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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤1
Patients with measurable or non-measurable disease according to the RECIST v.1.1 during the dose escalation phase
Must not have
Symptomatic, high dose steroid-requiring, and progressing central nervous system (CNS) disease
Concomitant medication with risk of inducing torsades de pointes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the date of first infusion of study treatment to the date of study termination, assessed up to 72 months
Awards & highlights
Summary
This trial tests a new drug called PM14 for patients with advanced cancers that are hard to treat. The goal is to find the safest and most effective dose by adjusting the amount given to avoid severe side effects.
Who is the study for?
This trial is for adults over 18 with advanced solid tumors where no cure exists. It's specifically for those with certain gastrointestinal cancers, sarcomas, or tumors linked to BRCA mutations, among others. Participants should be in relatively good health (ECOG ≤1) and have had a limited number of prior chemotherapy treatments.
What is being tested?
The trial is testing PM14, an investigational drug for patients with advanced solid tumors. The study aims to find new treatment options that are not yet available and may work differently from existing therapies without having completely overlapping side effects.
What are the potential side effects?
While specific side effects of PM14 are not listed here, investigational drugs like this one can potentially cause various reactions depending on their mechanism of action and the individual patient's condition.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active and can carry on all my pre-disease activities without restriction.
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My cancer can be measured by standard health scans.
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I am 18 years old or older.
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I have an advanced solid tumor and no cure is available.
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My cancer has not responded to standard treatments or I cannot tolerate them.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I need high doses of steroids for my worsening brain-related symptoms.
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I am taking medication that could affect my heart rhythm.
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I am currently being treated for an infection.
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I have had a bone marrow transplant or significant radiation therapy.
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I have a history of heart failure or weak heart muscle.
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I have HIV, hepatitis C, or active hepatitis B.
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I have a heart rhythm problem that needs treatment.
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I am a fertile man not using birth control.
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I have a significant heart valve problem.
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My high blood pressure is not controlled, even with treatment.
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I have a history of long QT syndrome.
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I have cancer cells in the fluid around my brain and spinal cord.
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I am a woman who can have children and am not using birth control.
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I am a woman of childbearing potential not using birth control with a fertile partner.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from the date of first infusion of study treatment to the date of study termination, assessed up to 72 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the date of first infusion of study treatment to the date of study termination, assessed up to 72 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Overall response rate
Patients with dose limiting toxicities
Secondary study objectives
Clinical Benefit Rate
Duration of Response
Incidence of Treatment-Emergent Adverse Events
+7 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: PM14Experimental Treatment1 Intervention
Patients will receive PM14 as an i.v. infusion in a total volume of 100 mL of 0.9% sodium chloride at the first three dose escalation levels. Thereafter, the volume of infusion can be increased to 250 mL.
Find a Location
Who is running the clinical trial?
PharmaMarLead Sponsor
91 Previous Clinical Trials
11,623 Total Patients Enrolled
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