Trial · NCT01968213
Phase 3 Study of Rucaparib as Switch Maintenance After Platinum in Relapsed High Grade Serous or Endometrioid Ovarian Cancer (ARIEL3)
NCT01968213, Phase 3, Completed, pharmaand GmbH; results first posted 2018-08-03
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Phase 3 Study of Rucaparib as Switch Maintenance After Platinum in Relapsed High Grade Serous or Endometrioid Ovarian Cancer (ARIEL3). Trials, record NCT01968213. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01968213
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 3 Study of Rucaparib as Switch Maintenance After Platinum in Relapsed High Grade Serous or Endometrioid Ovarian Cancer (ARIEL3)
- NCT number
- NCT01968213
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 564 participants, actual
- Lead sponsor
- pharmaand GmbH
- Conditions
- Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer
- Interventions
- Rucaparib, Placebo
- First posted
- 2013-10-23
- Last updated
- 2023-06-09
- Other registries' IDs
- eudract:2013-000518-39
- Results first posted
- 2018-08-03
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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) | 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). |
| Secondary | Disease Progression According to RECIST v1.1, as Assessed by Independent Radiology Review (IRR), or Death From Any Cause (irrPFS) | 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). |
| Secondary | Overall Survival (OS) | 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. |
| Secondary | Time to a 4-point Decrease in the Disease-related Symptoms - Physical (DRS-P) Subscale of the FOSI-18 | 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 of improvement in disease-related physical symptoms on cancer therapy. |
| Secondary | Time to an 8-point Decrease in the Total Score of the FOSI-18 | 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 cancer therapy. |
| Secondary | Individual Model Parameter Estimates of Rucaparib and Covariates Identification | Study data collection occurred over approximately 7 months. | Concentration summary statistics |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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) | 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. | Intent-to-treat: All patients randomized | Months | MEDIAN |
| SECONDARY | Disease Progression According to RECIST v1.1, as Assessed by Independent Radiology Review (IRR), or Death From Any Cause (irrPFS) | 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. | Intent-to-treat: All patients randomized | months | MEDIAN |
| SECONDARY | Overall Survival (OS) | All patients were followed for survival up to approximately 8.2 years. | Intent-to-treat: All patients randomized | Months | MEDIAN |
| SECONDARY | Time to a 4-point Decrease in the Disease-related Symptoms - Physical (DRS-P) Subscale of the FOSI-18 | 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. | Intent-to-treat: All patients randomized | Months | MEDIAN |
| SECONDARY | Time to an 8-point Decrease in the Total Score of the FOSI-18 | 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. | Intent-to-treat: All patients randomized | Months | MEDIAN |
| SECONDARY | Individual Model Parameter Estimates of Rucaparib and Covariates Identification | Study data collection occurred over approximately 7 months. | All patients who are treated with rucaparib with at least one pharmacokinetic (PK) measurement | ng/mL | GEOMETRIC_MEAN |
Source ClinicalTrials.gov
Results by group13
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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) | Rucaparib 600 mg Tablets | 10.8 | 95% Confidence Interval 8.3 to 11.4 | Months | |
| 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) | Placebo Tablets | 5.4 | 95% Confidence Interval 5.3 to 5.5 | Months | |
| Disease Progression According to RECIST v1.1, as Assessed by Independent Radiology Review (IRR), or Death From Any Cause (irrPFS) | Rucaparib 600 mg Tablets | 13.7 | 95% Confidence Interval 11.0 to 19.1 | months | |
| Disease Progression According to RECIST v1.1, as Assessed by Independent Radiology Review (IRR), or Death From Any Cause (irrPFS) | Placebo Tablets | 5.4 | 95% Confidence Interval 5.1 to 5.5 | months | |
| Overall Survival (OS) | Rucaparib 600 mg Tablets | 36.0 | 95% Confidence Interval 32.8 to 39.4 | Months | |
| Overall Survival (OS) | Placebo Tablets | 43.2 | 95% Confidence Interval 38.1 to 46.9 | Months | |
| Time to a 4-point Decrease in the Disease-related Symptoms - Physical (DRS-P) Subscale of the FOSI-18 | Rucaparib 600 mg Tablets | 1.9 | 95% Confidence Interval 1.8 to 2.8 | Months | |
| Time to a 4-point Decrease in the Disease-related Symptoms - Physical (DRS-P) Subscale of the FOSI-18 | Placebo Tablets | 6.4 | 95% Confidence Interval 4.6 to 9.2 | Months | |
| Time to an 8-point Decrease in the Total Score of the FOSI-18 | Rucaparib 600 mg Tablets | 2.9 | 95% Confidence Interval 2.7 to 3.7 | Months | |
| Time to an 8-point Decrease in the Total Score of the FOSI-18 | Placebo Tablets | 10.8 | 95% Confidence Interval 9.2 to 17.5 | Months |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Rucaparib 600 mg Tablets | 375 | |
| Overall Study | STARTED | Placebo Tablets | 189 | |
| Overall Study | COMPLETED | Rucaparib 600 mg Tablets | 375 | |
| Overall Study | COMPLETED | Placebo Tablets | 189 | |
| Overall Study | NOT COMPLETED | Rucaparib 600 mg Tablets | 0 | |
| Overall Study | NOT COMPLETED | Placebo Tablets | 0 |
Source ClinicalTrials.gov
Adverse events328
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal distension | Gastrointestinal disorders | Rucaparib 600 mg Tablets | 49 | 372 | |
| other | Abdominal distension | Gastrointestinal disorders | Placebo Tablets | 22 | 189 | |
| other | Abdominal pain | Gastrointestinal disorders | Rucaparib 600 mg Tablets | 121 | 372 | |
| other | Abdominal pain | Gastrointestinal disorders | Placebo Tablets | 50 | 189 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Rucaparib 600 mg Tablets | 57 | 372 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Placebo Tablets | 11 | 189 | |
| other | Constipation | Gastrointestinal disorders | Rucaparib 600 mg Tablets | 143 | 372 | |
| other | Constipation | Gastrointestinal disorders | Placebo Tablets | 44 | 189 | |
| other | Diarrhoea | Gastrointestinal disorders | Rucaparib 600 mg Tablets | 130 | 372 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo Tablets | 43 | 189 |
1 to 10 of 328Source ClinicalTrials.gov
See all 328 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Rucaparib 600 mg Tablets | 9 | 372 |
| Total, all-cause mortality | Placebo Tablets | 2 | 189 |
| Total, other adverse events | Rucaparib 600 mg Tablets | 372 | 372 |
| Total, other adverse events | Placebo Tablets | 182 | 189 |
| Total, serious adverse events | Rucaparib 600 mg Tablets | 91 | 372 |
| Total, serious adverse events | Placebo Tablets | 20 | 189 |
Source ClinicalTrials.gov
Papers6
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Rucaparib 600 mg Tablets vs Placebo Tablets: deaths from any cause | Trial comparisons |
| Rucaparib 600 mg Tablets vs Placebo Tablets: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01968213
GET https://conductscience.org/api/trials/v1/NCT01968213/events?page=2