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NCT03531840 · ClinicalTrials.gov registry record · Phase 2
Olaparib in People With Malignant Mesothelioma
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 23
- Enrollment target
NCT03531840: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT03531840 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 23 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03531840, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 23 participants
- Enrollment target
Study Summary
Background: The drug olaparib may stop cancer cells from fixing damage to their deoxyribonucleic acid (DNA). It has been approved to treat certain cancers in people that were born with a mutation in the breast cancer (BRCA) gene. It has not been approved for treating mesothelioma. But some people with mesothelioma have mutations in a gene, BRCA1 Associated Protein 1 (BAP1) related to BRCA. Researchers want to see if olaparib can work in patients with mutations in this gene. They also want to see if works on mutations in other genes or patients without any mutations. They want to see if olaparib causes mesothelioma tumors to shrink. Objective: To study the effect of olaparib on mesothelioma. Eligibility: People ages 18 and older with malignant mesothelioma that has already been treated Design: Participants will be screened with Sample of tumor tissue or fluid Medical history Physical exam Blood, heart, and urine tests Scans and x-rays Participants will give blood and tissue samples. These will be genetically tested. The study will be done in 21-day cycles. Participants will take tables of the study drug 2 times each day. They will get information on what food and drugs to avoid during the study. They will get information about birth control. They will keep a diary of doses and symptoms. Participants will have blood and urine tests and scans every few weeks. Participants will be told any important genetic testing results. Participants will stay in the study until their disease gets worse or the participant or their doctor chooses to stop it. About 30 days after stopping the study drug, participants will have a follow-up visit. They will have a medical history, physical exam, blood tests, and scans. Some participants will continue to have scans every 6 weeks. ...
Primary Outcome
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.
Interventions
- DRUG Olaparib
- DEVICE ClinOmics
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2018-07-11 |
| Est. Completion | 2020-10-21 |
| Phase | Phase 2 |
What the finished NCT03531840 record still lists
NCT03531840 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 2 interventions - of which Olaparib is the first listed.
NCT03531840 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03531840 about?
NCT03531840 is a clinical study titled "Olaparib in People With Malignant Mesothelioma". Background: The drug olaparib may stop cancer cells from fixing damage to their deoxyribonucleic acid (DNA). It has been approved to treat certain cancers in people that were born with a mutation in the breast cancer (BRCA) gene. It has not been approved for treating mesothelioma. But some people w...
What is the current status of trial NCT03531840?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 23 participants. The study started on 2018-07-11. Estimated completion is 2020-10-21.
What interventions are being tested in trial NCT03531840?
The interventions under investigation include: Olaparib (DRUG), ClinOmics (DEVICE).
Who is sponsoring clinical trial NCT03531840?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03531840's enrollment target sits among peer trials
23 1784th of 2000 higher than 211 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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