TriangleNCT02184195 · STUDY IN CONTEXT
Olaparib in gBRCA Mutated Pancreatic Cancer Whose Disease Has Not Progressed on First Line Platinum-Based Chemotherapy
Draft scope assessment: unclear. Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. 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
To determine the efficacy of olaparib maintenance monotherapy compared to placebo by PFS. The PFS was defined as the time from randomisation until the date of objective radiological disease progression according to modified RECIST v1.1 or death (by any cause in the absence of disease progression) regardless of whether the patient withdrew from randomized therapy or received another anticancer therapy prior to disease progression.
To determine the efficacy by assessment of OS of olaparib maintenance monotherapy compared to placebo. The OS was defined as the time from the date of randomization until death due to any cause.
To determine efficacy by assessment of PFS2 of olaparib maintenance monotherapy compared to placebo. The PFS2 was defined as the time from the date of randomisation to the earliest of the progression event subsequent to that used for the primary variable PFS or death.
To determine the efficacy by assessment of TSST of olaparib maintenance monotherapy compared to placebo. The TSST was defined as time to second subsequent therapy or death.
To determine the efficacy by assessment of TFST of olaparib maintenance monotherapy compared to placebo. The TFST was defined as time to first subsequent therapy or death.
To determine the efficacy by assessment of TDT compared to placebo. compared to placebo. The TDT was defined as time to study treatment discontinuation or death.
Reported safety
Quality of life and patient-reported measures
EORTC QLQ · Adjusted Mean Change From Baseline up to 6 Months in Global Quality of Life (QoL) Score From the EORTC-QLQ-C30 Questionnaire
Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-cancer-metastatic-aecf3979
- nct id
- NCT02184195
- qol key
- qol-0008
- source section id
- NCT02184195-om-0008
- source outcome index
- 8
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- Adjusted Mean Change From Baseline up to 6 Months in Global Quality of Life (QoL) Score From the EORTC-QLQ-C30 Questionnaire
- measure definition
- To assess the effect of olaparib on health-related quality of life (QoL) as measured by the EORTC-QLQ-C30 global QoL scale. The EORTC-QLQ-C30 is defined as EORTC QLQ-C30: a questionnaire (30 questions) used to evaluate disease symptoms, functional impacts (eg, physical functioning), and HRQoL and to characterize clinical benefit from the patient perspective. The HRQoL score ranges from 0 to 100. A higher score indicates better QoL. A score change of 10 points was pre-defined as clinically meaningful. bd twice daily.
- time frame
- From baseline up to 6 months
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- 1
- direction quote
- higher score indicates better
- population note
- Patient reported outcome (PRO) analysis set was defined as the analysis population for PRO data were a subset of the FAS (ITT) population who had evaluable baseline EORTC QLQ-C30 or QLQ-PAN26 forms where evaluable meant that at least 1 sub-scale baseline score could be determined from at least 1 of the 2 forms.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-cancer-metastatic-aecf3979
- nct id
- NCT02184195
- trial label
- Olaparib in gBRCA Mutated Pancreatic Cancer Whose Disease Has Not Progressed on First Line Platinum-Based Chemotherapy
- applicability
- unclear
- applicability note
- Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
- 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
- 1
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-cancer-metastatic-aecf3979
- nct id
- NCT02184195
- outcome key
- om-0000
- source section id
- NCT02184195-om-0000
- source outcome index
- 0
- endpoint
- Progression-free Survival (PFS) by Blinded Independent Central Review (BICR) Using Modified Response Evaluation Criteria in Solid Tumours. This Study Used Modified RECIST Version (v) 1.1 (RECIST v1.1)
- endpoint definition
- To determine the efficacy of olaparib maintenance monotherapy compared to placebo by PFS. The PFS was defined as the time from randomisation until the date of objective radiological disease progression according to modified RECIST v1.1 or death (by any cause in the absence of disease progression) regardless of whether the patient withdrew from randomized therapy or received another anticancer therapy prior to disease progression.
- time origin
- Up to 4 years
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Intention to treat (ITT): All randomised patients, Myriad confirmed Breast cancer susceptibility gene mutation (gBRCAm) subgroup.
- 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-pancreatic-cancer-metastatic-aecf3979
- nct id
- NCT02184195
- outcome key
- om-0001
- source section id
- NCT02184195-om-0001
- source outcome index
- 1
- endpoint
- Overall Survival (OS)
- endpoint definition
- To determine the efficacy by assessment of OS of olaparib maintenance monotherapy compared to placebo. The OS was defined as the time from the date of randomization until death due to any cause.
- time origin
- Upto 4 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Intention to treat (ITT): All randomised patients, Myriad confirmed Breast cancer susceptibility gene mutation (gBRCAm) subgroup.
- 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-pancreatic-cancer-metastatic-aecf3979
- nct id
- NCT02184195
- outcome key
- om-0002
- source section id
- NCT02184195-om-0002
- source outcome index
- 2
- endpoint
- Time From Randomisation to Second Progression (PFS2)
- endpoint definition
- To determine efficacy by assessment of PFS2 of olaparib maintenance monotherapy compared to placebo. The PFS2 was defined as the time from the date of randomisation to the earliest of the progression event subsequent to that used for the primary variable PFS or death.
- time origin
- Up to 4 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Intention to treat (ITT): All randomised patients, Myriad confirmed Breast cancer susceptibility gene mutation (gBRCAm) subgroup.
- 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-pancreatic-cancer-metastatic-aecf3979
- nct id
- NCT02184195
- outcome key
- om-0003
- source section id
- NCT02184195-om-0003
- source outcome index
- 3
- endpoint
- Time From Randomisation to Second Subsequent Therapy or Death (TSST)
- endpoint definition
- To determine the efficacy by assessment of TSST of olaparib maintenance monotherapy compared to placebo. The TSST was defined as time to second subsequent therapy or death.
- time origin
- Up to 4 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Intention to treat (ITT): All randomised patients, Myriad confirmed Breast cancer susceptibility gene mutation (gBRCAm) subgroup.
- 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-pancreatic-cancer-metastatic-aecf3979
- nct id
- NCT02184195
- outcome key
- om-0004
- source section id
- NCT02184195-om-0004
- source outcome index
- 4
- endpoint
- Time From Randomisation to First Subsequent Therapy or Death (TFST)
- endpoint definition
- To determine the efficacy by assessment of TFST of olaparib maintenance monotherapy compared to placebo. The TFST was defined as time to first subsequent therapy or death.
- time origin
- Up to 4 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Intention to treat (ITT): All randomised patients, Myriad confirmed Breast cancer susceptibility gene mutation (gBRCAm) subgroup.
- 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-pancreatic-cancer-metastatic-aecf3979
- nct id
- NCT02184195
- outcome key
- om-0005
- source section id
- NCT02184195-om-0005
- source outcome index
- 5
- endpoint
- Time From Randomisation to Study Treatment Discontinuation or Death (TDT)
- endpoint definition
- To determine the efficacy by assessment of TDT compared to placebo. compared to placebo. The TDT was defined as time to study treatment discontinuation or death.
- time origin
- Up to 4 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Intention to treat (ITT): All randomised patients, Myriad confirmed Breast cancer susceptibility gene mutation (gBRCAm) subgroup.
- 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-pancreatic-cancer-metastatic-aecf3979
- nct id
- NCT02184195
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Olaparib 300 mg Twice Daily (bd)
- regimen
- Randomised participants received orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.
- analyzed count
- 92
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02184195-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-cancer-metastatic-aecf3979
- nct id
- NCT02184195
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Placebo
- regimen
- Randomised participants received placebo tablets orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.
- analyzed count
- 62
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02184195-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-cancer-metastatic-aecf3979
- nct id
- NCT02184195
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Olaparib 300 mg Twice Daily (bd)
- regimen
- Randomised participants received orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.
- analyzed count
- 92
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02184195-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-cancer-metastatic-aecf3979
- nct id
- NCT02184195
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Placebo
- regimen
- Randomised participants received placebo tablets orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.
- analyzed count
- 62
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02184195-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-cancer-metastatic-aecf3979
- nct id
- NCT02184195
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Olaparib 300 mg Twice Daily (bd)
- regimen
- Randomised participants received orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.
- analyzed count
- 92
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02184195-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-cancer-metastatic-aecf3979
- nct id
- NCT02184195
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Placebo
- regimen
- Randomised participants received placebo tablets orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.
- analyzed count
- 62
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02184195-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-cancer-metastatic-aecf3979
- nct id
- NCT02184195
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Olaparib 300 mg Twice Daily (bd)
- regimen
- Randomised participants received orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.
- analyzed count
- 92
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02184195-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-cancer-metastatic-aecf3979
- nct id
- NCT02184195
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Placebo
- regimen
- Randomised participants received placebo tablets orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.
- analyzed count
- 62
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02184195-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-cancer-metastatic-aecf3979
- nct id
- NCT02184195
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Olaparib 300 mg Twice Daily (bd)
- regimen
- Randomised participants received orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.
- analyzed count
- 92
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02184195-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-cancer-metastatic-aecf3979
- nct id
- NCT02184195
- outcome key
- om-0004
- arm key
- OG001
- arm label
- Placebo
- regimen
- Randomised participants received placebo tablets orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.
- analyzed count
- 62
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02184195-om-0004#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-cancer-metastatic-aecf3979
- nct id
- NCT02184195
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Olaparib 300 mg Twice Daily (bd)
- regimen
- Randomised participants received orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.
- analyzed count
- 92
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02184195-om-0005#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-cancer-metastatic-aecf3979
- nct id
- NCT02184195
- outcome key
- om-0005
- arm key
- OG001
- arm label
- Placebo
- regimen
- Randomised participants received placebo tablets orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.
- analyzed count
- 62
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02184195-om-0005#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-cancer-metastatic-aecf3979
- nct id
- NCT02184195
- harm key
- EG000
- source section id
- NCT02184195-ae
- event group key
- EG000
- event group label
- Olaparib 300 mg Twice Daily (bd)
- serious affected
- 28
- serious at risk
- 90
- other affected
- 89
- other at risk
- 90
- frequency threshold
- 5
- collection period
- From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years).
- event definition
- Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
- 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-pancreatic-cancer-metastatic-aecf3979
- nct id
- NCT02184195
- harm key
- EG001
- source section id
- NCT02184195-ae
- event group key
- EG001
- event group label
- Placebo
- serious affected
- 10
- serious at risk
- 61
- other affected
- 56
- other at risk
- 61
- frequency threshold
- 5
- collection period
- From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years).
- event definition
- Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-cancer-metastatic-aecf3979
- nct id
- NCT02184195
- qol key
- qol-0008
- source section id
- NCT02184195-om-0008
- source outcome index
- 8
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- Adjusted Mean Change From Baseline up to 6 Months in Global Quality of Life (QoL) Score From the EORTC-QLQ-C30 Questionnaire
- measure definition
- To assess the effect of olaparib on health-related quality of life (QoL) as measured by the EORTC-QLQ-C30 global QoL scale. The EORTC-QLQ-C30 is defined as EORTC QLQ-C30: a questionnaire (30 questions) used to evaluate disease symptoms, functional impacts (eg, physical functioning), and HRQoL and to characterize clinical benefit from the patient perspective. The HRQoL score ranges from 0 to 100. A higher score indicates better QoL. A score change of 10 points was pre-defined as clinically meaningful. bd twice daily.
- time frame
- From baseline up to 6 months
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- 1
- direction quote
- higher score indicates better
- population note
- Patient reported outcome (PRO) analysis set was defined as the analysis population for PRO data were a subset of the FAS (ITT) population who had evaluable baseline EORTC QLQ-C30 or QLQ-PAN26 forms where evaluable meant that at least 1 sub-scale baseline score could be determined from at least 1 of the 2 forms.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- setting source links
Preserved source evidence · Not medical advice