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NCT02298946 · ClinicalTrials.gov registry record · Phase 1
AMP-224, a PD-1 Inhibitor, With Stereotactic Body Radiation Therapy in Metastatic Colorectal Cancer
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 17
- Enrollment target
NCT02298946: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT02298946 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 17 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02298946, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 17 participants
- Enrollment target
Study Summary
Background: \- T-cells are white blood cells that can find and kill germs and tumors. Cancer can keep T-cells from working. Researchers think a new drug called AMP-224 might help the T-cells in people with cancer. They think the drug might work even better when combined with a certain type of radiation therapy. Objective: \- To study the safety and effectiveness of AMP-224 together with 1 or 3 days of stereotactic body radiation therapy (SBRT) directed to the liver. Eligibility: \- People age 18 and older with metastatic colorectal cancer. Their cancer must have spread to the liver and not be responding to treatment. Design: * Participants will be screened with a medical history, physical exam, and blood and urine tests. Their tumors will be measured with computerized tomography (CT) scans or magnetic resonance imaging (MRI) of the chest, stomach, and pelvis. They will have an electrocardiogram (ECG) heart test. * Participants will have a small part of their tumor removed by needle (biopsy). * Participants will have 8 study visits over about 10 weeks. * At 1 visit, they will have another tumor biopsy. * At 1 visit, they will get a chemotherapy drug through a vein (intravenous (IV)). * At 6 visits, they will receive AMP-224 through an IV. * At 1 or 3 visits, they will have SBRT. Computed tomography (CT) scans will map the position of their tumor. Radiation beams of different intensities at different angles will be directed to the tumor. * At all visits, some screening procedures may be repeated. * After treatment ends, participants will have 7 follow-up visits over about 5 months. Blood will be drawn. Some screening procedures may be repeated.
Interventions
- DRUG Cyclophosphamide
- DRUG AMP-224
- RADIATION Stereotactic Body Radiation Therapy(SBRT)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2014-11-21 |
| Est. Completion | 2017-03-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02298946
The ClinicalTrials.gov registry entry for NCT02298946 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 17 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 3 interventions - of which Cyclophosphamide is the first listed.
NCT02298946 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02298946 about?
NCT02298946 is a clinical study titled "AMP-224, a PD-1 Inhibitor, With Stereotactic Body Radiation Therapy in Metastatic Colorectal Cancer". Background: \- T-cells are white blood cells that can find and kill germs and tumors. Cancer can keep T-cells from working. Researchers think a new drug called AMP-224 might help the T-cells in people with cancer. They think the drug might work even better when combined with a certain type of radia...
What is the current status of trial NCT02298946?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2014-11-21. Estimated completion is 2017-03-07.
What interventions are being tested in trial NCT02298946?
The interventions under investigation include: Cyclophosphamide (DRUG), AMP-224 (DRUG), Stereotactic Body Radiation Therapy(SBRT) (RADIATION).
Who is sponsoring clinical trial NCT02298946?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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