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Gonadotropin-releasing hormone (GnRH) antagonist
Relugolix + Itraconazole/Ritonavir for Prostate Cancer
Phase 1
Recruiting
Led By Walter Stadler
Research Sponsored by University of Chicago
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 1 month post start of treatment
Awards & highlights
Summary
This trial aims to understand the safety of combining drugs to treat advanced prostate cancer and reduce hormone production in testicles. It lasts up to 1 month.
Who is the study for?
This trial is for adults with advanced prostate cancer who are planning to start medical castration therapy. They must be able to take oral medication, have a certain level of physical fitness (ECOG ≤2), and normal heart rhythm. People can't join if they've had allergic reactions to similar drugs, need other systemic prostate cancer therapies, have absorption issues or severe illnesses that could limit participation.
What is being tested?
The study tests the safety and effectiveness of combining relugolix with itraconazole or ritonavir in patients with advanced prostate cancer. The aim is to see if this combination allows for lower doses of relugolix, which may reduce costs without compromising treatment efficacy.
What are the potential side effects?
Potential side effects include those commonly associated with relugolix such as hot flashes, fatigue, diarrhea; itraconazole like nausea and rash; and ritonavir including gastrointestinal disturbances and tingling sensations. Specific side effects will depend on the drug combination each participant receives.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 month post start of treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month post start of treatment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Testosterone Suppression of Participants as Assessed by Testosterone Levels
Secondary study objectives
Decrease in Relugolix Levels
Rate of Reported Adverse Events Among Participants
Reduction in Prostate-Specific Antigens Levels of Participants After Study Treatment
Trial Design
5Treatment groups
Experimental Treatment
Group I: Study Group 3bExperimental Treatment2 Interventions
All study participants will receive a starting dose of relugolix (360 mg in the form of three 120 mg tablets) on Day 1 of the 29-day drug administration period. After Day 1, you will receive relugolix on its own or relugolix combined with another medication called itraconazole or ritonavir. The combination of medications you receive, the dosage for each medication, and when you take each medication will be based on the study group you are enrolled in.
Study Group 3b will receive:
* Relugolix (360 mg) on Day 1
* Relugolix (120 mg) on Days 2-4
* Ritonavir (100 mg) on Days 1-14
Group II: Study Group 3aExperimental Treatment2 Interventions
All study participants will receive a starting dose of relugolix (360 mg in the form of three 120 mg tablets) on Day 1 of the 29-day drug administration period. After Day 1, you will receive relugolix on its own or relugolix combined with another medication called itraconazole or ritonavir. The combination of medications you receive, the dosage for each medication, and when you take each medication will be based on the study group you are enrolled in.
Study Group 3a will receive:
* Relugolix (360 mg) on Day 1
* Relugolix (120 mg) on Days 2-4
* Itraconazole (200 mg tablets taken by mouth) on Days 1-14
Group III: Study Group 2bExperimental Treatment2 Interventions
All study participants will receive a starting dose of relugolix (360 mg in the form of three 120 mg tablets) on Day 1 of the 29-day drug administration period. After Day 1, you will receive relugolix on its own or relugolix combined with another medication called itraconazole or ritonavir. The combination of medications you receive, the dosage for each medication, and when you take each medication will be based on the study group you are enrolled in.
Study Group 2b will receive:
* Relugolix (360 mg) on Day 1
* Relugolix (120 mg) on Days 2-7
* Ritonavir (100 mg tablets taken by mouth) on Days 1-14
Group IV: Study Group 2aExperimental Treatment2 Interventions
All study participants will receive a starting dose of relugolix (360 mg in the form of three 120 mg tablets) on Day 1 of the 29-day drug administration period. After Day 1, you will receive relugolix on its own or relugolix combined with another medication called itraconazole or ritonavir. The combination of medications you receive, the dosage for each medication, and when you take each medication will be based on the study group you are enrolled in.
Study Group 2a will receive:
* Relugolix (360 mg) on Day 1
* Relugolix (120 mg) on Days 2-7
* Itraconazole (200 mg) on Days 1-14
Group V: Study Group 1Experimental Treatment1 Intervention
All study participants will receive a starting dose of relugolix (360 mg in the form of three 120 mg tablets) on Day 1 of the 29-day drug administration period. After Day 1, you will receive relugolix on its own or relugolix combined with another medication called itraconazole or ritonavir. The combination of medications you receive, the dosage for each medication, and when you take each medication will be based on the study group you are enrolled in.
Study Group 1 will receive:
* Relugolix (360 mg) on Day 1
* Relugolix (120 mg) on Days 2-7
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ritonavir
2005
Completed Phase 4
~2200
Itraconazole
2017
Completed Phase 2
~830
Find a Location
Who is running the clinical trial?
University of ChicagoLead Sponsor
1,034 Previous Clinical Trials
753,594 Total Patients Enrolled
Walter StadlerPrincipal InvestigatorUniversity of Chicago
7 Previous Clinical Trials
701 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have severe heart failure.I have a condition that affects how my gut absorbs nutrients.I am not currently on a trial drug or have not been within its active period.I need a specific combination therapy for my prostate cancer.I have prostate cancer confirmed by tests and will start hormone therapy.I am 18 years old or older.I am not taking medications that strongly interact with CYP3A4 and P-gp.I can take pills and will follow the medication schedule.I am allergic to medications similar to relugolix, itraconazole, or ritonavir.I am mostly self-sufficient and can carry out daily activities.I do not have any serious illnesses or situations that would stop me from following the study's requirements.
Research Study Groups:
This trial has the following groups:- Group 1: Study Group 3a
- Group 2: Study Group 2b
- Group 3: Study Group 3b
- Group 4: Study Group 1
- Group 5: Study Group 2a
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.
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