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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up start of treatment to the date of progression or the start of a subsequent therapy or end of patient's follow-up, according to the recist v.1.1 and/or serum markers, as appropriate. (up to approximately 36 months)
Awards & highlights
Study Summary
This trial will test a new drug, PM54, for safety and effectiveness in treating advanced solid tumors.
Who is the study for?
This trial is for adults over 18 with advanced solid tumors, including specific cancers of the urinary tract, skin (melanoma), gastrointestinal system, lung, gynecological organs, breast and certain sarcomas. Participants must be in fairly good health otherwise (ECOG ≤1).Check my eligibility
What is being tested?
PM54's safety and maximum tolerated dose are being tested first. Then its effectiveness against tumor growth will be assessed using imaging criteria (RECIST v.1.1) or serum markers in patients with selected advanced solid tumors.See study design
What are the potential side effects?
Possible side effects include reactions related to the dosage of PM54 which may affect different body systems but specifics will become clearer as the trial progresses through its phases.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ start of treatment to the date of progression or the start of a subsequent therapy or end of patient's follow-up, according to the recist v.1.1 and/or serum markers, as appropriate. (up to approximately 36 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~start of treatment to the date of progression or the start of a subsequent therapy or end of patient's follow-up, according to the recist v.1.1 and/or serum markers, as appropriate. (up to approximately 36 months)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase 1a: Dose reductions
Phase 1a: Dose-limiting toxicities (DLTs)
Phase 1a: Drug-related Adverse Events (AEs)
+8 moreSecondary outcome measures
Phase 1b: Adverse events (AEs)
Phase 1b: Concentration in urine samples
Phase 1b: Dose reductions
+10 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: PM54Experimental Treatment1 Intervention
Phase Ia (dose escalation) stage: Patients will receive PM54 i.v. at a starting dose of 0.3 mg/m2.
Phase Ib (expansion) stage: Patients will receive PM54 i.v. at the RD determined during the Phase Ia stage.
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Who is running the clinical trial?
PharmaMarLead Sponsor
90 Previous Clinical Trials
11,412 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an advanced solid tumor with no standard treatment options.I do not have major illnesses or conditions that would interfere with the treatment.I am 18 years old or older.My diagnosis is confirmed by lab tests.I have received the standard treatments for my type of cancer.I am fully active or can carry out light work.My side effects from previous treatments have mostly gone away.I have not received albumin transfusions to boost my blood levels.
Research Study Groups:
This trial has the following groups:- Group 1: PM54
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is PM54 a reliable method of care for patients?
"There is limited clinical data regarding PM54's safety and efficacy, thus it received a rating of 1."
Answered by AI
Is the enrollment period for this clinical trial currently open?
"Records on clinicaltrials.gov show that this medical trial is actively recruiting subjects. The study was first published on May 1st 2023 and the data was most recently updated on April 21st 2023."
Answered by AI
How many individuals are being enrolled in this experiment?
"Affirmative. Clinicaltrials.gov data reveals that this research project, which was first published on May 1st 2023 is presently recruiting participants. 125 individuals need to be recruited from 3 different healthcare centres."
Answered by AI
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