Metarrestin (ML-246) in Subjects With Metastatic Solid Tumors

Last Update Posted : 2023-02-03

The aim of the trial

The aim of this trial is to test the safety and response to a drug called metarrestin in people with cancer that has spread. This trial is for several types of cancer. People with osteosarcoma may be able to take part. Please contact your doctor or the trial team for more information.

Country: United States,
Locations: Fairway, Bethesda,
Trial Type: Interventional
Trial Phase: Phase 1,
Trial Status: Recruiting
Minimum age: 12 Years
Maximum age: -
Key Contact: Murielle Hogu, Udo Rudloff, M.D., (240) 858-3335, (240) 760-6238, murielle.hogu@nih.gov, rudloffu@mail.nih.gov,
Clinical Trial ID: NCT04222413

URL: https://clinicaltrials.gov/ct2/show/record/NCT04222413

Key Information

Everyone in this trial will receive the same treatment.

How the treatment works

Metarrestin targets the peri-nucleolar compartment. This is a marker of cancer spread. This drug has been shown to suppress cancer spread. It is taken as a tablet.
Visit our drugs and interventions page to find out more about this treatment, including how it works and what it’s used for.

Who is the trial for?

The below points are a summary of who can enter the trial.
People must be 18 years of age or older to take part in the trial. People between the ages of 12 and 18 may be eligible. The trial team will discuss this with you.
People who have had a sample of their tumour taken to confirm their cancer diagnosis.
People whose cancer cannot be removed with surgery.
People whose cancer has spread or has returned after removal of the primary tumour
People must have cancer that can be measured according to RECIST 1.1. Your doctor will know this.
People whose cancer has progressed after at least one line of standard chemotherapy. Your doctor will know this.
People who have sufficiently recovered from previous treatment.
People must have a performance status corresponding to a Karnofsky over 70% for participants > 16 years of age and Lansky over 70% for participants ≤ 16 years of age. Your doctor will know this.
People with adequate bone marrow, blood clotting, liver and kidney function. You will have tests to check this.
People of childbearing potential must follow the contraceptive guidelines in the study.
People who can swallow tablets.
People who are willing to have samples of tumour tissue analysed during the study.

Who is the trial not for?

The below points are a summary of who can’t enter the trial.
People who have had minor surgery within 14 days of the start of the trial.
People who have had major surgery or curative radiation treatment within 28 days of the start of the trial.
People who have received palliative radiation treatment within 14 days of the start of the trial.
People who have received any chemotherapy or experimental drug with a half-life less than 72 hours within 14 days of the start of the trial. You doctor will know this.
People who have received any chemotherapy or experimental drug with a half-life more than 72 hours within 28 days of the start of the trial. You doctor will know this.
People who have received a chemotherapy regimen containing an alkylating anti-cancer agent within 28 days of the start of the trial. You doctor will know this.
People taking medications that affect CYP enzymes. Your doctor will know this.
People with heart disease diagnosed within 6 months before the start of the trial. The trial team will discuss this with you.
People with HIV, hepatitis B or hepatitis C.
People who have had any other cancer within the last 3 years. People who have had cervical carcinoma in situ, superficial or non-invasive bladder cancer, or basal cell or squamous cell carcinoma in situ that has been cured are still eligible.
People whose cancer is progressing rapidly which may affect the treatment within the trial. The trial team will discuss this with you.
People whose cancer has spread to the brain or spinal cord or people with brain or spinal cord disorders.
People with acute or chronic infections including tuberculosis.
People with a history of seizures or who are at an increased risk of seizures. The trial team will discuss this with you.
People with medical conditions that may put them at risk or affect the trial. The trial team will discuss this.
People who have previously had a gastric bypass or are fed via a feeding tube.
People who have damage to the intestine from infection, inflammation, trauma or surgery. This includes celiac disease, Crohn’s disease and chronic pancreatitis.
People who are pregnant or breastfeeding.

Disclaimer

ONTEX is intended to supplement, not replace, your healthcare team. Patients should always discuss a clinical trial with their healthcare team. If a patient is eligible for a trial the trial team will be able to provide more in-depth information about the trial so the patient can make an informed decision before taking part. Trial information has been sourced from www.clinicaltrials.gov. The content is then reviewed weekly by the Osteosarcoma Now team. All the trials also have a patient-friendly summary and key information section written by the team at Osteosarcoma Now. We have also included a description of the medications being used in the trial and summarised the inclusion and exclusion criteria in the ‘who is this trial (not) for’ sections. To the best of our knowledge the clinical trial database is up-to-date and accurate.However, we cannot assume any liability for the accuracy or completeness of the information.

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