Other

PM14 for Solid Tumors

MD Anderson Cancer Center, Houston, TX

PM14Phase 1RecruitingResearch Sponsored by PharmaMar

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Voluntarily signed and dated written informed consent (IC), obtained prior to any specific study procedure.

Age ≥18 years.

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Upfrom 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

Study Summary

This trial is testing a new combination regimen for patients with advanced solid tumors.

Eligible Conditions

Advanced Solid Tumors

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall response rate

Patients with dose limiting toxicities

Secondary outcome measures

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 / 10Eligibility criteria met

Find a site

Who is running the clinical trial?

PharmaMarLead Sponsor

89 Previous Clinical Trials

11,375 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many research subjects are needed for this experiment?

"Yes, if you visit clinicaltrials.gov you'll see that this research is actively looking for test subjects. The original posting was on September 6th, 2017, and the listing was updated on May 23rd, 2020. They need a total of 150 people for the study, which will be conducted at 2 locations."

Answered by AI

What is the primary objective of this clinical trial?

"The main objective of this study is to measure the effect of the medication on patients with dose-limiting toxicities. Secondary objectives include Clinical Benefit Rate, Progression-free Survival, and Duration of Response."

Answered by AI