Recruiting nowPhase 1
What this trial is trying to do
Metarrestin (ML-246) is an oral drug that researchers think may interfere with cancer cells’ ability to grow and spread to distant organs. This phase 1 trial is testing how much people with advanced solid tumours can safely take, and will also look for signs that tumours shrink.
The idea is to target metastasis—the spread of cancer—which causes much of the harm from advanced cancer, rather than relying only on treatments that act on the original tumour. The main measure is the maximum tolerated dose, while tumour shrinkage is a secondary sign of possible activity; there is no comparison treatment.
Worth knowing: This is a small, non-randomised early-phase trial, designed mainly to assess safety and dosing rather than to show that metarrestin helps people live longer or delays cancer growth.
Written from the trial's own registry entry to explain what the researchers are testing and why. Nothing here is a result — this trial has not reported one — and it is not a view on whether the treatment works or on whether it would suit you.
| Registry number | NCT04222413 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 1 |
| Design | not randomised, open label |
| Taking part | 116 people (planned) |
| Who can join | aged 12 Years to 120 Years |
| Run by | National Cancer Institute (NCI) |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug Metarrestin
What it is measuring
To identify the maximum tolerated dose (MTD) of metarrestin in subjects with metastatic solid tumors
This is the trial's main question — the one it is designed and sized to answer. Anything else it reports is a secondary finding, and secondary findings are far more likely to be chance.
Phase 1. Tests safety and dose in a small group. Some people do benefit, but that is not what the trial is designed to find out.
How the researchers describe it
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 activitiesParticipants 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.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
- Metastatic
Read automatically from the criteria below, to make the list searchable. It is a summary of what the text mentions, not a decision about whether you qualify — and where the two disagree, the criteria are right and this is wrong.
Who the trial is looking for
- INCLUSION CRITERIA:
- Adult (>= 18 years) subjects with:
- histologically or cytologically confirmed solid tumors (Phase IA).
OR
- -histologically or cytologically confirmed pancreatic, colorectal, or breast cancer (Phase IB)
OR
- 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,
- has site measurable per RECIST 1.1 (Phase IB only).
- progressed on or after at least one line of standard systemic chemotherapy (Phase IA and IB1)
- have no standard therapy option available (Phase IB2)
- Patients must have recovered from any acute toxicity related to prior therapy or surgery or disease to a grade 1 or less.
- Performance status
- Karnofsky >= 70% (for patients >= 16 years old), Lansky >= 70% (for patients <16 years old)
- Adequate hematological function defined by:
- absolute neutrophil count (ANC) >= 1.0 x 10(9)/L,
- transfusion-independent platelet count >= 100 x 10(9)/L,
- Hgb >= 9 g/ dL (patients who have received <= 2 PRBC transfusions within 48 hours are eligible)
- Adequate coa…
This is an extract. Whether you qualify is decided by the trial team against the full criteria, not by reading this page. Read the full eligibility criteria
Where it is running
Running at 2 sites. Listed in: United States.
Individual hospitals, and whether each is currently open, are listed on the registry record. Sites open and close throughout a trial.
Worth asking your oncology team
Being listed here is not a recommendation, and no one page can tell you whether a trial is right for you. These are the questions it raises.
- Is this trial open at a hospital I could realistically travel to?
- Given my stage, my previous treatment and my tumour's molecular profile, would I be eligible?
- What would I be giving up by joining — is the comparison arm the treatment I would otherwise be having?
- What is already known about the safety of what is being tested?
The source
Registry record NCT04222413, registered by National Cancer Institute (NCI) on ClinicalTrials.gov, a public database run by the US National Library of Medicine. The details on this page come from that record and are only ever as current as the sponsor has kept it.
This is a listing of a registered clinical trial, reproduced for information. It is not a recommendation, this site has no connection to the trial or its sponsor, and being listed here says nothing about whether the treatment works. Talk to your own oncology team before pursuing any trial.
This article summarises published research for general information. It is not medical advice, and it is not a substitute for a conversation with your own oncology team, who know your case. Do not start, stop, or change any treatment or supplement on the basis of what you read here.