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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline until death, withdrawal of consent, or lost to follow-up, up to 18 months after last participant starts study intervention
Awards & highlights
Study Summary
This trial will study a new drug, JZP815, to see if it is safe and effective in treating people with solid tumors that have changes in a cell signaling pathway called the MAPK pathway.
Who is the study for?
Adults with advanced or metastatic solid tumors that have changes in the MAPK pathway can join this trial if they've tried all standard treatments without success, are not pregnant or breastfeeding, agree to use effective contraception, and have a life expectancy of at least 12 weeks. They must be able to undergo tumor biopsies and have good organ function.Check my eligibility
What is being tested?
The study is testing JZP815 oral capsules for safety, proper dosing levels, and initial effectiveness against tumors. It's an early-phase trial (phase 1) focusing on patients whose cancers involve alterations in the MAPK pathway.See study design
What are the potential side effects?
While specific side effects of JZP815 are not listed here, phase 1 trials typically monitor for any adverse reactions including nausea, fatigue, allergic reactions, blood count changes or other unexpected health issues related to the new medication.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline until death, withdrawal of consent, or lost to follow-up, up to 18 months after last participant starts study intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline until death, withdrawal of consent, or lost to follow-up, up to 18 months after last participant starts study intervention
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change From Baseline in Absolute Neutrophil Count (Part A and B)
Alanine Transaminase
Change From Baseline in Aspartate Aminotransferase (Part A and B)
+12 moreSecondary outcome measures
Dose Proportionality of JZP815 and its Metabolites (Part A)
Objective Response Rate (as Defined by RECIST v1.1) (Part A)
Overall Survival (Part B)
+9 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Expansion (Part B): JZP815Experimental Treatment1 Intervention
Participants with advanced or metastatic solid tumors who will receive JZP815 at the RP2D established in Dose Exploration (Part A).
Group II: Dose Exploration (Part A): JZP815Experimental Treatment1 Intervention
Participants will receive JZP815 with a starting dose of 20 mg twice daily (BID).
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Who is running the clinical trial?
Jazz PharmaceuticalsLead Sponsor
248 Previous Clinical Trials
34,027 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any severe or uncontrolled health conditions.I have not had any cancer other than non-spreading skin cancer, early-stage prostate cancer with low PSA, or in-situ cancers in the last 2 years.I have serious heart issues, including recent stroke or heart attack.I am 18 years old or older.I cannot stop taking my acid reflux medication for 2 weeks before starting the trial.My tumor can be safely biopsied with a needle or through surgery.My organs are working well.I am a male and will not donate sperm. I will either remain abstinent or use contraception.I can sign and understand the consent form.I am not using, and can stop using, any strong drugs that affect liver enzymes 4 weeks before the study.My brain metastases are under control, with stable medication for the last 4 weeks.My cancer type and mutations match the study's requirements.I haven't had cancer treatment in the last 28 days or within its half-life period, and I've recovered from any serious side effects.I am not pregnant or breastfeeding, can't become pregnant, or will use effective birth control.My advanced cancer has a MAPK pathway alteration.I am fully active or restricted in physically strenuous activity but can do light work.I have tried all standard treatments without success or cannot tolerate them.I do not have any active infections, including HIV or Hepatitis.I can take and absorb medications without issues.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Exploration (Part A): JZP815
- Group 2: Expansion (Part B): JZP815
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.
Are there any Canadian health care facilities investigating this clinical experiment?
"The Sidney Kimmel Cancer Center located in Philadelphia, Pennsylvania is one of the six sites running this trial. Other locations include Florida Cancer Specialists - Lake Nona in Orlando, Florida and Tennessee Oncology - Nashville situated in Nashville, Tennessee."
Answered by AI
How might the use of Expansion (Part B): JZP815 impact a patient's health?
"The safety of Expansion (Part B): JZP815 was rated a 1 due to the limited clinical evidence supporting its efficacy and security. This is a Phase 1 trial so caution must be taken when administering this medication."
Answered by AI
Are there still available positions to take part in this scientific exploration?
"According to the data hosted on clinicaltrials.gov, this medical trial has been open for recruitment since October 10th 2022 and was last amended on November 14th of the same year."
Answered by AI
How many individuals are being monitored as part of this research endeavor?
"This research requires 320 qualified patients from two sites: Sidney Kimmel Cancer Center in Philadelphia, Pennsylvania and Florida Cancer Specialists - Lake Nona in Orlando."
Answered by AI
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