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Targeted Therapy
PMD-026 for Breast Cancer
Phase 1
Waitlist Available
Research Sponsored by Phoenix Molecular Designs
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Females of childbearing potential must have a negative serum pregnancy test
Age ≥ 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 14 months
Awards & highlights
Study Summary
This trial is testing a new cancer drug to see if it is safe and works well against breast cancer cells.
Who is the study for?
Adults with metastatic breast cancer, specifically triple-negative type that's worsened after standard treatments. Participants must have acceptable organ function and blood counts, not be pregnant or breastfeeding, agree to use contraception, and can't have certain infections or uncontrolled high blood pressure.Check my eligibility
What is being tested?
The trial is testing PMD-026, an oral medication aimed at destroying tumor cells in patients with advanced breast cancer. It examines the drug's safety and how well patients tolerate it. The study involves two parts: dose escalation to find a safe dosage and dose expansion to test its effects further.See study design
What are the potential side effects?
While specific side effects of PMD-026 are not listed here, common ones for cancer drugs include nausea, fatigue, diarrhea, risk of infection due to low blood cell counts, liver issues (elevated enzymes), kidney problems (changes in creatinine levels), and potential heart complications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a woman who can have children and have a negative pregnancy test.
Select...
I am 18 years old or older.
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My breast cancer is triple-negative, has spread, and no standard treatments are effective.
Select...
I agree not to donate sperm during and for 30 days after the study.
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I can take care of myself but might not be able to do heavy physical work.
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My breast cancer has spread and worsened after treatment, with no other beneficial standard treatments available.
Select...
I am a male who is either surgically sterile or will use contraception during and 30 days after the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 14 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 14 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Efficacy in Patients
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Maximum tolerated dose (MTD) of PMD-026
+1 moreSecondary outcome measures
Duration of Response
Effect of food on PMD-026 PK
Plasma Concentration
+1 moreOther outcome measures
PMD-026 Activity in Tissue
PMD-026 pharmacodynamics and RSK signaling
RSK2 Expression
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: PMD-026Experimental Treatment1 Intervention
Oral PMD-026 (dose: 25 - 1000 mg), given daily until disease progression or unacceptable toxicity
Find a Location
Who is running the clinical trial?
Phoenix Molecular DesignsLead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your blood pressure is not well controlled, with numbers higher than 180 over 100.My brain metastases are treated and I've been stable for over 28 days.I had a minor surgery less than a week ago, but my central catheter was placed without waiting.I am a woman who can have children and have a negative pregnancy test.I have serious heart issues, including recent heart failure, unstable angina, heart attack, arrhythmias needing treatment, or a long QTcF interval.I am 18 years old or older.My breast cancer is triple-negative, has spread, and no standard treatments are effective.I agree not to donate sperm during and for 30 days after the study.You have HIV and your CD4+ cell counts are less than 350 cells per microliter.I have been diagnosed with Hepatitis B or C.I have a history of cancer spreading to the lining of my brain and spinal cord.Any side effects from my previous treatments are mild, except for hair loss.I do not have any ongoing serious infections requiring treatment.I had targeted radiation for symptom relief within the last week.It has been less than 28 days since my major surgery.It's been less than 14 days since my last cancer treatment.I am not taking any medications that affect my heart's rhythm.I do not have a serious infection or health condition that would prevent me from receiving treatment.I am postmenopausal, surgically sterile, or will use birth control during and 30 days after the study.Your disease can be measured and evaluated using a specific method called RECISTv1.1.You have a sample of tumor tissue that has been preserved in a specific way.Your disease can be measured using specific guidelines called RECISTv1.1.I am not taking medication that strongly affects liver enzyme activity.I am taking medication that interacts with a specific protein in my body.I am not taking any medications that interact with MATE2K.I have not had radiation treatment in the last 28 days.You have HIV and have had a serious infection related to AIDS.You are unable to follow the study's plan due to personal, family, social, or location-related reasons.I do not have severe stomach or bowel problems that could affect medication absorption.I do not have any other cancers that need treatment within a year.I can take care of myself but might not be able to do heavy physical work.My breast cancer has spread and worsened after treatment, with no other beneficial standard treatments available.Your blood counts, liver enzymes, and kidney function are within normal limits.I am a male who is either surgically sterile or will use contraception during and 30 days after the study.
Research Study Groups:
This trial has the following groups:- Group 1: PMD-026
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 there any capacity remaining in this clinical trial?
"As per the clinicaltrials.gov entry, this medical research is not currently recruiting participants; however it initially commenced on November 14th 2019 and was most recently updated September 26th 2022. Although no longer enrolling patients, there are presently 2361 other trials that are looking for volunteers to join them."
Answered by AI
Is PMD-026 sanctioned by the Food and Drug Administration?
"The safety of PMD-026 is deemed to be low by our team at Power, as it has only just begun Phase 1 clinical trials; thus far there is minimal evidence for its efficacy and security."
Answered by AI
What scientific insights is this clinical trial attempting to elucidate?
"According to the clinical trial's funder, Phoenix Molecular Designs, their primary endpoint is determining Maximum Tolerated Dose (MTD) of PMD-026 over a 12 week period. Secondary outcomes being evaluated include Duration of Response which will be measured from when first response occurs to when disease progresses; Plasma Concentration that will be assessed through pharmacokinetic testing; and Time to Response which will also be determined by changes in patient's health."
Answered by AI
How many facilities are responsible for overseeing this clinical trial?
"Nine clinical trial sites are enrolling patients, such as Columbia University in New york City, UCLA in Los Angeles, and the University of Arizona Cancer Center in Tucson. Additionally, there are 6 other locations taking part."
Answered by AI
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