Trial · NCT02184195
Olaparib in gBRCA Mutated Pancreatic Cancer Whose Disease Has Not Progressed on First Line Platinum-Based Chemotherapy
NCT02184195, Phase 3, Completed, AstraZeneca; results first posted 2020-01-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Olaparib in gBRCA Mutated Pancreatic Cancer Whose Disease Has Not Progressed on First Line Platinum-Based Chemotherapy. Trials, record NCT02184195. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02184195
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Olaparib in gBRCA Mutated Pancreatic Cancer Whose Disease Has Not Progressed on First Line Platinum-Based Chemotherapy
- NCT number
- NCT02184195
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 154 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Germline BRCA1/2 Mutations and, Metastatic Adenocarcinoma of the Pancreas
- Interventions
- Olaparib, Olaparib, Placebo, Placebo
- First posted
- 2014-07-09
- Last updated
- 2023-09-13
- Other registries' IDs
- eudract:2014-001589-85
- Results first posted
- 2020-01-27
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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) | Up to 4 years | 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. |
| Secondary | Overall Survival (OS) | Upto 4 years | 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. |
| Secondary | Time From Randomisation to Second Progression (PFS2) | Up to 4 years | 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. |
| Secondary | Time From Randomisation to Second Subsequent Therapy or Death (TSST) | Up to 4 years | 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. |
| Secondary | Time From Randomisation to First Subsequent Therapy or Death (TFST) | Up to 4 years | 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. |
| Secondary | Time From Randomisation to Study Treatment Discontinuation or Death (TDT) | Up to 4 years | 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. |
| Secondary | Number of Participants With Objective Response Rate (ORR) by BICR Using Modified RECIST 1.1 | Up to 4 years | To determine efficacy by assessment of objective response rate according to modified RECIST 1.1 of olaparib maintenance monotherapy compared to placebo. The ORR is defined as the number of with a BoR of CR and PR according to the BICR data divided by the number of patients in the treatment group with measurable disease at baseline. |
| Secondary | Disease Control Rate (DCR) by BICR Using Modified RECIST 1.1 | At 16 weeks | Efficacy by assessment of disease control rate according to modified RECIST 1.1 of olaparib maintenance monotherapy compared to placebo. |
| Secondary | Adjusted Mean Change From Baseline up to 6 Months in Global Quality of Life (QoL) Score From the EORTC-QLQ-C30 Questionnaire | From baseline up to 6 months | 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. |
| Secondary | Number of Participants With Adverse Events (AEs) | Up to 4 years | To assess the safety and tolerability of olaparib maintenance monotherapy. SAE: serious adverse events CTCAE: Common Terminology Criteria for Adverse Events |
Source ClinicalTrials.gov
Outcomes10
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) 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) | Up to 4 years | Intention to treat (ITT): All randomised patients, Myriad confirmed Breast cancer susceptibility gene mutation (gBRCAm) subgroup. | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) | Upto 4 years | Intention to treat (ITT): All randomised patients, Myriad confirmed Breast cancer susceptibility gene mutation (gBRCAm) subgroup. | Months | MEDIAN |
| SECONDARY | Time From Randomisation to Second Progression (PFS2) | Up to 4 years | Intention to treat (ITT): All randomised patients, Myriad confirmed Breast cancer susceptibility gene mutation (gBRCAm) subgroup. | Months | MEDIAN |
| SECONDARY | Time From Randomisation to Second Subsequent Therapy or Death (TSST) | Up to 4 years | Intention to treat (ITT): All randomised patients, Myriad confirmed Breast cancer susceptibility gene mutation (gBRCAm) subgroup. | Months | MEDIAN |
| SECONDARY | Time From Randomisation to First Subsequent Therapy or Death (TFST) | Up to 4 years | Intention to treat (ITT): All randomised patients, Myriad confirmed Breast cancer susceptibility gene mutation (gBRCAm) subgroup. | Months | MEDIAN |
| SECONDARY | Time From Randomisation to Study Treatment Discontinuation or Death (TDT) | Up to 4 years | Intention to treat (ITT): All randomised patients, Myriad confirmed Breast cancer susceptibility gene mutation (gBRCAm) subgroup. | Months | MEDIAN |
| SECONDARY | Number of Participants With Objective Response Rate (ORR) by BICR Using Modified RECIST 1.1 | Up to 4 years | All randomised patients with measurable disease at baseline. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Disease Control Rate (DCR) by BICR Using Modified RECIST 1.1 | At 16 weeks | Intention to treat (ITT): All randomised patients | Participants | NUMBER |
| SECONDARY | Adjusted Mean Change From Baseline up to 6 Months in Global Quality of Life (QoL) Score From the EORTC-QLQ-C30 Questionnaire | From baseline up to 6 months | 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. | Unit on scale | MEAN |
| SECONDARY | Number of Participants With Adverse Events (AEs) | Up to 4 years | Safety Analysis Set consisted of all patients who received at least one dose of study treatment. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group36
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) 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) | Olaparib 300 mg Twice Daily (bd) | 7.4 | 95% Confidence Interval 4.14 to 11.01 | Months | |
| 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) | Placebo | 3.8 | 95% Confidence Interval 3.52 to 4.86 | Months | |
| Overall Survival (OS) | Olaparib 300 mg Twice Daily (bd) | 19.0 | 95% Confidence Interval 15.28 to 26.32 | Months | |
| Overall Survival (OS) | Placebo | 19.2 | 95% Confidence Interval 14.32 to 26.12 | Months | |
| Time From Randomisation to Second Progression (PFS2) | Olaparib 300 mg Twice Daily (bd) | 16.9 | 95% Confidence Interval 8.21 to 23.85 | Months | |
| Time From Randomisation to Second Progression (PFS2) | Placebo | 9.3 | 95% Confidence Interval 8.15 to 13.54 | Months | |
| Time From Randomisation to Second Subsequent Therapy or Death (TSST) | Olaparib 300 mg Twice Daily (bd) | 14.9 | 95% Confidence Interval 9.13 to 19.78 | Months | |
| Time From Randomisation to Second Subsequent Therapy or Death (TSST) | Placebo | 9.6 | 95% Confidence Interval 8.34 to 12.98 | Months | |
| Time From Randomisation to First Subsequent Therapy or Death (TFST) | Olaparib 300 mg Twice Daily (bd) | 9.0 | 95% Confidence Interval 6.21 to 12.85 | Months | |
| Time From Randomisation to First Subsequent Therapy or Death (TFST) | Placebo | 5.4 | 95% Confidence Interval 3.94 to 6.21 | Months |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Olaparib 300 mg Twice Daily (bd) | 92 | |
| Overall Study | STARTED | Placebo | 62 | |
| Overall Study | COMPLETED | Olaparib 300 mg Twice Daily (bd) | 19 | |
| Overall Study | COMPLETED | Placebo | 7 | |
| Overall Study | NOT COMPLETED | Olaparib 300 mg Twice Daily (bd) | 73 | |
| Overall Study | NOT COMPLETED | Placebo | 55 |
Source ClinicalTrials.gov
Adverse events196
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 | Nausea | Gastrointestinal disorders | Olaparib 300 mg Twice Daily (bd) | 44 | 90 | 66 |
| other | Nausea | Gastrointestinal disorders | Placebo | 15 | 61 | 17 |
| other | Diarrhoea | Gastrointestinal disorders | Olaparib 300 mg Twice Daily (bd) | 34 | 90 | 49 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 10 | 61 | 11 |
| other | Abdominal pain | Gastrointestinal disorders | Olaparib 300 mg Twice Daily (bd) | 26 | 90 | 39 |
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 15 | 61 | 17 |
| other | Constipation | Gastrointestinal disorders | Olaparib 300 mg Twice Daily (bd) | 25 | 90 | 33 |
| other | Constipation | Gastrointestinal disorders | Placebo | 7 | 61 | 8 |
| other | Vomiting | Gastrointestinal disorders | Olaparib 300 mg Twice Daily (bd) | 23 | 90 | 49 |
| other | Vomiting | Gastrointestinal disorders | Placebo | 9 | 61 | 12 |
1 to 10 of 196Source ClinicalTrials.gov
See all 196 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Olaparib 300 mg Twice Daily (bd) | 68 | 92 |
| Total, all-cause mortality | Placebo | 52 | 62 |
| Total, other adverse events | Olaparib 300 mg Twice Daily (bd) | 89 | 90 |
| Total, other adverse events | Placebo | 56 | 61 |
| Total, serious adverse events | Olaparib 300 mg Twice Daily (bd) | 28 | 90 |
| Total, serious adverse events | Placebo | 10 | 61 |
Source ClinicalTrials.gov
Papers8
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Olaparib 300 mg Twice Daily (bd) vs Placebo: Number of Participants With Objective Response Rate (ORR) by BICR Using Modified RECIST 1.1 | Trial comparisons |
| Olaparib 300 mg Twice Daily (bd) vs Placebo: deaths from any cause | Trial comparisons |
| Olaparib 300 mg Twice Daily (bd) vs Placebo: 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/NCT02184195
GET https://conductscience.org/api/trials/v1/NCT02184195/results?page=2