Metarrestin for Advanced Cancer
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial requires participants to stop taking medications that are moderate or strong inhibitors or inducers of CYP3A4 enzymes before starting the treatment. If you are on such medications, you will need to stop them within a specific time frame based on their half-lives. However, dihydropyridine calcium-channel blockers are allowed.
What makes the drug Metarrestin unique for treating advanced cancer?
Metarrestin is a novel drug that targets a specific protein involved in cancer cell metastasis (spread), which is different from traditional chemotherapy drugs that mainly target rapidly dividing cells. This unique mechanism may offer a new approach for treating advanced cancers that are resistant to other treatments.12345
Research Team
Udo Rudloff, M.D.
Principal Investigator
National Cancer Institute (NCI)
Eligibility Criteria
Adults and children (12-17) with metastatic solid tumors like pancreatic, breast, or colorectal cancer that standard treatments haven't cured. Participants must be over 35 kg in weight, have a certain level of physical ability, and their major organs need to function well. Women who can become pregnant and men must use birth control during the trial.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive metarrestin orally in cycles of 28 days until progression or unacceptable toxicity
Follow-up
Participants have a follow-up visit 30 days after treatment ends, then follow-up phone calls or emails every 6 months
Dose Escalation
Phase IA to determine the maximum tolerated dose (MTD) of metarrestin
Dose Expansion
Phase IB to determine the Objective Response Rate (ORR) at the MTD
Treatment Details
Interventions
- Metarrestin
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor