Trial · NCT03531840
Olaparib in People With Malignant Mesothelioma
NCT03531840, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2021-03-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Olaparib in People With Malignant Mesothelioma. Trials, record NCT03531840. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03531840
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Olaparib in People With Malignant Mesothelioma
- NCT number
- NCT03531840
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 23 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Mesothelioma
- Interventions
- Olaparib, ClinOmics
- First posted
- 2018-05-22
- Last updated
- 2021-04-09
- Results first posted
- 2021-03-11
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With an Objective Response | 6 months after enrollment of last patient | Number of participants overall who experienced partial or complete response. Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, and the Malignant Pleural Mesothelioma (MPM) criteria. Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. Complete Response is disappearance of all target lesions. |
| Primary | Number of Participants With Germline Deoxyribonucleic Acid (DNA) Repair Mutation Who Experienced Partial or Complete Response. | 6 months after enrollment of last patient | Number of participants with germline deoxyribonucleic acid (DNA) repair mutation who experienced partial or complete response. Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, and the Malignant Pleural Mesothelioma (MPM) criteria. Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. Complete Response is disappearance of all target lesions. |
| Primary | Percentage of Participants With Breast Cancer Type 1 Associated Protein-1 (BAP1) Somatic Mutations Who Experienced Partial or Complete Response. | 6 months after enrollment of last patient | Percentage of participants with germline deoxyribonucleic acid (DNA) repair mutation who experienced partial or complete response. Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, and the Malignant Pleural Mesothelioma (MPM) criteria. Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. Complete Response is disappearance of all target lesions. |
| Primary | Percentage of Subjects With Neither Germline Deoxyribonuclecic Acid (DNA) Repair Mutations Nor Somatic Breast Cancer Type 1 Associated Protein-1 (BAP1) Mutations Who Experienced Partial or Complete Response. | 6 months after enrollment of last patient | Percentage of subjects with neither germline DNA repair mutations nor somatic BAP1 mutations who experienced partial or complete response.Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, and the Malignant Pleural Mesothelioma (MPM) criteria. Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. Complete Response is disappearance of all target lesions. |
| Primary | Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0) | Adverse events were recorded from the study start date until prior to the study completion date, approximately 27 months and 11 days. | Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. |
| Secondary | Number of Participants With Dose Limiting-toxicities (DLT's) | 21 days after enrollment of last subject | Dose Limiting-toxicities (DLT's) is defined as |
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 | Number of Participants With an Objective Response | 6 months after enrollment of last patient | Data is grouped as specified per protocol. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Germline Deoxyribonucleic Acid (DNA) Repair Mutation Who Experienced Partial or Complete Response. | 6 months after enrollment of last patient | Per protocol, this outcome measure was only assessed in participants in Comparison Group 1. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Percentage of Participants With Breast Cancer Type 1 Associated Protein-1 (BAP1) Somatic Mutations Who Experienced Partial or Complete Response. | 6 months after enrollment of last patient | Per protocol, this outcome measure was only assessed in participants in Comparison Group 2. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Subjects With Neither Germline Deoxyribonuclecic Acid (DNA) Repair Mutations Nor Somatic Breast Cancer Type 1 Associated Protein-1 (BAP1) Mutations Who Experienced Partial or Complete Response. | 6 months after enrollment of last patient | Per protocol, this outcome measure was only assessed in participants in Comparison Group 3. | percentage of participants | NUMBER |
| PRIMARY | Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0) | Adverse events were recorded from the study start date until prior to the study completion date, approximately 27 months and 11 days. | Data is grouped as specified per protocol. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Dose Limiting-toxicities (DLT's) | 21 days after enrollment of last subject | Data is grouped as specified per protocol. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With an Objective Response | Comparison Group 1:Participants With a Germline Mutation in Deoxyribonucleic Acid (DNA) Repair Genes | Partial Response | 1 | Participants | |
| Number of Participants With an Objective Response | Comparison Group 2: Participants With BRCA1 Associated Protein-1 (BAP1) Somatic Mutations | Partial Response | 0 | Participants | |
| Number of Participants With an Objective Response | Comparison Group 3: Participants With Neither Germline Mutations Nor BAP 1 Somatic Mutations | Partial Response | 0 | Participants | |
| Number of Participants With an Objective Response | Participants Not Classified Under Comparison Groups | Partial Response | 0 | Participants | |
| Number of Participants With an Objective Response | Comparison Group 1:Participants With a Germline Mutation in Deoxyribonucleic Acid (DNA) Repair Genes | Complete Response | 0 | Participants | |
| Number of Participants With an Objective Response | Comparison Group 2: Participants With BRCA1 Associated Protein-1 (BAP1) Somatic Mutations | Complete Response | 0 | Participants | |
| Number of Participants With an Objective Response | Comparison Group 3: Participants With Neither Germline Mutations Nor BAP 1 Somatic Mutations | Complete Response | 0 | Participants | |
| Number of Participants With an Objective Response | Participants Not Classified Under Comparison Groups | Complete Response | 0 | Participants | |
| Number of Participants With Germline Deoxyribonucleic Acid (DNA) Repair Mutation Who Experienced Partial or Complete Response. | Comparison Group 1:Participants With a Germline Mutation in Deoxyribonucleic Acid (DNA) Repair Genes | Partial Response | 1 | Participants | |
| Number of Participants With Germline Deoxyribonucleic Acid (DNA) Repair Mutation Who Experienced Partial or Complete Response. | Comparison Group 1:Participants With a Germline Mutation in Deoxyribonucleic Acid (DNA) Repair Genes | Complete Response | 0 | Participants |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Comparison Group 1:Participants With a Germline Mutation in Deoxyribonucleic Acid (DNA) Repair Genes | 5 | |
| Overall Study | STARTED | Comparison Group 2: Participants With BRCA1 Associated Protein-1 (BAP1) Somatic Mutations | 6 | |
| Overall Study | STARTED | Comparison Group 3: Participants With Neither Germline Mutations Nor BAP 1 Somatic Mutations | 8 | |
| Overall Study | STARTED | Participants Not Classified Under Comparison Groups | 4 | |
| Overall Study | COMPLETED | Comparison Group 1:Participants With a Germline Mutation in Deoxyribonucleic Acid (DNA) Repair Genes | 0 | |
| Overall Study | COMPLETED | Comparison Group 2: Participants With BRCA1 Associated Protein-1 (BAP1) Somatic Mutations | 1 | |
| Overall Study | COMPLETED | Comparison Group 3: Participants With Neither Germline Mutations Nor BAP 1 Somatic Mutations | 3 | |
| Overall Study | COMPLETED | Participants Not Classified Under Comparison Groups | 1 | |
| Overall Study | NOT COMPLETED | Comparison Group 1:Participants With a Germline Mutation in Deoxyribonucleic Acid (DNA) Repair Genes | 5 | |
| Overall Study | NOT COMPLETED | Comparison Group 2: Participants With BRCA1 Associated Protein-1 (BAP1) Somatic Mutations | 5 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events460
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 | Comparison Group 1:Participants With a Germline Mutation in Deoxyribonucleic Acid (DNA) Repair Genes | 0 | 5 | 0 |
| other | Abdominal distension | Gastrointestinal disorders | Comparison Group 2: Participants With BRCA1 Associated Protein-1 (BAP1) Somatic Mutations | 1 | 6 | 1 |
| other | Abdominal distension | Gastrointestinal disorders | Comparison Group 3: Participants With Neither Germline Mutations Nor BAP 1 Somatic Mutations | 1 | 8 | 2 |
| other | Abdominal distension | Gastrointestinal disorders | Participants Not Classified Under Comparison Groups | 0 | 4 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Comparison Group 1:Participants With a Germline Mutation in Deoxyribonucleic Acid (DNA) Repair Genes | 2 | 5 | 2 |
| other | Abdominal pain | Gastrointestinal disorders | Comparison Group 2: Participants With BRCA1 Associated Protein-1 (BAP1) Somatic Mutations | 0 | 6 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Comparison Group 3: Participants With Neither Germline Mutations Nor BAP 1 Somatic Mutations | 2 | 8 | 4 |
| other | Abdominal pain | Gastrointestinal disorders | Participants Not Classified Under Comparison Groups | 2 | 4 | 2 |
| other | Activated partial thromboplastin time prolonged | Investigations | Comparison Group 1:Participants With a Germline Mutation in Deoxyribonucleic Acid (DNA) Repair Genes | 1 | 5 | 1 |
| other | Activated partial thromboplastin time prolonged | Investigations | Comparison Group 2: Participants With BRCA1 Associated Protein-1 (BAP1) Somatic Mutations | 2 | 6 | 2 |
1 to 10 of 460Source ClinicalTrials.gov
See all 460 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Comparison Group 1:Participants With a Germline Mutation in Deoxyribonucleic Acid (DNA) Repair Genes | 5 | 5 |
| Total, all-cause mortality | Comparison Group 2: Participants With BRCA1 Associated Protein-1 (BAP1) Somatic Mutations | 5 | 6 |
| Total, all-cause mortality | Comparison Group 3: Participants With Neither Germline Mutations Nor BAP 1 Somatic Mutations | 5 | 8 |
| Total, all-cause mortality | Participants Not Classified Under Comparison Groups | 3 | 4 |
| Total, other adverse events | Comparison Group 1:Participants With a Germline Mutation in Deoxyribonucleic Acid (DNA) Repair Genes | 5 | 5 |
| Total, other adverse events | Comparison Group 2: Participants With BRCA1 Associated Protein-1 (BAP1) Somatic Mutations | 6 | 6 |
| Total, other adverse events | Comparison Group 3: Participants With Neither Germline Mutations Nor BAP 1 Somatic Mutations | 8 | 8 |
| Total, other adverse events | Participants Not Classified Under Comparison Groups | 4 | 4 |
| Total, serious adverse events | Comparison Group 1:Participants With a Germline Mutation in Deoxyribonucleic Acid (DNA) Repair Genes | 1 | 5 |
| Total, serious adverse events | Comparison Group 2: Participants With BRCA1 Associated Protein-1 (BAP1) Somatic Mutations | 4 | 6 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT03531840
GET https://conductscience.org/api/trials/v1/NCT03531840/results?page=2