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Targeted Therapy
PMD-026 for Breast Cancer (Dauntless-1 Trial)
Phase 1 & 2
Recruiting
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
Must not have
History of clinically significant cardiovascular abnormalities including: Congestive heart failure (NYHA classification ≥ 3 in within 6 months of first dose of PMD-026, Unstable angina pectoris, Myocardial infarction within 12 months of study entry, Arrhythmias requiring continued treatment (controlled atrial fibrillation allowed), QTcF interval > 460 msec (using Fridericia's formula)
Central nervous system metastases, unless appropriately treated and neurologically stable for ≥ 28 days
Timeline
Screening 3 weeks
Treatment Varies
Follow Up until pd or death, up to 2 years
Awards & highlights
No Placebo-Only Group
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.
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.
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.
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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.
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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.
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I am a male who is either surgically sterile or will use contraception during and 30 days after the study.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have serious heart issues, including recent heart failure, unstable angina, heart attack, arrhythmias needing treatment, or a long QTcF interval.
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My brain metastases are treated and I've been stable for over 28 days.
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I have been diagnosed with Hepatitis B or C.
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I have a history of cancer spreading to the lining of my brain and spinal cord.
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I do not have any ongoing serious infections requiring treatment.
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I had targeted radiation for symptom relief within the last week.
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It has been less than 28 days since my major surgery.
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I am not taking any medications that affect my heart's rhythm.
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I do not have a serious infection or health condition that would prevent me from receiving treatment.
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I am not taking medication that strongly affects liver enzyme activity.
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I am taking medication that interacts with a specific protein in my body.
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I am not taking any medications that interact with MATE2K.
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I do not have severe stomach or bowel problems that could affect medication absorption.
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I do not have any other cancers that need treatment within a year.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ until pd or death, up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~until pd or death, up to 2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Safety and tolerability of PMD-026 in combination with fulvestrant in patients with HR+/HER2- previously treated breast cancer
Secondary study objectives
Plasma concentration of PMD-026 when administered in combination with fulvestrant
Preliminary anti-tumor activity of PMD-026 when dosed in combination with fulvestrant
Other study objectives
Assess OS
Assess gene expression
Evaluate QT interval and PMD-026 concentrations
Side effects data
From 2021 Phase 3 trial • 693 Patients • NCT0202850773%
Palmar-plantar erythrodysesthesia syndrome
58%
Fatigue
56%
Diarrhea
38%
Hypertension
38%
Nausea
30%
Mucositis
29%
Vomiting
26%
Weight loss
26%
Weight gain
24%
Anorexia
20%
Nail disorder
17%
Back pain
16%
Hypothermia
15%
Constipation
15%
Abdominal pain
14%
Neutrophil count decreased
13%
Dizziness
13%
Upper respiratory infection
13%
Headache
11%
Dyspepsia
10%
Pain in extremity
10%
Fever
10%
Obesity
10%
Dysgeusia
9%
Arthralgia
9%
Bone pain
9%
Anemia
8%
Cough
8%
Pruritus
7%
Flu like symptoms
6%
Pain
4%
Alopecia
2%
Thromboembolic event
2%
Bone fracture
1%
Gastrointestinal infection
1%
Spinal cord compression
1%
Febrile neutropenia
1%
Respiratory infection
1%
Hot flashes
1%
Pancreatitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1 and 2: Capecitabine
Cohort 1: Palbociclib Plus Exemestane
Cohort 2: Palbociclib Plus Fulvestrant
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: Oral PMD-026 in combination with fulvestrantExperimental Treatment2 Interventions
Daily dosing of PMD-026 with fulvestrant dosing according to package insert
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
fulvestrant
2012
Completed Phase 3
~2000
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: Oral PMD-026 in combination with fulvestrant
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.