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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must be ≥18 years of age at the time of informed consent, with documented RET-altered malignancy
ECOG performance status of 0 or 1 at screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Study Summary
This trial is testing a new drug for people with cancer that has a specific genetic alteration. They want to see if it is safe and effective.
Who is the study for?
Adults over 18 with advanced RET-altered malignancies can join this trial. They should understand their treatment options and be in good physical condition (ECOG status of 0 or 1). Exclusions include active infections needing drugs, severe health issues, certain liver/kidney conditions, recent heart problems, uncontrolled blood pressure, brain metastases unless stable.Check my eligibility
What is being tested?
The study is testing EP0031's safety and effectiveness for tumors with specific genetic changes called 'RET alterations'. It will look at how well patients respond to the drug and what side effects occur.See study design
What are the potential side effects?
While not specified here, common side effects may include reactions at the injection site, fatigue, nausea. Since it targets cancer cells with genetic changes, there might also be risks of abnormal blood tests or organ function.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am over 18 and have a RET-altered cancer diagnosis.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Therapeutic procedure
Modules B and C: Overall Response Rate (ORR) as measured using RECIST v1.1
Secondary outcome measures
Area under the plasma concentration versus time curve (AUC)
Maximum Plasma Concentration (Cmax)
Time taken for drug concentration to fall from half its original value (Half-life)
Trial Design
6Treatment groups
Experimental Treatment
Group I: RET mutation-positive MTC (no prior SRI therapy)Experimental Treatment1 Intervention
EP0031 capsules at the recommended phII dose, taken once daily until progressive disease (PD), unacceptable toxicity or patient withdrawal
Group II: RET mutation-positive MTCExperimental Treatment1 Intervention
EP0031 capsules at the recommended phII dose, taken once daily until progressive disease (PD), unacceptable toxicity or patient withdrawal
Group III: RET fusion-positive NSCLC (no prior SRI therapy)Experimental Treatment1 Intervention
EP0031 capsules at the recommended phII dose, taken once daily until progressive disease (PD), unacceptable toxicity or patient withdrawal
Group IV: RET fusion-positive NSCLCExperimental Treatment1 Intervention
EP0031 capsules at the recommended phII dose, taken once daily until progressive disease (PD), unacceptable toxicity or patient withdrawal
Group V: Other RET-altered solid tumours (no prior SRI therapy)Experimental Treatment1 Intervention
EP0031 capsules at the recommended phII dose, taken once daily until progressive disease (PD), unacceptable toxicity or patient withdrawal
Group VI: Other RET-altered solid tumoursExperimental Treatment1 Intervention
EP0031 capsules at the recommended phII dose, taken once daily until progressive disease (PD), unacceptable toxicity or patient withdrawal
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Who is running the clinical trial?
Ellipses PharmaLead Sponsor
4 Previous Clinical Trials
212 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently on medication for an active infection.I am over 18 and have a RET-altered cancer diagnosis.My liver, kidneys, or bone marrow do not work properly.I am fully active or restricted in physically strenuous activity but can do light work.I have an active hepatitis B or C infection.My cancer does not have major gene changes except for RET.My high blood pressure is not under control.I have chronic kidney inflammation or have had a kidney transplant.I am fully informed about my treatment options, including RET-targeted therapies.I am not taking any strong medication that affects liver enzymes.I do not have any severe or uncontrolled health or mental conditions.I have stable brain metastases or spinal cord compression.I don't have serious heart issues like recent heart attacks or severe heart failure.I have a corneal ulcer.
Research Study Groups:
This trial has the following groups:- Group 1: RET mutation-positive MTC (no prior SRI therapy)
- Group 2: Other RET-altered solid tumours (no prior SRI therapy)
- Group 3: RET fusion-positive NSCLC
- Group 4: RET mutation-positive MTC
- Group 5: Other RET-altered solid tumours
- Group 6: RET fusion-positive NSCLC (no prior SRI therapy)
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 this experiment available to prospective candidates?
"Affirmative. Data hosted on clinicaltrials.gov states that this research is presently seeking participants and was initially posted on the 30th of September 2022, with its last edit occurring on October 25th of the same year. The investigation requires 265 patients from 4 different facilities to be enrolled in it."
Answered by AI
What is the ceiling for participants in this clinical experiment?
"Accurate. According to clinicaltrials.gov, the trial in question is currently recruiting patients, having been posted on September 30th 2022 and updated most recently on October 25th of that same year. 265 participants are required from 4 distinct sites for this medical study."
Answered by AI
In which locations is this research currently being conducted?
"Currently, 4 sites are enrolling participants, including Providence Portland Medical Center in Oregon and MD Anderson Cancer Centre in Texas. Additionally, the David Geffen School of Medicine at UCLA is also partaking in this trial alongside four other medical centres."
Answered by AI
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