A Phase 2 Study to Evaluate the Safety and Efficacy of TAK-385, Together With a Leuprorelin Observational Cohort, in Patients With Prostate Cancer
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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).
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
Study Start Date
Actual Primary Completion Date
Actual Study Completion Date
Resource links provided by the National Library of Medicine
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 Outcome Measures
Safety [ Time Frame: From screening to 30 days after last dose of study drug up to 53 weeks ]
Including vital signs, Physical examination findings, Clinical laboratory test results, and adverse events (AEs) and serious adverse events.
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 ]
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Each patient must meet all of the following inclusion criteria to be enrolled in the study:
Male patients 18 years or older
Histologically or cytologically confirmed diagnosis of prostate adenocarcinoma
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
Appropriate serum testosterone and serum PSA concentration at screening as specified in the protocol
A body mass index (BMI) ≥ 18.0 at screening and/or baseline
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at screening and/or baseline.
Male patients, even if surgically sterilized, who agree to practice effective barrier contraception or agree to practice true abstinence.
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
Suitable venous access for the study-required blood sampling, including PK and PD Sampling
Patients meeting any of the following exclusion criteria are not to be enrolled in the study:
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
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)
Visceral metastases (liver or lung)
Features of the patient's medical condition that may make ADT unnecessary or not indicated.
Scheduled for additional surgical or (salvage) radiation therapy within 6 months after baseline evaluations
History of surgical castration
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
Abnormal screening and/or baseline laboratory values as specified in the protocol
History of any significant cardiac condition within 6 months before receiving the first dose of study drug
ECG abnormalities as specified in the protocol
Congenital long QT syndrome
Current use of Class IA (eg, quinidine, procainamide) or Class III (eg, amiodarone, sotalol) antiarrhythmic medications
Uncontrolled hypertension despite appropriate medical therapy. Patients may be re-screened after referral and further management of hypertension
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)
Treatment with any investigational products within 3 months before the first dose of study drug
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
Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of TAK-385, including difficulty swallowing tablets
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
Admission or evidence of alcohol or drug abuse or use of illicit drugs