Clinical Trials /

Study of Relugolix in Men With High-Risk Metastatic Castration-Sensitive Prostate Cancer or Metastatic Castration-Resistant Prostate Cancer

NCT04666129

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).

Related Conditions:
  • Prostate Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

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

DrugSynonymsArms
RelugolixMVT-601, TAK-385, T-1331285, RVT-601Relugolix Combination Therapy
AbirateroneZytigaRelugolix Combination Therapy
PrednisoneRelugolix 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

NameTypeDescriptionInterventions
Relugolix Combination TherapyExperimentalParticipants 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