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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
Sponsor:
Information provided by (Responsible Party):
Myovant Sciences GmbH

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Metastatic Castration-Resistant Prostate Cancer Metastatic Castration-Sensitive Prostate Cancer Drug: Relugolix Drug: Abiraterone Drug: Prednisone Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Relugolix Combination Therapy
Participants will receive relugolix in combination with abiraterone plus prednisone for 12 weeks during the study treatment period.
Drug: Relugolix
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.
Other Names:
  • MVT-601
  • TAK-385
  • T-1331285
  • RVT-601

Drug: Abiraterone
Abiraterone (1000 mg [2 x 500 mg tablets]) will be administered orally once daily.
Other Name: Zytiga

Drug: Prednisone
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.




Primary Outcome Measures :
  1. Incidence Of Adverse Events [ Time Frame: Baseline through Week 13 ]

Secondary Outcome Measures :
  1. Mean Testosterone Serum Concentrations At Baseline (Day 1), Week 5, And Week 13 [ Time Frame: Baseline (Day 1), Week 5, and Week 13 ]
  2. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: Clinical Trials at Myovant 650-278-8743 ClinicalTrials@Myovant.com

Locations
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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
Sponsors and Collaborators
Myovant Sciences GmbH
Investigators
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Study Director: Myovant Medical Monitor Myovant Sciences
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Responsible Party: Myovant Sciences GmbH
ClinicalTrials.gov Identifier: NCT04666129    
Other Study ID Numbers: MVT-601-049
First Posted: December 14, 2020    Key Record Dates
Last Update Posted: February 26, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Myovant Sciences GmbH:
mCRPC
mCSPC
Relugolix
Abiraterone
Prednisone
Leuprolide acetate
Additional relevant MeSH terms:
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Prostatic Neoplasms
Hypersensitivity
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Immune System Diseases
Prednisone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents