Prostate CancerPhase 1NCT05679388
A Study of Extending Relugolix Dosing Intervals Through Addition of Itraconazole or Ritonavir in Prostate Cancer Patients
A Phase 1 study testing Relugolix Pill, Ritonavir and Itraconazole in people with Prostate Cancer and Prostate Cancer Metastatic, run by University of Chicago at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Prostate Cancer Metastatic, Prostate Adenocarcinoma
- What is being tested?
- Relugolix Pill, Ritonavir and Itraconazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2023to 5 Aug 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must have histologically or cytologically confirmed prostate cancer with plans to start medical castration therapy.
- Age 18 or older. Because no dosing or adverse event data are currently available on the use of relugolix in combination with itraconazole or ritonavir in patients <18 years of age, children are excluded from this study.
- Eastern Cooperative Oncology Group performance status ≤2 (Karnofsky ≥60%)
- Participants must satisfy the following laboratory criteria:
- Testosterone > 200 ng/dl
- QTc within normal limits
Show all 9Show fewer
- Aspartate Transferase (AST)/alanine transaminase (ALT) < 3x upper limit of normal
- Ability to take oral medication and be willing to adhere to the medication regimen.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Need for combination systemic therapy for prostate cancer including docetaxel and/or second-generation androgen receptor pathway targeted agents (i.e. abiraterone, enzalutamide, apalutamide, darolutamide, etc).
- Concurrent therapy with strong interacting drugs with CYP3A4 and P-gp (See Appendix list of strong inhibitors or inducers) due to concerning possible drug-drug interactions with itraconazole, ritonavir and relugolix. Potential drug-drug interactions will also be reviewed by study investigators prior to enrollment.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to relugolix, itraconazole or ritonavir.
- Patients receiving treatment with another investigational drug or other intervention within 3 expected half-lives of the agent.
- Serious or uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements.
- New York Heart Association Class III of IV congestive heart failure
- Known gastrointestinal malabsorption.
- Active psychiatric illness/social situations that would limit compliance with protocol requirements.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60453
About this study
Official title: A Phase Ib Study of Extending Relugolix Dosing Intervals Through Addition of the CYP3A4 and Pg-P Inhibitor Itraconazole or Ritonavir in Prostate Cancer Patients
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.
- Being tested
- Relugolix Pill, Ritonavir, Itraconazole
- Keywords
- prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relugolix PillDrug
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.
RitonavirDrug
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.
ItraconazoleDrug
Also called Sporanox
A drug used to treat fungal infections.
| Study group | Role | What they receive |
|---|---|---|
| Study Group 1 | Experimental | 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 Receives: Drug: Relugolix Pill |
| Study Group 2a | Experimental | 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 Receives: Drug: Relugolix Pill; Drug: Itraconazole |
| Study Group 2b | Experimental | 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 Receives: Drug: Relugolix Pill; Drug: Ritonavir |
| Study Group 3a | Experimental | 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 Receives: Drug: Relugolix Pill; Drug: Itraconazole |
| Study Group 3b | Experimental | 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 Receives: Drug: Relugolix Pill; Drug: Ritonavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month post start of treatment
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 1 month post start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2023
- Study start13 Feb 2023
- Primary completion5 Aug 2024
- Study completion5 Aug 2024
Why it stopped: Terminated by the PI
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Walter Stadler, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05679388
- Sponsor's protocol ID
- IRB22-1150
- Status last verified
- Oct 2023
- First submitted
- 23 Dec 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib Study of Extending Relugolix Dosing Intervals Through Addition of the CYP3A4 and Pg-P Inhibitor Itraconazole or Ritonavir in Prostate Cancer Patients
- ClinicalTrials.gov ID
- NCT05679388
- Acronym / sponsor ID
- IRB22-1150
- Keywords
- prostate cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated by the PI
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 13 Feb 2023 (actual)
- Primary completion
- 5 Aug 2024 (actual)
- Study completion
- 5 Aug 2024 (actual)
- First posted
- 11 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Study Group 1 | Experimental | Drug: Relugolix PillAll 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 |
| Study Group 2a | Experimental | Drug: Relugolix Pill, Drug: ItraconazoleAll 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 |
| Study Group 2b | Experimental | Drug: Relugolix Pill, Drug: RitonavirAll 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 |
| Study Group 3a | Experimental | Drug: Relugolix Pill, Drug: ItraconazoleAll 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 |
| Study Group 3b | Experimental | Drug: Relugolix Pill, Drug: RitonavirAll 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Must have histologically or cytologically confirmed prostate cancer with plans to start medical castration therapy.
- Age 18 or older. Because no dosing or adverse event data are currently available on the use of relugolix in combination with itraconazole or ritonavir in patients <18 years of age, children are excluded from this study.
- Eastern Cooperative Oncology Group performance status ≤2 (Karnofsky ≥60%)
- Participants must satisfy the following laboratory criteria:
- Testosterone > 200 ng/dl
Key exclusion criteria (8 listed)
- Need for combination systemic therapy for prostate cancer including docetaxel and/or second-generation androgen receptor pathway targeted agents (i.e. abiraterone, enzalutamide, apalutamide, darolutamide, etc).
- Concurrent therapy with strong interacting drugs with CYP3A4 and P-gp (See Appendix list of strong inhibitors or inducers) due to concerning possible drug-drug interactions with itraconazole, ritonavir and relugolix. Potential drug-drug interactions will also be reviewed by study investigators prior to enrollment.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to relugolix, itraconazole or ritonavir.
- Patients receiving treatment with another investigational drug or other intervention within 3 expected half-lives of the agent.
- Serious or uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Relugolix PillA 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. | Drug | Study Group 1, Study Group 2a, Study Group 2b, Study Group 3a, Study Group 3b |
| RitonavirHIV 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. | Drug | Study Group 2b, Study Group 3b |
| ItraconazoleAlso: SporanoxA drug used to treat fungal infections. | Drug | Study Group 2a, Study Group 3a |
Primary outcome
Testosterone Suppression of Participants as Assessed by Testosterone Levels
Time frame: 1 month post start of treatment
To determine whether the addition of itraconazole and ritonavir to relugolix sustains testosterone suppression as assessed by participant testosterone levels.
3 secondary outcomes
Decrease in Relugolix Levels
Time frame: 1 month post start of treatment
Reduction in Prostate-Specific Antigens Levels of Participants After Study Treatment
Time frame: 1 month post start of treatment
Rate of Reported Adverse Events Among Participants
Time frame: 1 month post start of treatment
Results and safety
The study was stopped early (reason given: Terminated by the PI). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
Related trials for Prostate Cancer
Not yet recruitingObservational study
Assessment of Intelligent Algorithms for Detection, Diagnosis and Risk Stratification of Tumors of the Kidney and Prostate
Kidney Cancers, Prostate Cancer
Not yet recruiting
WATER IV PCa (AS Sub-study)
Localized Prostate Cancer
Recruiting
The Application of Somatosensory Interactive Pelvic Floor Muscle Training for Stress Urinary Incontinence in Men Underwent Radical Prostatectomy
Prostate Cancer (Post Prostatectomy)
RecruitingPhase 1
A Study of [225Ac]Ac-AKY-2519 in Patients With Metastatic Castration-Resistant Prostate Cancer
Castration Resistant Metastatic Prostate Cancer, Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Walter Stadler principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Relugolix Pill, Ritonavir and Itraconazole in people with Prostate Cancer and Prostate Cancer Metastatic, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Terminated by the PI). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Testosterone Suppression of Participants as Assessed by Testosterone Levels (time frame: 1 month post start of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024; AzTrials last refreshed its copy on 2 Nov 2026.