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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. 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. ...
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03531840
The ClinicalTrials.gov registry entry for NCT03531840 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Olaparib is the first listed.
NCT03531840 reports 0 study locations.
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.
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