Description:
This study is being conducted to assess the safety and tolerability of relugolix in
combination with abiraterone plus prednisone during a 12-week treatment period in men with
metastatic prostate cancer, either metastatic castration-sensitive prostate cancer (mCSPC) or
metastatic castration-resistant prostate cancer (mCRPC).
Title
- Brief Title: Study of Relugolix in Men With High-Risk Metastatic Castration-Sensitive Prostate Cancer or Metastatic Castration-Resistant Prostate Cancer
- 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
Clinical Trial IDs
- ORG STUDY ID:
MVT-601-049
- NCT ID:
NCT04666129
Conditions
- Metastatic Castration-Resistant Prostate Cancer
- Metastatic Castration-Sensitive Prostate Cancer
Interventions
Drug | Synonyms | Arms |
---|
Relugolix | MVT-601, TAK-385, T-1331285, RVT-601 | Relugolix Combination Therapy |
Abiraterone | Zytiga | Relugolix Combination Therapy |
Prednisone | | Relugolix Combination Therapy |
Purpose
This study is being conducted to assess the safety and tolerability of relugolix in
combination with abiraterone plus prednisone during a 12-week treatment period in men with
metastatic prostate cancer, either metastatic castration-sensitive prostate cancer (mCSPC) or
metastatic castration-resistant prostate cancer (mCRPC).
Detailed Description
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Relugolix Combination Therapy | Experimental | Participants will receive relugolix in combination with abiraterone plus prednisone for 12 weeks during the study treatment period. | - Relugolix
- Abiraterone
- Prednisone
|
Eligibility Criteria
Key Inclusion Criteria:
1. A diagnosis of adenocarcinoma of the prostate confirmed by histologic or cytologic
evidence and with a documented medical history of either:
- High-risk, mCSPC defined as having at least two of three risk factors at the
baseline (Day 1) visit:
- Total Gleason score of ≥ 6;
- Presence of ≥ 2 metastatic lesions on bone scan;
- Evidence of measurable visceral metastases with exception of hepatic
metastases.
- mCRPC defined as disease progression despite maintaining castration levels of
testosterone with androgen deprivation therapy:
- An increase in prostate-specific antigen ≥ 25% and ≥ 2 ng/mL above the
nadir, confirmed by 2 measurements at least 3 weeks apart, and;
- The progression of pre-existing disease as evidenced either by worsening
symptoms and/or enlarged metastatic lesions; and/or;
- The development of new metastases.
2. Currently receiving standard-of-care treatment of leuprolide acetate [3-, 4-, or
6-month injections (intramuscular Lupron or subcutaneous Eligard)] and abiraterone
1000 mg once daily plus prednisone 5 mg once daily for participants with mCSPC or
twice daily for participants with mCRPC 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 prior to initiation of the study treatment
period.
Key Exclusion Criteria:
1. Received treatment with a gonadotropin-releasing hormone receptor agonist or
antagonist in combination with abiraterone plus prednisone in high-risk mCSPC
participants for a total duration > 24 months or in mCRPC participants for a total
duration > 6 months.
2. Abnormal clinical laboratory test value(s) suggestive of clinically unstable
underlying disease or a clinical laboratory test value(s) at the screening visit or
prior to the baseline (Day 1) visit including:
- Serum alanine aminotransferase and/or aspartate aminotransferase > upper limit of
normal (ULN) (confirmed twice during screening at least 14 days apart);
- Total bilirubin > ULN (unless values are consistent with Gilbert's syndrome for
which the total bilirubin cannot exceed > 3x ULN);
- Serum creatinine > 2.0 mg/dL;
- Potassium < 3.5 milliequivalents/liter;
- Platelets < 100 × 10^3/microliter (μL);
- Hemoglobin < 10.0 grams/dL;
- Leukocytes < 3 × 10^3/μL;
- Absolute neutrophil count < 1.5 × 10^3/μL;
- Hemoglobin A1c > 8%.
3. A medical history within 6 months prior to the screening visit of the following
(myocardial infarction; unstable angina; unstable symptomatic ischemic heart disease;
New York Heart Association class III or IV heart failure; thromboembolic event[s]) and
any other significant cardiac conditions.
4. An abnormal electrocardiogram finding
5. Uncontrolled hypertension
6. Hypotension
7. Bradycardia
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | Male |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Incidence Of Adverse Events |
Time Frame: | Baseline through Week 13 |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Mean Testosterone Serum Concentrations At Baseline (Day 1), Week 5, And Week 13 |
Time Frame: | Baseline (Day 1), Week 5, and Week 13 |
Safety Issue: | |
Description: | |
Measure: | 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 |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Myovant Sciences GmbH |
Trial Keywords
- mCRPC
- mCSPC
- Relugolix
- Abiraterone
- Prednisone
- Leuprolide acetate
Last Updated
February 26, 2021