Phase 2
Completed N=491
A Study of Rucaparib in Patients With Platinum-Sensitive, Relapsed, High-Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (ARIEL2)
Source: ClinicalTrials.gov NCT01891344 ↗Enrolled (actual)
491
Serious AEs
29.7%
Results posted
Jul 2021
Primary outcomePrimary: Progression-free Survival (PFS) According to RECIST v1.1 in Molecularly-defined HRD (Homologous Recombination Deficiency) Subgroups (Part 1 of Study) — 388; 174; 160; 223 Days
Summary
The purpose of this study is to determine which patients with ovarian, fallopian tube, and primary peritoneal cancer will best respond to treatment with rucaparib.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival (PFS) According to RECIST v1.1 in Molecularly-defined HRD (Homologous Recombination Deficiency) Subgroups (Part 1 of Study) |
388; 174; 160; 223 | — |
| PRIMARY Objective Response Rate (ORR) by RECIST v1.1 in Molecularly-defined HRD Subgroups (Part 2 of Study) |
31.0; 6.8; 5.6; 13.0 | — |
| SECONDARY Objective Response Rate (ORR) by RECIST v1.1 (Part 1 of Study) |
80.0; 28.0; 10.0; 33.3 | — |
| SECONDARY Objective Response Rate (ORR) by RECIST v1.1 and GCIG CA-125 Criteria |
87.5; 46.3; 21.4; 50.0; 54.8; 12.3 | — |
| SECONDARY Duration of Response Per RECIST v1.1 |
281; 329; 169; 225; 176; 282 | — |
| SECONDARY Progression-free Survival (PFS) According to RECIST v1.1 in Molecularly-defined HRD Subgroups (Part 2 of Study) |
223; 57; 113; 110 | — |
| SECONDARY Overall Survival (Part 2 of Study) |
22.7; 14.7; 13.3; 14.1 | — |
| SECONDARY Steady State Trough (Cmin) Level Rucaparib Concentrations |
2020.76; 2276.37; 1652.27; 1689.83; 1557.32; 1552.09 | — |
Eligibility Criteria
The following eligibility criteria pertain to patients enrolling into PART 2 of the study:
Inclusion:
- 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 at least 3 prior chemotherapy regimens. Non-chemotherapy regimens and maintenance therapies administered as single agent treatment will not count as a chemotherapy regimen
- Relapsed/progressive disease as confirmed by CT scan
- Have biopsiable and measurable disease. Note: biopsy is optional for patients known to harbor a deleterious gBRCA mutation
- Have sufficient archival formalin-fixed paraffin-embedded (FFPE) tumor tissue available for planned analyses
Exclusion:
- 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
- Hospitalization for bowel obstruction within 3 months prior to enrollment
Data sourced from ClinicalTrials.gov (NCT01891344). 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.