Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01413451 · ClinicalTrials.gov registry record · Early Phase 1
Amatuximab for High Mesothelin Cancers
A Early Phase 1 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Early Phase 1
- Development phase
- 7
- Enrollment target
NCT01413451: Clinical Trial Early Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT01413451 is a Early Phase 1 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 7 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01413451, a Early Phase 1 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Early Phase 1
- Development phase
- 7 participants
- Enrollment target
Study Summary
Background: \- Amatuximab is a cancer treatment drug that targets mesothelin. High levels of this substance are found on some kinds of tumor cells. Lab studies have shown that amatuximab helps the immune system to kill cells that have high levels of mesothelin. However, more research is needed to determine how safe and effective amatuximab is for treating tumors with high levels of mesothelin. Objectives: \- To assess the safety and effectiveness of amatuximab in treating tumors with high levels of mesothelin. Eligibility: \- Individuals at least 18 years of age who have a type of cancer that overexpresses mesothelin. Design: * Participants will be screened with a medical history and physical exam. They will also have blood tests and tumor assessment studies. * Participants will have two intravenous doses of amatuximab several hours apart. Researchers will monitor them closely and do frequent blood draws. On the same day and also within 48 hours of the second dose, participants will have imaging studies. These studies will measure how well the amatuximab is working against the cancer. * Participants will have a third imaging study of the cancer about 1 week after the infusions. * Participants will have a followup visit 2 weeks after receiving amatuximab. This visit will require blood samples. Four weeks after receiving the drug, researchers will review patients symptoms or side effects. This interview can be done in person or by phone.
Interventions
- DRUG Amatuximab (MORab-009)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2011-07-12 |
| Est. Completion | 2013-11-15 |
| Phase | Early Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01413451
The ClinicalTrials.gov registry entry for NCT01413451 describes a study currently listed as terminated, categorized as Early Phase 1. The registered enrollment target is 7 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 1 intervention - of which Amatuximab (MORab-009) is the first listed.
NCT01413451 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01413451 about?
NCT01413451 is a clinical study titled "Amatuximab for High Mesothelin Cancers". Background: \- Amatuximab is a cancer treatment drug that targets mesothelin. High levels of this substance are found on some kinds of tumor cells. Lab studies have shown that amatuximab helps the immune system to kill cells that have high levels of mesothelin. However, more research is needed to d...
What is the current status of trial NCT01413451?
This trial is currently terminated. It is a Early Phase 1 study. The enrollment target is 7 participants. The study started on 2011-07-12. Estimated completion is 2013-11-15.
What interventions are being tested in trial NCT01413451?
The interventions under investigation include: Amatuximab (MORab-009) (DRUG).
Who is sponsoring clinical trial NCT01413451?
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
Explore more on PlainTrial
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.