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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Normal Thyroid function
Liver function tests less than or equal to twice upper limit of normal
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion 28 days
Awards & highlights
Study Summary
This trial tests a new drug for advanced lung cancer to see if it's safe and effective.
Who is the study for?
Adults over 18 with advanced non-small cell lung cancer who have tried all standard treatments without success. They must not be pregnant, agree to birth control, and abstain from alcohol and supplements. Participants need a life expectancy of more than 2 months, adequate organ function, no serious medical conditions or infections, and the ability to swallow capsules.Check my eligibility
What is being tested?
The trial is testing RH324, an oral medication for advanced non-small cell lung cancer. It's a phase 1 study which means it's early in testing and focuses on finding the right dose. Patients will take this drug to see how well it works and what doses are safe.See study design
What are the potential side effects?
Since RH324 is new and in Phase 1 testing, specific side effects aren't fully known yet. Generally, such trials look out for any signs of toxicity like nausea, fatigue or allergic reactions as they gradually increase the dose.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My thyroid function is normal.
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My liver tests are within normal limits.
Select...
My kidneys are functioning well enough to clear waste.
Select...
I have advanced non-small cell lung cancer.
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All standard treatments like chemotherapy have not worked for me.
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I can take care of myself but might not be able to do heavy physical work.
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I am scheduled for a PET/CT scan as part of my initial treatment plan.
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I have never had an overactive thyroid.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion 28 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion 28 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Adverse Events Per Common Terminology Criteria for Adverse Events Version 5
Secondary outcome measures
Percentage of Subjects with a Change from Baseline in Quality of Life
Percentage of Subjects with a Change from Baseline on Laboratory Values
Percentage of Subjects with a Change from Baseline on Physical Examination and Vital Signs
+1 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Dose Level 3Experimental Treatment1 Intervention
RH324
Group II: Dose Level 2Experimental Treatment1 Intervention
RH324
Group III: Dose Level 1Experimental Treatment1 Intervention
RH324
Find a Location
Who is running the clinical trial?
ReHeva Biosciences,Inc.Lead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My thyroid function is normal.You should not consume alcohol or dietary supplements.I need medication that strongly affects liver enzyme activity.I have risk factors for heart disease.I do not have any unstable health conditions.I have been diagnosed with phenylketonuria.I cannot swallow pills.I need radiation therapy.I have used Withania somnifera before.My liver tests are within normal limits.I need regular transfusions, dialysis, or similar procedures.You are expected to live for more than 2 months.I currently have an infection.My kidneys are functioning well enough to clear waste.Your blood creatinine level is less than or equal to 2.You are allergic to the ingredients in the study drug.I do not have any mental or neurological conditions that prevent me from participating.Your hemoglobin level is at least 9, your neutrophil count is at least 1,000, and your platelet count is at least 50,000.I have advanced non-small cell lung cancer.All standard treatments like chemotherapy have not worked for me.Your hemoglobin A1C level is lower than 7.I am over 18 years old.I can take care of myself but might not be able to do heavy physical work.I need IV fluids or nutritional support.I am HIV positive.I am scheduled for a PET/CT scan as part of my initial treatment plan.You have a tumor that can be accurately measured using specific guidelines.I have never had an overactive thyroid.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Level 1
- Group 2: Dose Level 2
- Group 3: Dose Level 3
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.
Has Dose Level 1 been certified by the FDA?
"There is minimal evidence of the safety and efficacy of Dose Level 1, which has been assessed by our team at Power with a score of 1."
Answered by AI
Is recruitment currently available for this experiment?
"According to the official record on clinicaltrials.gov, this medical trial was initially made available to patients on June 1st 2022 and has seen regular updates as recently as October 13th 2022; suggesting that enrollment is still open."
Answered by AI
How many participants have been given the green light for this investigation?
"Affirmative. Clinicaltrials.gov hosts data that verifies this medical study is actively searching for participants. It was first posted June 1st of 2022 and has since been updated on October 13th of the same year, seeking 6 volunteers from a single site."
Answered by AI
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