Clinical trial NCT05679388: A Study of Extending Relugolix Dosing Intervals Through Addition of Itraconazole or Ritonavir in Prostate Cancer Patients
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Prostate Cancer
Prostate Cancer Metastatic
Prostate Adenocarcinoma
Keywords: prostate cancer
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2023-01-11
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

* 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
* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Testosterone Suppression of Participants as Assessed by Testosterone Levels
timeFrame: 1 month post start of treatment
Secondary outcomes:
measure: Decrease in Relugolix Levels
timeFrame: 1 month post start of treatment
measure: Reduction in Prostate-Specific Antigens Levels of Participants After Study Treatment
timeFrame: 1 month post start of treatment
measure: Rate of Reported Adverse Events Among Participants
timeFrame: 1 month post start of treatment
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago Comprehensive Cancer Center
state: Illinois
Study officials:
affiliation: University of Chicago
name: Walter Stadler
role: PRINCIPAL_INVESTIGATOR
References: