Trial · NCT01891344
A Study of Rucaparib in Patients With Platinum-Sensitive, Relapsed, High-Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (ARIEL2)
NCT01891344, Phase 2, Completed, pharmaand GmbH; results first posted 2021-07-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Rucaparib in Patients With Platinum-Sensitive, Relapsed, High-Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (ARIEL2). Trials, record NCT01891344. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01891344
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Rucaparib in Patients With Platinum-Sensitive, Relapsed, High-Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (ARIEL2)
- NCT number
- NCT01891344
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 491 participants, actual
- Lead sponsor
- pharmaand GmbH
- Conditions
- Ovarian Cancer, Epithelial Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer
- Interventions
- Oral rucaparib
- First posted
- 2013-07-03
- Last updated
- 2023-06-12
- Other registries' IDs
- eudract:2013-000517-20
- Results first posted
- 2021-07-13
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival (PFS) According to RECIST v1.1 in Molecularly-defined HRD (Homologous Recombination Deficiency) Subgroups (Part 1 of Study) | 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. |
| Primary | Objective Response Rate (ORR) by RECIST v1.1 in Molecularly-defined HRD Subgroups (Part 2 of Study) | 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. |
| Secondary | Objective Response Rate (ORR) by RECIST v1.1 (Part 1 of Study) | 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. |
| Secondary | Objective Response Rate (ORR) by RECIST v1.1 and GCIG CA-125 Criteria | 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 from baseline: 1. in a sample collected after initiation of study treatment AND 2. that is confirmed in a subsequent sample collected ≥21 days after the prior sample. The absolute value of this confirmatory sample must be ≤110% of the prior sample. The date when the first sample with a 50% decrease from baseline is observed is the date of the CA-125 response. |
| Secondary | Duration of Response Per RECIST v1.1 | 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 a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter. |
| Secondary | Progression-free Survival (PFS) According to RECIST v1.1 in Molecularly-defined HRD Subgroups (Part 2 of Study) | 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. |
| Secondary | Overall Survival (Part 2 of Study) | 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. |
| Secondary | Steady State Trough (Cmin) Level Rucaparib Concentrations | 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. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival (PFS) According to RECIST v1.1 in Molecularly-defined HRD (Homologous Recombination Deficiency) Subgroups (Part 1 of Study) | 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. | Safety population by HRD subgroups: Consists of all Part 1 patients who received at least one dose of rucaparib. | Days | MEDIAN |
| PRIMARY | Objective Response Rate (ORR) by RECIST v1.1 in Molecularly-defined HRD Subgroups (Part 2 of Study) | 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. | Safety population by HRD subgroups: Consist of all Part 2 patients who received at least one dose of rucaparib. | percentage of participants | NUMBER |
| SECONDARY | Objective Response Rate (ORR) by RECIST v1.1 (Part 1 of Study) | 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. | Safety population by HRD subgroups: Consist of all Part 1 patients who received at least one dose of rucaparib | percentage of participants | NUMBER |
| SECONDARY | Objective Response Rate (ORR) by RECIST v1.1 and GCIG CA-125 Criteria | 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. | Safety population by HRD subgroups: Consist of all Part 1 and Part 2 patients who received at least one dose of rucaparib. | percentage of patients | NUMBER |
| SECONDARY | Duration of Response Per RECIST v1.1 | 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. | Efficacy population by HRD subgroups. The overall number of patients analyzed includes only patients with confirmed RECIST CR or PR. | Days | MEDIAN |
| SECONDARY | Progression-free Survival (PFS) According to RECIST v1.1 in Molecularly-defined HRD Subgroups (Part 2 of Study) | 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. | Safety population by HRD subgroups: Consist of all Part 2 patients who received at least one dose of rucaparib. | Days | MEDIAN |
| SECONDARY | Overall Survival (Part 2 of Study) | 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. | Safety population by HRD subgroups: Consist of all Part 2 patients who received at least one dose of rucaparib. | Months | MEDIAN |
| SECONDARY | Steady State Trough (Cmin) Level Rucaparib Concentrations | Cycle 1 Day 15 to Cycle 4 Day 1, or approximately 10 weeks | All Part 1 and Part 2 patients with at least one PK sample collected | ng/mL | MEAN |
Source ClinicalTrials.gov
Results by group44
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival (PFS) According to RECIST v1.1 in Molecularly-defined HRD (Homologous Recombination Deficiency) Subgroups (Part 1 of Study) | Part 1: tBRCA | 388 | 95% Confidence Interval 273 to 448 | Days | |
| Progression-free Survival (PFS) According to RECIST v1.1 in Molecularly-defined HRD (Homologous Recombination Deficiency) Subgroups (Part 1 of Study) | Part 1: Non-tBRCA LOH+ | 174 | 95% Confidence Interval 158 to 231 | Days | |
| Progression-free Survival (PFS) According to RECIST v1.1 in Molecularly-defined HRD (Homologous Recombination Deficiency) Subgroups (Part 1 of Study) | Part 1: Non-tBRCA LOH- | 160 | 95% Confidence Interval 110 to 188 | Days | |
| Progression-free Survival (PFS) According to RECIST v1.1 in Molecularly-defined HRD (Homologous Recombination Deficiency) Subgroups (Part 1 of Study) | Part 1: Non-tBRCA LOH Unknown | 223 | 95% Confidence Interval 55 to 499 | Days | |
| Objective Response Rate (ORR) by RECIST v1.1 in Molecularly-defined HRD Subgroups (Part 2 of Study) | Part 2: tBRCA | 31.0 | 95% Confidence Interval 21.3 to 42.0 | percentage of participants | |
| Objective Response Rate (ORR) by RECIST v1.1 in Molecularly-defined HRD Subgroups (Part 2 of Study) | Part 2: Non-tBRCA LOH+ | 6.8 | 95% Confidence Interval 2.3 to 15.3 | percentage of participants | |
| Objective Response Rate (ORR) by RECIST v1.1 in Molecularly-defined HRD Subgroups (Part 2 of Study) | Part 2: Non-tBRCA LOH- | 5.6 | 95% Confidence Interval 2.1 to 11.8 | percentage of participants | |
| Objective Response Rate (ORR) by RECIST v1.1 in Molecularly-defined HRD Subgroups (Part 2 of Study) | Part 2: Non-tBRCA LOH Unknown | 13.0 | 95% Confidence Interval 2.8 to 33.6 | percentage of participants | |
| Objective Response Rate (ORR) by RECIST v1.1 (Part 1 of Study) | Part 1: tBRCA | 80.0 | 95% Confidence Interval 64.4 to 90.9 | percentage of participants | |
| Objective Response Rate (ORR) by RECIST v1.1 (Part 1 of Study) | Part 1: Non-tBRCA LOH+ | 28.0 | 95% Confidence Interval 18.7 to 39.1 | percentage of participants |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Part 1: tBRCA | 40 | |
| Overall Study | STARTED | Part 1: Non-tBRCA LOH+ | 82 | |
| Overall Study | STARTED | Part 1: Non-tBRCA LOH- | 70 | |
| Overall Study | STARTED | Part 1: Non-tBRCA LOH Unknown | 12 | |
| Overall Study | STARTED | Part 2: tBRCA | 84 | |
| Overall Study | STARTED | Part 2: Non-tBRCA LOH+ | 73 | |
| Overall Study | STARTED | Part 2: Non-tBRCA LOH- | 107 | |
| Overall Study | STARTED | Part 2: Non-tBRCA LOH Unknown | 23 | |
| Overall Study | COMPLETED | Part 1: tBRCA | 34 | |
| Overall Study | COMPLETED | Part 1: Non-tBRCA LOH+ | 80 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events326
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 | Anaemia | Blood and lymphatic system disorders | Part 1 Overall | 72 | 204 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 2 Overall | 122 | 287 | |
| other | Neutropenia | Blood and lymphatic system disorders | Part 1 Overall | 12 | 204 | |
| other | Neutropenia | Blood and lymphatic system disorders | Part 2 Overall | 18 | 287 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Part 1 Overall | 23 | 204 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Part 2 Overall | 44 | 287 | |
| other | Abdominal distension | Gastrointestinal disorders | Part 1 Overall | 41 | 204 | |
| other | Abdominal distension | Gastrointestinal disorders | Part 2 Overall | 31 | 287 | |
| other | Abdominal pain | Gastrointestinal disorders | Part 1 Overall | 63 | 204 | |
| other | Abdominal pain | Gastrointestinal disorders | Part 2 Overall | 89 | 287 |
1 to 10 of 326Source ClinicalTrials.gov
See all 326 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part 1 Overall | 2 | 204 |
| Total, all-cause mortality | Part 2 Overall | 18 | 287 |
| Total, other adverse events | Part 1 Overall | 203 | 204 |
| Total, other adverse events | Part 2 Overall | 285 | 287 |
| Total, serious adverse events | Part 1 Overall | 54 | 204 |
| Total, serious adverse events | Part 2 Overall | 92 | 287 |
Source ClinicalTrials.gov
Papers5
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 |
|---|---|
| Part 1 Overall vs Part 2 Overall: deaths from any cause | Trial comparisons |
| Part 1 Overall vs Part 2 Overall: 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/NCT01891344
GET https://conductscience.org/api/trials/v1/NCT01891344/results?page=2