TriangleNCT01891344 · STUDY IN CONTEXT
A Study of Rucaparib in Patients With Platinum-Sensitive, Relapsed, High-Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (ARIEL2)
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
Read the full study record and all posted results →
Linked outcomes
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.
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.
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.
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.
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.
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.
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-fallopian-tube-neoplasm
- nct id
- NCT01891344
- trial label
- A Study of Rucaparib in Patients With Platinum-Sensitive, Relapsed, High-Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (ARIEL2)
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- regulator-cited
- discovery note
- Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
- outcome Count
- 6
- harms Count
- 2
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-fallopian-tube-neoplasm
- nct id
- NCT01891344
- outcome key
- om-0000
- source section id
- NCT01891344-om-0000
- source outcome index
- 0
- endpoint
- Progression-free Survival (PFS) According to RECIST v1.1 in Molecularly-defined HRD (Homologous Recombination Deficiency) Subgroups (Part 1 of Study)
- endpoint definition
- 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.
- time origin
- 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.
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Safety population by HRD subgroups: Consists of all Part 1 patients who received at least one dose of rucaparib.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-fallopian-tube-neoplasm
- nct id
- NCT01891344
- outcome key
- om-0001
- source section id
- NCT01891344-om-0001
- source outcome index
- 1
- endpoint
- Objective Response Rate (ORR) by RECIST v1.1 in Molecularly-defined HRD Subgroups (Part 2 of Study)
- endpoint definition
- 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.
- time origin
- 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.
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Safety population by HRD subgroups: Consist of all Part 2 patients who received at least one dose of rucaparib.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-fallopian-tube-neoplasm
- nct id
- NCT01891344
- outcome key
- om-0002
- source section id
- NCT01891344-om-0002
- source outcome index
- 2
- endpoint
- Objective Response Rate (ORR) by RECIST v1.1 (Part 1 of Study)
- endpoint definition
- 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.
- time origin
- 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.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Safety population by HRD subgroups: Consist of all Part 1 patients who received at least one dose of rucaparib
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-fallopian-tube-neoplasm
- nct id
- NCT01891344
- outcome key
- om-0003
- source section id
- NCT01891344-om-0003
- source outcome index
- 3
- endpoint
- Objective Response Rate (ORR) by RECIST v1.1 and GCIG CA-125 Criteria
- endpoint definition
- 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.
- time origin
- 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.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Safety population by HRD subgroups: Consist of all Part 1 and Part 2 patients who received at least one dose of rucaparib.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-fallopian-tube-neoplasm
- nct id
- NCT01891344
- outcome key
- om-0004
- source section id
- NCT01891344-om-0004
- source outcome index
- 4
- endpoint
- Duration of Response Per RECIST v1.1
- endpoint definition
- 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.
- time origin
- 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.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Efficacy population by HRD subgroups. The overall number of patients analyzed includes only patients with confirmed RECIST CR or PR.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-fallopian-tube-neoplasm
- nct id
- NCT01891344
- outcome key
- om-0005
- source section id
- NCT01891344-om-0005
- source outcome index
- 5
- endpoint
- Progression-free Survival (PFS) According to RECIST v1.1 in Molecularly-defined HRD Subgroups (Part 2 of Study)
- endpoint definition
- 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.
- time origin
- 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.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Safety population by HRD subgroups: Consist of all Part 2 patients who received at least one dose of rucaparib.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-fallopian-tube-neoplasm
- nct id
- NCT01891344
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Part 1: tBRCA
- regimen
- Patients with a deleterious BRCA mutation detected in their tumor.
- analyzed count
- 40
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01891344-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-fallopian-tube-neoplasm
- nct id
- NCT01891344
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Part 1: Non-tBRCA LOH+
- regimen
- Patients without a BRCA mutation in their tumor, but have high LOH.
- analyzed count
- 82
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01891344-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-fallopian-tube-neoplasm
- nct id
- NCT01891344
- outcome key
- om-0000
- arm key
- OG002
- arm label
- Part 1: Non-tBRCA LOH-
- regimen
- Patients without a BRCA mutation in their tumor, but have low LOH.
- analyzed count
- 70
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01891344-om-0000#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-fallopian-tube-neoplasm
- nct id
- NCT01891344
- outcome key
- om-0000
- arm key
- OG003
- arm label
- Part 1: Non-tBRCA LOH Unknown
- regimen
- Patients without a BRCA mutation in their tumor, and have unknown LOH due to missing results and/or failed test result(s).
- analyzed count
- 12
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01891344-om-0000#groups/OG003
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-fallopian-tube-neoplasm
- nct id
- NCT01891344
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Part 2: tBRCA
- regimen
- Patients with a deleterious BRCA mutation detected in their tumor.
- analyzed count
- 84
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01891344-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-fallopian-tube-neoplasm
- nct id
- NCT01891344
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Part 2: Non-tBRCA LOH+
- regimen
- Patients without a BRCA mutation in their tumor, but have high LOH.
- analyzed count
- 73
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01891344-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-fallopian-tube-neoplasm
- nct id
- NCT01891344
- outcome key
- om-0001
- arm key
- OG002
- arm label
- Part 2: Non-tBRCA LOH-
- regimen
- Patients without a BRCA mutation in their tumor, but have low LOH.
- analyzed count
- 107
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01891344-om-0001#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-fallopian-tube-neoplasm
- nct id
- NCT01891344
- outcome key
- om-0001
- arm key
- OG003
- arm label
- Part 2: Non-tBRCA LOH Unknown
- regimen
- Patients without a BRCA mutation in their tumor, and have unknown LOH due to missing results and/or failed test result(s).
- analyzed count
- 23
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01891344-om-0001#groups/OG003
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-fallopian-tube-neoplasm
- nct id
- NCT01891344
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Part 1: tBRCA
- regimen
- Patients with a deleterious BRCA mutation detected in their tumor.
- analyzed count
- 40
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01891344-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-fallopian-tube-neoplasm
- nct id
- NCT01891344
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Part 1: Non-tBRCA LOH+
- regimen
- Patients without a BRCA mutation in their tumor, but have high LOH.
- analyzed count
- 82
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01891344-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-fallopian-tube-neoplasm
- nct id
- NCT01891344
- outcome key
- om-0002
- arm key
- OG002
- arm label
- Part 1: Non-tBRCA LOH-
- regimen
- Patients without a BRCA mutation in their tumor, but have low LOH.
- analyzed count
- 70
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01891344-om-0002#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-fallopian-tube-neoplasm
- nct id
- NCT01891344
- outcome key
- om-0002
- arm key
- OG003
- arm label
- Part 1: Non-tBRCA LOH Unknown
- regimen
- Patients without a BRCA mutation in their tumor, and have unknown LOH due to missing results and/or failed test result(s).
- analyzed count
- 12
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01891344-om-0002#groups/OG003
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-fallopian-tube-neoplasm
- nct id
- NCT01891344
- harm key
- EG000
- source section id
- NCT01891344-ae
- event group key
- EG000
- event group label
- Part 1 Overall
- serious affected
- 54
- serious at risk
- 204
- other affected
- 203
- other at risk
- 204
- frequency threshold
- 5
- collection period
- Adverse events were reported from the time informed consent was obtained until 28 days after last dose of study drug, approximately 5 years.
- event definition
- If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Adverse Events were monitored/assessed without regard to the subgroups.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-fallopian-tube-neoplasm
- nct id
- NCT01891344
- harm key
- EG001
- source section id
- NCT01891344-ae
- event group key
- EG001
- event group label
- Part 2 Overall
- serious affected
- 92
- serious at risk
- 287
- other affected
- 285
- other at risk
- 287
- frequency threshold
- 5
- collection period
- Adverse events were reported from the time informed consent was obtained until 28 days after last dose of study drug, approximately 5 years.
- event definition
- If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Adverse Events were monitored/assessed without regard to the subgroups.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice