A Phase 1 interventional study of Relugolix Pill and Ritonavir in Prostate Cancer, Prostate Cancer Metastatic and Prostate Adenocarcinoma, sponsored by University of Chicago. Terminated at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by University of Chicago · Phase 1, Interventional, and Treatment
Researchers leading this study hope to learn about the safety of combining the study drug relugolix with another study drug called itraconazole or ritonavir in prostate cancer. This study is for individuals who have advanced prostate cancer and plans to have medical castration (the use of medications or chemicals to lower hormone production in the testicles). Your participation in this research will last up to 1 month.
The purpose of this research is to gather information on the safety and effectiveness of relugolix in combination with ritonavir or itraconazole. The goal of this research is to find out if combining two medications (relugolix and itraconazole or relugolix and ritonavir) could possibly lead to using less relugolix, which is an expensive drug.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 60 is close to the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →University of Chicago is the lead sponsor of 907 studies on the registry; 182 are open to participants now.
Of its 99 completed or terminated interventional studies of FDA-regulated products, 68 (69%) have results posted.
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Exclusion Criteria:
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
Drug: Relugolix Pill
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
Drug: Relugolix Pill · Drug: Itraconazole
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
Drug: Relugolix Pill · Drug: Ritonavir
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
Drug: Relugolix Pill · Drug: Itraconazole
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
Drug: Relugolix Pill · Drug: Ritonavir
A medication used to treat prostate cancer. Relugolix comes as a tablet to take by mouth. It is usually taken with or without food once daily.
HIV antiviral It can treat HIV infection, which causes AIDS. It does not cure HIV or AIDS, but combinations of drugs may slow the progress of the disease and prolong life.
A drug used to treat fungal infections.
Also known as: Sporanox
Testosterone Suppression of Participants as Assessed by Testosterone Levels
To determine whether the addition of itraconazole and ritonavir to relugolix sustains testosterone suppression as assessed by participant testosterone levels.
Time frame: 1 month post start of treatment
Decrease in Relugolix Levels
To evaluate whether itraconazole or ritonavir significantly decreases relugolix clearance in participants with prostate cancer as assessed by relugolix serum levels on days 8 and 15.
Time frame: 1 month post start of treatment
Reduction in Prostate-Specific Antigens Levels of Participants After Study Treatment
To evaluate the efficacy of itraconazole or ritonavir combined with relugolix in patients with prostate cancer as assessed by a reduction in Prostate-Specific Antigen (PSA) levels of patients after study treatment.
Time frame: 1 month post start of treatment
Rate of Reported Adverse Events Among Participants
To evaluate the safety of itraconazole or ritonavir combined with longer interval relugolix dosing regimens in patients with prostate cancer as assessed by the rate of reported adverse events according to Common Terminology Criteria for Adverse Events (CTCAE) V5.
Time frame: 1 month post start of treatment
This study is terminated, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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