18 and older, female only, with Ovarian Cancer or Fallopian Tube 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.
Disease Progression According to RECIST Version 1.1, as Assessed by the Investigator, or Death From Any Cause (Investigator Progression Free Survival as Per invPFS)Primary· Every 12 calendar weeks (within 7 days prior is permitted) after start of treatment until treatment discontinuation due to disease progression. Total follow-up was up to approximately 3 years.
Progression-free survival by Investigator (invPFS) is defined as the time from randomization to disease progression, according to RECIST v1.1 criteria as assessed by the investigator, or death due to any cause, whichever occurs first. Progressive disease is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s).
Group
Value
95% CI
Rucaparib 600 mg Tablets
10.8
8.3 – 11.4
Placebo Tablets
5.4
5.3 – 5.5
Disease Progression According to RECIST v1.1, as Assessed by Independent Radiology Review (IRR), or Death From Any Cause (irrPFS)Secondary· Every 12 calendar weeks (within 7 days prior is permitted) after start of treatment until treatment discontinuation due to disease progression. Total follow-up was up to approximately 8.2 years.
To evaluate PFS by RECIST v1.1, as assessed by independent radiology review (IRR).
Group
Value
95% CI
Rucaparib 600 mg Tablets
13.7
11.0 – 19.1
Placebo Tablets
5.4
5.1 – 5.5
Overall Survival (OS)Secondary· All patients were followed for survival up to approximately 8.2 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 600 mg Tablets
36.0
32.8 – 39.4
Placebo Tablets
43.2
38.1 – 46.9
Time to a 4-point Decrease in the Disease-related Symptoms - Physical (DRS-P) Subscale of the FOSI-18Secondary· Screening, Day 1 of each treatment cycle, Treatment Discontinuation visit, and 28-day Follow-up visit. Total follow-up was up to approximately 6.4 years.
The National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy (NCCN-FACT) FACT-Ovarian Symptom Index (FOSI-18) is a questionnaire, for completion by patients, designed to assess the impact of cancer therapy on ovarian cancer-related symptoms and is based on numerical point scoring of symptoms. The DRS-P subscale of the questionnaire is specifically designed to assess physical symptoms of ovarian cancer and evaluate changes in the subscale point score in individual assessments over time. This study looked at the time to a 4-point reduction in subscale score as an indicator o
Group
Value
95% CI
Rucaparib 600 mg Tablets
1.9
1.8 – 2.8
Placebo Tablets
6.4
4.6 – 9.2
Time to an 8-point Decrease in the Total Score of the FOSI-18Secondary· Screening, Day 1 of each treatment cycle, Treatment Discontinuation visit, and 28-day Follow-up visit. Total follow-up was up to approximately 6.4 years.
The National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy (NCCN-FACT) FACT-Ovarian Symptom Index (FOSI-18) is a questionnaire, for completion by patients, designed to assess the impact of cancer therapy on ovarian cancer-related physical, emotional and treatment-related symptoms, and is based on numerical point scoring of symptoms. The questionnaire is designed to evaluate changes in the total score in individual assessments over time. This study looked at the time to an 8-point reduction in the total score as an indicator of improvement in disease-related symptoms on c
Group
Value
95% CI
Rucaparib 600 mg Tablets
2.9
2.7 – 3.7
Placebo Tablets
10.8
9.2 – 17.5
Individual Model Parameter Estimates of Rucaparib and Covariates IdentificationSecondary· Study data collection occurred over approximately 7 months.
Concentration summary statistics
Cycle 2 Day 1
Group
Value
95% CI
Rucaparib 600 mg Tablets
1128
± 95.42
Cycle 4 Day 1
Group
Value
95% CI
Rucaparib 600 mg Tablets
1136
± 86.19
Cycle 7 Day 1
Group
Value
95% CI
Rucaparib 600 mg Tablets
1165
± 78.53
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Rucaparib 600 mg Tablets
Serious: 91/372 (24%)
Deaths: 9/372
Placebo Tablets
Serious: 20/189 (11%)
Deaths: 2/189
Serious adverse events (104 terms)
Reaction
System
Rucaparib 600 mg Tablets
Placebo Tablets
Anaemia
Blood and lymphatic system disorders
—
—
Vomiting
Gastrointestinal disorders
—
—
Abdominal pain
Gastrointestinal disorders
—
—
Pyrexia
General disorders
—
—
Febrile neutropenia
Blood and lymphatic system disorders
—
—
Constipation
Gastrointestinal disorders
—
—
Myelodysplastic syndrome
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
Small intestinal obstruction
Gastrointestinal disorders
—
—
Acute kidney injury
Renal and urinary disorders
—
—
Gastrointestinal pain
Gastrointestinal disorders
—
—
Blood creatinine increased
Investigations
—
—
Dehydration
Metabolism and nutrition disorders
—
—
Osteoarthritis
Musculoskeletal and connective tissue disorders
—
—
Seizure
Nervous system disorders
—
—
Platelet count decreased
Investigations
—
—
Pancytopenia
Blood and lymphatic system disorders
—
—
Intestinal obstruction
Gastrointestinal disorders
—
—
General physical health deterioration
General disorders
—
—
Incarcerated hernia
General disorders
—
—
Sepsis
Infections and infestations
—
—
Urinary tract infection
Infections and infestations
—
—
Muscular weakness
Musculoskeletal and connective tissue disorders
—
—
Malignant melanoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Patients enrolled into this study will be stratified into 3 groups based on gene mutations identified in their tumor tissue. The purpose of this study is to evaluate patient response to maintenance treatment with rucaparib versus placebo. Response to treatment will be analyzed based on homologous recombination (HR) status of tumor samples.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT04676334 — CATCH-R: A Rollover Study to Provide Continued Access to Rucaparib
· Phase 3
· completed
NCT03462212 — Carboplatin-Paclitaxel-Bevacizumab vs Carbo-Pacli-Beva-Rucaparib vs Carbo-Pacli-Ruca, Selected According to HRD Status,
· Phase 1, PHASE2
· unknown
NCT04624178 — A Study of Rucaparib and Nivolumab in People With Leiomyosarcoma
· Phase 2
· active not recruiting
NCT04826198 — Safety and Efficacy of AsiDNATM, a DNA Repair Inhibitor, Administered Intravenously in Addition to PARP Inhibitors in Pa
· Phase 1, PHASE2
· terminated
NCT04539327 — Analysis of the Clinical Experience With Rucaparib in the Rucaparib Access Program (RAP) in Spain - A GEICO Study
· completed
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/NCT01968213.