← Back to Search

Other

PM14 for Advanced Cancer

Phase 1

Recruiting

Research Sponsored by PharmaMar

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

No Placebo-Only Group

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 below

Select...

I am fully active and can carry on all my pre-disease activities without restriction.

Select...

My cancer can be measured by standard health scans.

Select...

I am 18 years old or older.

Select...

I have an advanced solid tumor and no cure is available.

Select...

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.

Select...

I am taking medication that could affect my heart rhythm.

Select...

I am currently being treated for an infection.

Select...

I have had a bone marrow transplant or significant radiation therapy.

Select...

I have a history of heart failure or weak heart muscle.

Select...

I have HIV, hepatitis C, or active hepatitis B.

Select...

I have a heart rhythm problem that needs treatment.

Select...

I am a fertile man not using birth control.

Select...

I have a significant heart valve problem.

Select...

My high blood pressure is not controlled, even with treatment.

Select...

I have a history of long QT syndrome.

Select...

I have cancer cells in the fluid around my brain and spinal cord.

Select...

I am a woman who can have children and am not using birth control.

Select...

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the date of first infusion of study treatment to the date of study termination, assessed up to 72 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

Overall response rate

Patients with dose limiting toxicities

Secondary study objectives

Clinical Benefit Rate

Duration of Response

Incidence of Treatment-Emergent Adverse Events

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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.

0 / 19Eligibility criteria met