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NCT04222413 · ClinicalTrials.gov registry record · Phase 1
Metarrestin (ML-246) in Subjects With Metastatic Solid Tumors
A Phase 1 study of Advanced Solid Tumors and Colorectal Neoplasms, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 116
- Enrollment target
- 2
- Study locations
NCT04222413 is a Phase 1 study of Advanced Solid Tumors and Colorectal Neoplasms that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 116 participants, below the 198-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target (41% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT04222413, a Phase 1 study of Advanced Solid Tumors and Colorectal Neoplasms, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 116 participants
- Enrollment target
- 2
- Study locations
Study Summary
Background: Metastasis is the spread of cancer from one organ to a nonadjacent organ. It causes 90% of cancer deaths. No treatment specifically prevents or reduces metastasis. Researchers hope a new drug can help. It stops cancer cells from growing and spreading further and possibly shrink cancer lesions in distant organs. Objective: To find a safe dose of metarrestin and to see if this dose shrinks tumors. Eligibility: Adults age 18 and older with pancreatic cancer, breast cancer, or a solid tumor that has not been cured by standard therapies. Also, children age 12-17 with a solid tumor (other than a muscle tumor) with no standard therapy options. Design: Participants will be screened with: * blood tests * physical exam * documentation of disease confirmation or tumor biopsy * electrocardiogram to evaluate the heart * review of their medicines and their ability to do their normal activities Participants will take metarrestin by mouth until they cannot tolerate it or stop to benefit from it. They will keep a medicine diary. Participants will visit the Clinical Center. During the first month there are two brief hospital stays required with visits weekly or every other week thereafter. They will repeat some of the screening tests. They will fill out questionnaires. They will have tests of their cognitive function. They will have an electroencephalogram to record brain activity. They will have a computed tomography (CT) scan or magnetic resonance imaging (MRI). A CT is a series of X-rays of the body. An MRI uses magnets and radio waves to take pictures of the body. Adult participants may have tumor biopsies. Participants will have a follow-up visit 30 days after treatment ends. Then they will have follow-up phone calls or emails every 6 months for the rest of their life or until the study ends.
Conditions Studied
Interventions
- DRUG Metarrestin
Study Locations (2)
Kansas
- University of Kansas - Fairway
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 116 participants |
| Start Date | 2020-10-27 |
| Est. Completion | 2028-12-31 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04222413
The ClinicalTrials.gov registry entry for NCT04222413 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 116 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 198-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target (41% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 6 conditions, with Advanced Solid Tumors appearing as the primary indexed condition, and to 1 intervention - of which Metarrestin is the first listed.
NCT04222413 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Kansas, Maryland.
Frequently Asked Questions
What is clinical trial NCT04222413 about?
NCT04222413 is a clinical study titled "Metarrestin (ML-246) in Subjects With Metastatic Solid Tumors". Background: Metastasis is the spread of cancer from one organ to a nonadjacent organ. It causes 90% of cancer deaths. No treatment specifically prevents or reduces metastasis. Researchers hope a new drug can help. It stops cancer cells from growing and spreading further and possibly shrink cancer l...
What is the current status of trial NCT04222413?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 116 participants. The study started on 2020-10-27. Estimated completion is 2028-12-31.
What conditions does trial NCT04222413 study?
This clinical trial studies the following conditions: Advanced Solid Tumors, Colorectal Neoplasms, Metastatic Pancreatic Cancer, Advanced Breast Cancer, Pediatric Solid Tumor.
What interventions are being tested in trial NCT04222413?
The interventions under investigation include: Metarrestin (DRUG).
Who is sponsoring clinical trial NCT04222413?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04222413 being conducted?
This trial has 2 study locations across Kansas, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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