Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
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RecruitingPhase 1interventionalRules rewrite

Phase 1: testing Metarrestin for Advanced Solid Tumors

Background: Metastasis is the spread of cancer from one organ to a nonadjacent organ. No treatment specifically prevents or reduces metastasis.

Official registry: https://clinicaltrials.gov/study/NCT04222413 · National Cancer Institute (NCI) · enrollment listed as 116

What this phase means

Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Metarrestin. The registry lists allocation as randomized. Background: Metastasis is the spread of cancer from one organ to a nonadjacent organ.

They plan to enroll about 116 people at 2 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

First-in-Human Phase I Trial to Investigate the Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of Metarrestin (ML-246) in Subjects With Metastatic Solid Tumors

Interventions: Metarrestin

Primary outcome (registry wording): To identify the maximum tolerated dose (MTD) of metarrestin in subjects with metastatic solid tumors

Who it is for (from inclusion criteria)

  • Ages 12 Years to 120 Years
  • Adult (\>= 18 years) subjects with:
  • histologically or cytologically confirmed solid tumors (Phase IA)
  • histologically or cytologically confirmed pancreatic, colorectal, or breast cancer (Phase IB)
  • Pediatric (\>=12 and \< 18 years) subjects with histologically or cytologically confirmed solid tumors other than rhabdomyosarcoma (RMS) including embryonal, alveolar, spindle cell/sclerosing, and pleomorphic subtypes of RMS (Phase IB)
  • Subjects must have disease that:
  • is not amenable to potentially curative resection,
  • spread at least to one other organ system other than primary tumor or recurred after removal of primary tumor,

Public study contact (from the registry)

Murielle Hogu

(240) 858-3335

murielle.hogu@nih.gov

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

2 listed

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FAQ about this NCT record

Is NCT04222413 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT04222413?

Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT04222413?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary