optional for patients known to harbor a BRCA1/2 mutation
- Have sufficient archival formalin-fixed paraffin-embedded (FFPE) tumor tissue available for planned analyses
Exclusion Criteria
- History of prior cancers except for those that have been curatively treated, with no evidence of cancer currently (provided all chemotherapy was completed >6 months prior and/or bone marrow transplant >2 years prior to first dose of rucaparib).
- Prior treatment with any PARP inhibitor
- Symptomatic and/or untreated central nervous system metastases
- Pre-existing duodenal stent and/or any other gastrointestinal disorder or defect that would, in the opinion of the Investigator, interfere with absorption of rucaparib
- Women who are pregnant or breast feeding
- Hospitalization for bowel obstruction within 3 months prior to enrollment
Data sourced from ClinicalTrials.gov (NCT02855944) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.