A Study of Rucaparib in Patients With Platinum-Sensitive, Relapsed, High-Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (ARIEL2)
CompletedPhase 2Results postedLast updated 12 June 2023
What this trial tests
Phase 2 trial testing Oral rucaparib in Ovarian Cancer in 491 participants. Completed in 28 September 2021.
18 and older, female only, with Ovarian Cancer or Epithelial Ovarian Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Progression-free Survival (PFS) According to RECIST v1.1 in Molecularly-defined HRD (Homologous Recombination Deficiency) Subgroups (Part 1 of Study)Primary· Assessments every 8 weeks from C1D1 until disease progression, death or withdrawal of consent. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3 years.
The primary efficacy endpoint of PFS is calculated as 1+ the number of days from the first dose of study drug to disease progression by RECIST (Response Evaluation Criteria in Solid Tumors), as determined by the investigator or death due to any cause, whichever occurs first. Progression is defined using RECIST v1.1, as at least a 20% increase in the sum of the longest diameter of target lesions, or a measureable increase in a non-target lesion, or the appearance of new lesions.
Group
Value
95% CI
Part 1: tBRCA
388
273 – 448
Part 1: Non-tBRCA LOH+
174
158 – 231
Part 1: Non-tBRCA LOH-
160
110 – 188
Part 1: Non-tBRCA LOH Unknown
223
55 – 499
Objective Response Rate (ORR) by RECIST v1.1 in Molecularly-defined HRD Subgroups (Part 2 of Study)Primary· Assessments every 8 weeks from C1D1 until disease progression, death or withdrawal of consent. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3 years.
The confirmed response rate by RECIST v1.1 is defined as the percentage of patients with a confirmed complete response (CR) or partial response (PR) on subsequent tumor assessment at least 28 days after first response documentation. Complete response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter.
Group
Value
95% CI
Part 2: tBRCA
31.0
21.3 – 42.0
Part 2: Non-tBRCA LOH+
6.8
2.3 – 15.3
Part 2: Non-tBRCA LOH-
5.6
2.1 – 11.8
Part 2: Non-tBRCA LOH Unknown
13.0
2.8 – 33.6
Objective Response Rate (ORR) by RECIST v1.1 (Part 1 of Study)Secondary· Assessments every 8 weeks from C1D1 until disease progression, death or withdrawal of consent. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3 years.
The confirmed response rate by RECIST v1.1 is defined as the percentage of patients with a confirmed CR or PR on subsequent tumor assessment at least 28 days after first response documentation. Complete response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter.
Group
Value
95% CI
Part 1: tBRCA
80.0
64.4 – 90.9
Part 1: Non-tBRCA LOH+
28.0
18.7 – 39.1
Part 1: Non-tBRCA LOH-
10.0
4.1 – 19.5
Part 1: Non-tBRCA LOH Unknown
33.3
9.9 – 65.1
Objective Response Rate (ORR) by RECIST v1.1 and GCIG CA-125 CriteriaSecondary· Assessments every 8 weeks from C1D1 until disease progression, death or withdrawal of consent. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3 years.
The endpoint of ORR defined as the percentage of patients with a best response of CR or PR using RECIST v 1.1 or a response per Gynecologic Cancer InterGroup cancer antigen 125 (GCIG CA-125) criteria. Complete response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter. A response to CA-125 has occurred if there is at least a 50% decrease
Group
Value
95% CI
Part 1: tBRCA
87.5
73.2 – 95.8
Part 1: Non-tBRCA LOH+
46.3
35.3 – 57.7
Part 1: Non-tBRCA LOH-
21.4
12.5 – 32.9
Part 1: Non-tBRCA LOH Unknown
50.0
21.1 – 78.9
Part 2: tBRCA
54.8
43.5 – 65.7
Part 2: Non-tBRCA LOH+
12.3
5.8 – 22.1
Part 2: Non-tBRCA LOH-
13.1
7.3 – 21.0
Part 2: Non-tBRCA LOH Unknown
30.4
13.2 – 52.9
Duration of Response Per RECIST v1.1Secondary· Assessments every 8 weeks from C1D1 until disease progression, death or withdrawal of consent. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3 years.
Duration of response (DOR) for any confirmed RECIST CR or PR measured from the date of the first occurrence of a response until the first occurrence of progressive disease (PD) per RECIST. For patients who continued treatment post-progression, the first date of progression was used for the analysis. Any patients with an ongoing response were censored at the date of the last post-baseline scan. Complete response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial response (PR) is at least
Group
Value
95% CI
Part 1: tBRCA
281
194 – 393
Part 1: Non-tBRCA LOH+
329
174 – 451
Part 1: Non-tBRCA LOH-
169
141 – 260
Part 1: Non-tBRCA LOH Unknown
225
100 – 1454
Part 2: tBRCA
176
169 – 312
Part 2: Non-tBRCA LOH+
282
111 – NA
Part 2: Non-tBRCA LOH-
314
169 – NA
Part 2: Non-tBRCA LOH Unknown
181
169 – 224
Progression-free Survival (PFS) According to RECIST v1.1 in Molecularly-defined HRD Subgroups (Part 2 of Study)Secondary· Assessments every 8 weeks from C1D1 until disease progression, death or withdrawal of consent. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3 years.
Progression-Free Survival (PFS) is calculated as 1+ the number of days from the first dose of study drug to disease progression by RECIST, as determined by the investigator or death due to any cause, whichever occurs first. Progression is defined using RECIST v1.1, as at least a 20% increase in the sum of the longest diameter of target lesions, or a measureable increase in a non-target lesion, or the appearance of new lesions.
Group
Value
95% CI
Part 2: tBRCA
223
188 – 275
Part 2: Non-tBRCA LOH+
57
54 – 112
Part 2: Non-tBRCA LOH-
113
63 – 165
Part 2: Non-tBRCA LOH Unknown
110
56 – 154
Overall Survival (Part 2 of Study)Secondary· All patients in Part 2 were followed for survival, subsequent therapy, and secondary malignancy every 12 weeks until death, loss to follow-up, withdrawal of consent from study or study closure, whichever happened first, up to 7 years.
Overall survival (OS) is defined as the number of days from the date of first dose of study drug to the date of death (due to any cause). Patients without a known date of death will be censored on the date the patient was last known to be alive.
Group
Value
95% CI
Part 2: tBRCA
22.7
16.7 – 28.6
Part 2: Non-tBRCA LOH+
14.7
10.8 – 19.8
Part 2: Non-tBRCA LOH-
13.3
9.1 – 16.0
Part 2: Non-tBRCA LOH Unknown
14.1
7.4 – 20.1
Steady State Trough (Cmin) Level Rucaparib ConcentrationsSecondary· Cycle 1 Day 15 to Cycle 4 Day 1, or approximately 10 weeks
Per protocol, the secondary PK endpoint, trough (Cmin) concentrations of rucaparib were summarized with descriptive statistics overall and by cycle in all patients with at least one PK sample collected. Blood samples for trough level PK analysis of rucaparib were drawn at the following timepoints only: on Day 15 of Cycle 1 and on Day 1 of Cycles 2, 3, and 4. Data for other timepoints is not available.
Cycle 1 Day 15
Group
Value
95% CI
Part 1 Overall
2020.76
± 1145.164
Part 2 Overall
2276.37
± 1587.586
Cycle 2 Day 1
Group
Value
95% CI
Part 1 Overall
1652.27
± 935.503
Part 2 Overall
1689.83
± 1039.953
Cycle 3 Day 1
Group
Value
95% CI
Part 1 Overall
1557.32
± 952.903
Part 2 Overall
1552.09
± 1054.346
Cycle 4 Day 1
Group
Value
95% CI
Part 1 Overall
1530.41
± 765.940
Part 2 Overall
1629.14
± 1026.999
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were reported from the time informed consent was obtained until 28 days after last dose of study drug, approximately 5 years..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Part 1 Overall
Serious: 54/204 (26%)
Deaths: 2/204
Part 2 Overall
Serious: 92/287 (32%)
Deaths: 18/287
Serious adverse events (101 terms)
Reaction
System
Part 1 Overall
Part 2 Overall
Anaemia
Blood and lymphatic system disorders
—
—
Small intestinal obstruction
Gastrointestinal disorders
—
—
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06412120 — Study Evaluating Safety, Tolerability, and Metabolism of Niraparib
· Phase 4
· recruiting
NCT06930755 — Study of NMS-03305293 in Adult Patients With Relapsed Ovarian Cancer
· Phase 1
· recruiting
NCT07318558 — A Clinical Trial of Sac-TMT in People With Non-HRD Positive Advanced Ovarian Cancer (MK-2870-021)
· Phase 3
· recruiting
NCT07491081 — EARLY Study: Evaluating the Specificity and Feasibility of the EARLY Biomarker Panel for Ovarian Cancer Detection
· NA
· recruiting
NCT07410676 — EBNK-001 Allogeneic NK Cells With Low-Dose IL-15 ± Pembrolizumab in Advanced Solid Tumors
· Phase 1, PHASE2
· recruiting
Other pharmaand GmbH trials
Trials by the same sponsor.
NCT04676334 — CATCH-R: A Rollover Study to Provide Continued Access to Rucaparib
· Phase 3
· completed
NCT04171700 — A Study to Evaluate Rucaparib in Participants With Solid Tumors and With Deleterious Mutations in HRR Genes
· Phase 2
· terminated
NCT04179396 — Study of Oral Rucaparib With Other Anticancer Agents in Metastatic Castration Resistant Prostate Cancer Patients (RAMP)
· Phase 1
· completed
NCT04150289 — A Disease Registry Encompassing the Care Of Patients With Multiple Myeloma on Panobinostat
· completed
NCT03824704 — A Study to Evaluate Rucaparib in Combination With Nivolumab in Patients With Selected Solid Tumors (ARIES)
· Phase 2
· terminated
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by pharmaand GmbH
Last refreshed: 12 June 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01891344.