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NCT02798536 · ClinicalTrials.gov registry record · Phase 1
Mesothelin-Targeted Immunotoxin LMB-100 in People With Malignant Mesothelioma
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
NCT02798536: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT02798536 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 21 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02798536, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
Study Summary
Background: LMB-100 is a man-made protein. It is attracted to the mesothelin protein. This is found in many tumors, including mesothelioma. But it is found in only a very small number of normal tissues. After binding to mesothelin on tumors, LMB-100 attacks and kills cancer cells. Researchers want to test LMB-100 in people with advanced mesothelioma. Objective: To find a safe dose and anti-tumor activity of LMB-100 for people with advanced mesothelioma. Eligibility: Adults ages 18 and older with: Advanced pleural or peritoneal mesothelioma that has not responded to platinum-based therapy Adequate organ function Design: Participants will be screened with: Samples of tumor tissue or tumor fluid. These can be new or from a previous procedure. Medical history Physical exam Blood, urine, and heart tests Chest x-rays Computed tomography (CT) or magnetic resonance imaging (MRI) scans Fluorodeoxyglucose (FDG)-positron emission tomography (PET) scans Participants will get LMB-100 on days 1, 3, and 5 of each 21-day cycle. It will be given through an intravenous (IV) catheter, a tube inserted in an arm vein. They will get standard medicines before each infusion to help prevent side effects. Each infusion lasts about 30 minutes. They will be monitored for up to 2 hours after. During each cycle, participants will repeat the screening tests. Participants will get the study drug for up to 4 cycles or until their disease worsens or they have intolerable side effects. About 4-6 weeks after their last infusion, participants will have a follow-up visit. They will repeat the study tests. Participants will have follow-up scans every 6 weeks until their disease gets worse. Participants will be called about once a year to see how they are doing.
Interventions
- DRUG nab-paclitaxel
- DRUG LMB-100
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2016-07-27 |
| Est. Completion | 2022-04-21 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02798536
The ClinicalTrials.gov registry entry for NCT02798536 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 21 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 nab-paclitaxel is the first listed.
NCT02798536 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02798536 about?
NCT02798536 is a clinical study titled "Mesothelin-Targeted Immunotoxin LMB-100 in People With Malignant Mesothelioma". Background: LMB-100 is a man-made protein. It is attracted to the mesothelin protein. This is found in many tumors, including mesothelioma. But it is found in only a very small number of normal tissues. After binding to mesothelin on tumors, LMB-100 attacks and kills cancer cells. Researchers want ...
What is the current status of trial NCT02798536?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2016-07-27. Estimated completion is 2022-04-21.
What interventions are being tested in trial NCT02798536?
The interventions under investigation include: nab-paclitaxel (DRUG), LMB-100 (DRUG).
Who is sponsoring clinical trial NCT02798536?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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