A Phase 2 Study to Evaluate the Safety and Efficacy of TAK-385, Together With a Leuprorelin Observational Cohort, in Participants With Prostate Cancer

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Millennium Pharmaceuticals, Inc.
Study ID
NCT02083185
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Relugolix — DRUG
    Relugolix tablets
  • Leuprorelin — DRUG
    Leuprorelin subcutaneous injection

Study Details

The purpose of this study is to evaluate the efficacy of TAK 385 for achieving and maintaining testosterone suppression (\<50 ng/dL).

Key Dates

Start date
Mar 26, 2014
Status verified
Apr 2018
Primary completion
Jan 1, 2016
Completion
Feb 23, 2017

Study Design

Enrollment
136 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Relugolix 80 mg
    Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 80 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator's discretion.
  • Experimental: Relugolix 120 mg
    Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 120 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator's discretion.
  • Active Comparator: Leuprorelin 22.5 mg
    Leuprorelin 22.5 mg, subcutaneous, injection on Day 1 and every 12 Weeks for up to 4 injections (48 weeks).

Primary Outcome Measure

Percentage of Participants With Effective Castration Rate Over 24 Weeks [ Time Frame: Day 1 of Week 5 to Day 1 of Week 25 ]

Locations (19)

FacilityCityStateZIPSite coordinators
-BirminghamAlabama--
-San DiegoCalifornia--
-DenverColorado--
-Daytona BeachFlorida--
-JeffersonvilleIndiana--
-WichitaKansas--
-ShreveportLouisiana--
-OmahaNebraska--
-LawrencevilleNew Jersey--
-Garden CityNew York--
-SyracuseNew York--
-CincinnatiOhio--
-SpringfieldOregon--
-LancasterPennsylvania--
-Myrtle BeachSouth Carolina--
-NashvilleTennessee--
-DallasTexas--
-San AntonioTexas--
-Virginia BeachVirginia--

Find similar trials in Birmingham, AL

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology

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