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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
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ every 2 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 2 months
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 moreTrial 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
13,842 Previous Clinical Trials
41,002,902 Total Patients Enrolled
945 Trials studying Breast Cancer
1,543,964 Patients Enrolled for Breast Cancer
Udo Rudloff, M.D.Principal InvestigatorNational Cancer Institute (NCI)
8 Previous Clinical Trials
282 Total Patients Enrolled
1 Trials studying Breast Cancer
190 Patients Enrolled for Breast Cancer
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had cancer other than the one currently being treated.I haven't had cancer treatment recently.I was diagnosed with cardiomyopathy less than 6 months ago.I have been diagnosed with pancreatic, colorectal, or breast cancer.I have a history of seizures or am at high risk for seizures.I am mostly able to care for myself and carry on normal activities.My cancer is growing quickly.My blood clotting levels are within a safe range.My liver tests are within the required range.My kidney function, measured by creatinine levels or eGFR, is within the required range.I agree to use birth control during the study.I weigh more than 35 kg.I am willing to have a biopsy and my cancer can be easily biopsied.I can swallow pills.I am HIV, HCV, or HBV positive and taking antiviral medication.I have brain metastases or brain disorders.I do not have any serious infections, including tuberculosis.I have recovered from previous treatment side effects to a mild level.I do not have any uncontrolled illnesses or conditions.My cancer cannot be surgically removed, has spread, and didn't respond to chemotherapy.I have had gastric bypass, use feeding tubes, or have conditions affecting nutrient absorption.I am a teenager with cancer, but it's not rhabdomyosarcoma.I am an adult with a confirmed solid tumor diagnosis.
Research Study Groups:
This trial has the following groups:- Group 1: 1/Arm 1
- Group 2: 2/Arm 2
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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