This trial has been completed.

Condition prostate cancer
Treatments tak-385, 80 mg, tak-385, 120 mg, leuprorelin
Phase phase 2
Sponsor Millennium Pharmaceuticals, Inc.
Start date April 2014
End date January 2016
Trial size 133 participants
Trial identifier NCT02083185, 172837, C27002, U1111-1162-5028


This is a 3-arm, randomized, open-label, parallel group study of TAK-385, together with a leuprorelin observational cohort, in patients with prostate cancer who require first-line androgen deprivation therapy (ADT).

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
80 mg orally daily
tak-385, 80 mg
120 mg orally daily
tak-385, 120 mg
(Active Comparator)
22.5 mg

Primary Outcomes

Rate of effective castration defined as the estimated proportion of patients who have testosterone concentrations < 50 ng/dL at all scheduled visits
time frame: Between Day 1 of Week 5 and Day 1 of Week 25

Secondary Outcomes

time frame: From screening to 30 days after last dose of study drug up to 53 weeks
Prostate-specific antigen (PSA) response at 4 weeks
time frame: Week 5, Day 1
PSA nadir
time frame: During weeks 1-24
Serum PSA concentration
time frame: At the end of Week 12 and Week 24
TAK-385 plasma concentrations for population PK/PD analysis
time frame: Various timepoints in weeks 1-49
Quality-of-life using 25-item Prostate Cancer Module [P25] of the EORTC, Aging Male Survery (AMS), and EORTC QLQ-C30
time frame: At regular intervals during treatment, during 3 month after the end of dosing follow-up, when applicable, and/or at the end-of-study (EOS) visit

Eligibility Criteria

Male participants at least 18 years old.

Inclusion Criteria Each patient must meet all of the following inclusion criteria to be enrolled in the study: 1. Male patients 18 years or older 2. Histologically or cytologically confirmed diagnosis of prostate adenocarcinoma 3. Candidate for androgen deprivation therapy (ADT) for the management of hormone-sensitive prostate cancer with 1 of the following clinical disease states: 1) advanced localized disease not suitable for primary therapy, 2) evidence of prostate-specific antigen (PSA) biochemical or clinical relapse following primary surgery or radiation therapy of curative intent, or 3) newly diagnosed metastatic disease that is asymptomatic or not threatening to vital organs 4. Appropriate serum testosterone and serum PSA concentration at screening as specified in the protocol 5. A body mass index (BMI) ≥ 18.0 at screening and/or baseline 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at screening and/or baseline. 7. Male patients, even if surgically sterilized, who agree to practice effective barrier contraception or agree to practice true abstinence. 8. Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care 9. Suitable venous access for the study-required blood sampling, including PK and PD Sampling Exclusion Criteria Patients meeting any of the following exclusion criteria are not to be enrolled in the study: 1. In patients with advanced, localized M0N1 or M1 disease, the presence of clinically significant symptoms or threat to vital organs requiring immediate GnRH/CAB therapy, chemotherapy, or radiotherapy 2. Previously received ADT for more than 8 months total duration (if ADT was received for 8 months or less, then that ADT must have been completed at least 2 years prior to screening) 3. Visceral metastases (liver or lung) 4. Features of the patient's medical condition that may make ADT unnecessary or not indicated. 5. Scheduled for additional surgical or (salvage) radiation therapy within 6 months after baseline evaluations 6. History of surgical castration 7. Diagnosis of or treatment for another malignancy within the 2 years before the first dose of study drug, or previously diagnosed with another malignancy and have any evidence of residual disease. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection 8. Abnormal screening and/or baseline laboratory values as specified in the protocol 9. History of any significant cardiac condition within 6 months before receiving the first dose of study drug 10. ECG abnormalities as specified in the protocol 11. Congenital long QT syndrome 12. Current use of Class IA (eg, quinidine, procainamide) or Class III (eg, amiodarone, sotalol) antiarrhythmic medications 13. Uncontrolled hypertension despite appropriate medical therapy. Patients may be re-screened after referral and further management of hypertension 14. Known, previously diagnosed human immunodeficiency virus (HIV) infection, active chronic hepatitis B or C, life-threatening illness unrelated to prostate cancer, or any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with participation in this study. Specific screening for chronic viral illness is at the discretion of the site and/or local institutional review board (IRB) 15. Treatment with any investigational products within 3 months before the first dose of study drug 16. A primary family member (spouse, parent, child, or sibling of the patient) is involved in the conduct of the study or is a study site employee 17. Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of TAK-385, including difficulty swallowing tablets 18. Use of any medication, or food products listed in the excluded medications and dietary products table within 2 weeks before the first dose of study drug. Patient must have no history of amiodarone use in the 6 months before the first dose of TAK-385 19. Admission or evidence of alcohol or drug abuse or use of illicit drugs

Additional Information

Official title A Phase 2, Randomized, Open-label, Parallel Group Study to Evaluate the Safety and Efficacy of the Oral GnRH Antagonist TAK-385, Together With a Leuprorelin Observational Cohort, in Patients With Prostate Cancer
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Takeda.