Study of Relugolix in Men With High-Risk Metastatic Castration-Sensitive Prostate Cancer or Metastatic Castration-Resistant Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT04666129|
Recruitment Status : Recruiting
First Posted : December 14, 2020
Last Update Posted : February 26, 2021
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Castration-Resistant Prostate Cancer Metastatic Castration-Sensitive Prostate Cancer||Drug: Relugolix Drug: Abiraterone Drug: Prednisone||Phase 1|
This is an open-label, single-cohort study to assess the safety and tolerability of relugolix in combination with abiraterone plus prednisone for 12 weeks in men with high-risk mCSPC or mCRPC being treated with standard-of-care leuprolide acetate with abiraterone plus prednisone and in whom abiraterone has been well tolerated (that is, without evidence of hepatotoxicity requiring dose adjustment for abiraterone) for a minimum of 12 weeks.
The study will consist of a 45-day screening period followed by a 12-week treatment period. All participants, either with high-risk mCSPC or mCRPC, are required to have been treated with standard-of-care leuprolide acetate with abiraterone plus prednisone for a minimum of 12 weeks prior to baseline (Day 1). Participants will be transitioned from standard-of-care leuprolide acetate 3-month injection to relugolix; with relugolix treatment initiated the day the next dose of leuprolide acetate (3-month injection) is scheduled for administration with the prior dosing regimen of abiraterone plus prednisone being continued.
In addition to safety and tolerability, the study will also provide safety data as participants transition from injectable leuprolide acetate to treatment with relugolix as the androgen-deprivation component of the treatment.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1, Open-Label, Single-Cohort Safety and Tolerability Study of Relugolix in Combination With Abiraterone Plus Prednisone in Men With High-Risk Metastatic Castration-Sensitive Prostate Cancer or Metastatic Castration-Resistant Prostate Cancer Being Treated With Standard-of-Care Leuprolide and Abiraterone Plus Prednisone|
|Actual Study Start Date :||February 18, 2021|
|Estimated Primary Completion Date :||November 2021|
|Estimated Study Completion Date :||December 2021|
Experimental: Relugolix Combination Therapy
Participants will receive relugolix in combination with abiraterone plus prednisone for 12 weeks during the study treatment period.
Relugolix will be administered orally as a single 360 milligram (mg) loading dose of 3 × 120 mg tablets, followed by a 120 mg dose, taken once daily, at approximately the same time each day.
Abiraterone (1000 mg [2 x 500 mg tablets]) will be administered orally once daily.
Other Name: Zytiga
For participants with mCSPC, a 5 mg dose of prednisone will be administered orally once daily, and for participants with mCRPC, a 5 mg dose of prednisone will be administered orally twice daily.
- Incidence Of Adverse Events [ Time Frame: Baseline through Week 13 ]
- Mean Testosterone Serum Concentrations At Baseline (Day 1), Week 5, And Week 13 [ Time Frame: Baseline (Day 1), Week 5, and Week 13 ]
- Proportion Of Participants With Testosterone Concentrations ≥ 50 ng/dL At Baseline (Day 1), Week 5, And Week 13 [ Time Frame: Baseline (Day 1), Week 5, and Week 13 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04666129
|Contact: Clinical Trials at Myovant||650-278-8743||ClinicalTrials@Myovant.com|
|United States, Arizona|
|Urological Associates of Southern Arizona, P.C.||Recruiting|
|Tucson, Arizona, United States, 85741|
|United States, Maryland|
|Chesapeake Urology Research Associates||Recruiting|
|Baltimore, Maryland, United States, 21204|
|United States, Ohio|
|Clinical Research Solutions||Recruiting|
|Middleburg Heights, Ohio, United States, 44130|
|United States, South Carolina|
|Carolina Urologic Research Center||Recruiting|
|Myrtle Beach, South Carolina, United States, 29572|
|United States, Texas|
|Urology San Antonio||Recruiting|
|San Antonio, Texas, United States, 78229|
|Study Director:||Myovant Medical Monitor||Myovant Sciences|