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JZP341 for Advanced Cancer
Phase 1
Waitlist Available
Research Sponsored by Jazz Pharmaceuticals
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 up to 5 years
Awards & highlights
Study Summary
This trial will test a new drug to see if it is safe and effective for treating advanced cancer.
Who is the study for?
Adults over 18 with advanced or metastatic solid tumors, who have tried standard treatments without success or can't tolerate them. They must be in relatively good health otherwise, not planning to conceive, and willing to use contraception. People with serious heart conditions, certain infections like uncontrolled hepatitis B/C or HIV, pregnant or breastfeeding women, and those with unstable brain tumors are excluded.Check my eligibility
What is being tested?
The trial is testing JZP341's safety and effectiveness on participants with tough-to-treat solid tumors that have spread. It involves adults who've exhausted other options. The study has two parts: finding the right dose of JZP341 and then seeing how well it works at that dose.See study design
What are the potential side effects?
While specific side effects for JZP341 aren't listed here, similar cancer drugs often cause fatigue, nausea, allergic reactions, blood clots or changes in blood counts leading to increased infection risk.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Disease Control Rate (Dose Expansion Phase)
Nadir Serum Asparaginase Activity Response Rate (Dose Finding Phase)
Number of Participants With Dose-Limiting Toxicities (Dose Finding Phase)
+7 moreSecondary outcome measures
Disease Control Rate (Dose Finding Phase)
Duration of Response as Assessed By the Investigator (Dose Finding and Dose Expansion Phases)
Nadir Serum Asparaginase Activity Response Rate (Dose Expansion Phase)
+13 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Dose Finding Phase: JZP341Experimental Treatment1 Intervention
Participants who will receive JZP341 on Day 1 and Day 15 of each 28-day cycle.
Group II: Dose Expansion Phase: JZP341Experimental Treatment1 Intervention
Participants who will receive JZP341 at the RP2D established in the Dose Finding Phase on Day 1 and Day 15 of each 28-day cycle.
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Who is running the clinical trial?
Jazz PharmaceuticalsLead Sponsor
248 Previous Clinical Trials
34,347 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have an uncontrolled hepatitis infection or an immunodeficiency.I have had a blood clot in my brain or keep getting blood clots.I do not have any severe or uncontrolled health conditions.I am currently experiencing significant or uncontrolled bleeding in my stomach or intestines.I can take care of myself and am up and about more than half of my waking hours.I am HIV-positive with a CD4+ count ≥ 300, undetectable viral load, and on effective treatment.My blood clotting, liver, pancreas, and kidney functions are all normal.I have had severe pancreatitis before.I am 18 years old or older.I do not have a serious or uncontrolled infection.My bone marrow is functioning well.I do not have a brain tumor or worsening brain metastases needing more steroids recently.I am a male willing to not donate sperm and either remain abstinent or use contraception.I am not pregnant or breastfeeding, can't become pregnant, or use birth control and have a recent negative pregnancy test.My colorectal cancer has worsened despite previous treatments.I don't have ongoing major side effects from previous cancer treatments, except for mild conditions like nerve pain, muscle pain, tiredness, hair loss, or hormone issues.I have not had serious heart problems in the last 6 months.I have Hepatitis B but it's under control and I'm monitored regularly.I have previously been treated with JZP341 or a similar medication.My cancer is advanced or has spread, and standard treatments haven't worked or aren't suitable for me.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Finding Phase: JZP341
- Group 2: Dose Expansion Phase: JZP341
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.
What potential risks may be associated with the utilization of JZP341 in a dose-expansion phase?
"The safety and efficacy of Dose Expansion Phase: JZP341 has not been extensively tested, so it received the lowest score on our team's scale - 1."
Answered by AI
Is this research currently accepting participants?
"According to the data on clinicaltrials.gov, this research has concluded its recruitment process. Initially posted on December 1st 2022, it was last updated on November 21st 2022; and although it is not actively searching for patients at present time, there are still 2509 other trials that need participants."
Answered by AI
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