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Small Molecule

Metarrestin for Advanced Cancer

Phase 1
Recruiting
Led By Udo Rudloff, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 2 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is studying a drug called metarrestin as a possible treatment for metastatic cancer.

Who is the study for?
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.
What is being tested?
The trial is testing Metarrestin's safety and effectiveness at shrinking tumors in patients with metastatic cancers. Patients will take Metarrestin orally for as long as they can tolerate it while undergoing regular health checks including blood tests, heart exams, brain activity assessments, imaging scans like CT or MRI, and possibly tumor biopsies.
What are the potential side effects?
Specific side effects of Metarrestin are not listed but may include typical reactions to cancer drugs such as nausea, fatigue, risk of infection due to immune system impact; organ-specific issues depending on how the drug interacts with different body systems; cognitive changes from brain activity alterations.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 2 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and every 2 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
To determine the Objective Response Rate (ORR) according to Evaluation Criteria (RECIST 1.1) in patients treated with metarrestin at the MTD
To identify the maximum tolerated dose (MTD) of metarrestin in subjects with metastatic solid tumors
Secondary study objectives
To assess progression-free survival (PFS) according to RECIST 1.1
To assess safety and tolerability of metarrestin (Cohort IB1)
To assess safety and tolerability of metarrestin in subjects with metastatic solid tumors
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: 2/Arm 2Experimental Treatment1 Intervention
MTD of metarrestin
Group II: 1/Arm 1Experimental Treatment1 Intervention
Escalating/de-escalation doses of metarrestin

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,928 Previous Clinical Trials
41,018,041 Total Patients Enrolled
Udo Rudloff, M.D.Principal InvestigatorNational Cancer Institute (NCI)
8 Previous Clinical Trials
282 Total Patients Enrolled

Media Library

Metarrestin (Small Molecule) Clinical Trial Eligibility Overview. Trial Name: NCT04222413 — Phase 1
Colorectal Cancer Research Study Groups: 1/Arm 1, 2/Arm 2
Colorectal Cancer Clinical Trial 2023: Metarrestin Highlights & Side Effects. Trial Name: NCT04222413 — Phase 1
Metarrestin (Small Molecule) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04222413 — Phase 1
~33 spots leftby Dec 2026