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Gonadotropin-releasing hormone (GnRH) antagonist

Relugolix + Itraconazole/Ritonavir for Prostate Cancer

Phase 1

Waitlist Available

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

No Placebo-Only Group

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month post start of treatment for reporting.

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active 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