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.
Investigator Assessed Progression-Free Survival (invPFS) by RECIST Version 1.1 for Rucaparib Versus Chemotherapy (Efficacy Population)Primary· Assessments every 8 weeks from Cycle 1 Day 1 (C1D1) until disease progression, death, or initiation of subsequent treatment. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3.5 years.
The primary efficacy endpoint is invPFS for the Treatment Part of the study. The time to invPFS is calculated in months as the time from randomization to disease progression +1 day, as determined by RECIST v1.1 (Response Evaluation Criteria in Solid Tumors) criteria 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 measurable increase in a non-target lesion, or the appearance of new lesions.
Group
Value
95% CI
Rucaparib
7.4
7.3 – 9.1
Chemotherapy
5.7
5.5 – 7.3
Investigator Assessed Progression-Free Survival (invPFS) by RECIST Version 1.1 for Rucaparib Versus Chemotherapy (ITT Population)Primary· Assessments every 8 weeks from C1D1 until disease progression, death, or initiation of subsequent treatment. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3.5 years.
The primary efficacy endpoint is invPFS for the Treatment Part of the study. The time to invPFS is calculated in months as the time from randomization to disease progression +1 day, as determined by RECIST v1.1 (Response Evaluation Criteria in Solid Tumors) criteria 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 measurable increase in a non-target lesion, or the appearance of new lesions.
Group
Value
95% CI
Rucaparib
7.4
6.7 – 7.9
Chemotherapy
5.7
5.5 – 6.7
Investigator Assessed Overall Response Rate (ORR) by RECIST v1.1 (Efficacy Population)Secondary· Assessments every 8 weeks from C1D1 until disease progression, death, or initiation of subsequent treatment. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3.5 years.
A secondary endpoint is the ORR for the Treatment Part of the study. ORR is defined as the percentage of patients with a confirmed CR (complete response) or PR (partial response) by RECIST v1.1. The confirmed response is defined as a CR or PR on subsequent tumor assessment at least 28 days after first response documentation. 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. PR is at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of
Group
Value
95% CI
Rucaparib
40.3
33.6 – 47.2
Chemotherapy
32.3
23.1 – 42.6
Investigator Assessed Overall Response Rate (ORR) by RECIST v1.1 (ITT Population)Secondary· Assessments every 8 weeks from C1D1 until disease progression, death, or initiation of subsequent treatment. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3.5 years.
A secondary endpoint is the ORR for the Treatment Part of the study. ORR is defined as the percentage of patients with a confirmed CR (complete response) or PR (partial response) by RECIST v1.1. The confirmed response is defined as a CR or PR on subsequent tumor assessment at least 28 days after first response documentation. 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. PR is at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of
Group
Value
95% CI
Rucaparib
37.9
31.6 – 44.7
Chemotherapy
30.2
21.7 – 39.9
Investigator Assessed Duration of Response (DOR) by RECIST v1.1 (Efficacy Population)Secondary· Assessments every 8 weeks from C1D1 until disease progression, death, or initiation of subsequent treatment. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3.5 years.
A secondary endpoint is the DOR for the Treatment Part of the study. The DOR as assessed by investigator is analyzed in the subgroup of patients who had a confirmed response by RECIST v1.1. DOR for any confirmed RECIST CR or PR will be measured from the date of the first response until the first date that progressive disease (PD) is documented. DOR is calculated in months as the time from the first date of the scan showing a response to the first scan with disease progression +1 day. Any patients with an ongoing response are censored at the date of the last post-baseline scan. Only tumor scans
Group
Value
95% CI
Rucaparib
9.4
7.5 – 11.1
Chemotherapy
7.2
4.0 – 11.4
Investigator Assessed Duration of Response (DOR) by RECIST v1.1 (ITT Population)Secondary· Assessments every 8 weeks from C1D1 until disease progression, death, or initiation of subsequent treatment. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3.5 years.
A secondary endpoint is the DOR for the Treatment Part of the study. The DOR as assessed by investigator is analyzed in the subgroup of patients who had a confirmed response by RECIST v1.1. DOR for any confirmed RECIST CR or PR will be measured from the date of the first response until the first date that progressive disease (PD) is documented. DOR is calculated in months as the time from the first date of the scan showing a response to the first scan with disease progression +1 day. Any patients with an ongoing response are censored at the date of the last post-baseline scan. Only tumor scans
Group
Value
95% CI
Rucaparib
9.4
7.5 – 11.1
Chemotherapy
7.2
3.9 – 9.4
Investigator Assessed Overall Response Rate (ORR) by RECIST v1.1 and/or CA-125 Response (Efficacy Population)Secondary· Assessments every 8 weeks from C1D1 until disease progression, death, or initiation of subsequent treatment. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3.5 years.
A secondary endpoint is ORR for the Treatment Part of the study defined as the percentage of patients with best response of CR or PR using RECIST v1.1 or 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. Response to CA-125 has occurre
Group
Value
95% CI
Rucaparib
50.7
43.8 – 57.5
Chemotherapy
43.6
33.7 – 53.8
Investigator Assessed Overall Response Rate (ORR) by RECIST v1.1 and/or CA-125 Response (ITT Population)Secondary· Assessments every 8 weeks from C1D1 until disease progression, death, or initiation of subsequent treatment. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3.5 years.
A secondary endpoint is ORR for the Treatment Part of the study defined as the percentage of patients with best response of CR or PR using RECIST v1.1 or 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. Response to CA-125 has occurre
Group
Value
95% CI
Rucaparib
47.8
41.2 – 54.5
Chemotherapy
40.5
31.3 – 50.3
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)Secondary· Baseline to the end of Cycle 6, or up to approximately 6 months
EORTC QLQ-C30 is a questionnaire that rates the overall quality of life in cancer patients. The first 28 questions use a 4-point scale (1=not at all to 4=very much) for evaluating function (physical, role, social, cognitive, emotional), symptoms (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea/vomiting, constipation, and pain) and financial difficulties. The last 2 questions use a 7-point scale (1=very poor to 7=excellent) to evaluate overall health and quality of life. Global scores are converted to a score of 0 to 100, with a higher score indicating improved health status. Mean c
Group
Value
95% CI
Rucaparib
0.5
± 0.55
Chemotherapy
0.3
± 0.86
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)Secondary· Baseline to the end of Cycle 6, or up to approximately 6 months
EORTC QLQ-C30 is a questionnaire that rates the overall quality of life in cancer patients. The first 28 questions use a 4-point scale (1=not at all to 4=very much) for evaluating function (physical, role, social, cognitive, emotional), symptoms (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea/vomiting, constipation, and pain) and financial difficulties. The last 2 questions use a 7-point scale (1=very poor to 7=excellent) to evaluate overall health and quality of life. Global scores are converted to a score of 0 to 100, with a higher score indicating improved health status. Mean c
Group
Value
95% CI
Rucaparib
0.6
± 0.54
Chemotherapy
0.4
± 0.82
Overall Survival (Efficacy Population)Secondary· All patients were followed for survival up to approximately 3.5 years.
Overall survival (OS) is defined as the number of days from the date of randomization to the date of death (due to any cause). Patients who are still alive were censored on the date of their last available visit or last date known to be alive.
Group
Value
95% CI
Rucaparib
21.1
17.9 – 24.9
Chemotherapy
26.2
22.2 – 29.1
Overall Survival (ITT Population)Secondary· All patients were followed for survival up to approximately 3.5 years.
Overall survival (OS) is defined as the number of days from the date of randomization to the date of death (due to any cause). Patients who are still alive were censored on the date of their last available visit or last date known to be alive.
Group
Value
95% CI
Rucaparib
19.4
15.2 – 23.6
Chemotherapy
25.4
21.4 – 27.6
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 3.5 years..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Rucaparib (Treatment Part)
Serious: 66/232 (28%)
Deaths: 16/232
Chemotherapy (Treatment Part)
Serious: 14/113 (12%)
Deaths: 4/113
Rucaparib (Crossover Part)
Serious: 24/80 (30%)
Deaths: 3/80
Serious adverse events (85 terms)
Reaction
System
Rucaparib (Treatment Part)
Chemotherapy (Treatment Pa…
Rucaparib (Crossover Part)
Anemia
Blood and lymphatic system disorders
—
—
—
Intestinal obstruction
Gastrointestinal disorders
—
—
—
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
—
Thrombocytopenia
Blood and lymphatic system disorders
—
—
—
Neutropenia
Blood and lymphatic system disorders
—
—
—
Vomiting
Gastrointestinal disorders
—
—
—
Pneumonia
Infections and infestations
—
—
—
Myelodysplastic syndrome
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07391774 — Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribocic
· Phase 3
· not yet recruiting
NCT07476287 — Symbiotic-Lung-14: A Study to Learn About the Study Medicine Called PF08634404 in Combination With Chemotherapy in Adult
· Phase 2
· recruiting
NCT07392892 — A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Gastroesophageal Cancer
· Phase 2, PHASE3
· recruiting
NCT07288034 — Immunotherapy Biomarkers to Predict First-line PD(L)1-based Immunotherapy Response and Selection of Second-line Treatmen
· Phase 2
· recruiting
NCT07078604 — A Cancer Vaccine (STEMVAC) in Combination With Chemotherapy for the Treatment of PD-L1 Negative Metastatic Triple-Negati
· Phase 2
· recruiting
Other recruiting trials for Ovarian Cancer
Currently open trials in the same condition.
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: 9 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/NCT02855944.