This trial is active, not recruiting.

Condition androgen deprivation treatment-naïve nonmetastatic prostate cancer
Treatment tak-385
Phase phase 1
Sponsor Takeda
Start date May 2014
End date July 2017
Trial size 30 participants
Trial identifier NCT02141659, TAK-385/TB-AK160108, U1111-1156-6034


To evaluate the tolerability and safety of TAK-385 in patients with androgen deprivation treatment-naïve non-metastatic prostate cancer

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
TAK-385 will be taken orally every morning at least 30 minutes before the first meal of the day. 320-360mg(loading dose), 40-160mg(maintenance dose)
Drug (including placebo)

Primary Outcomes

Does-limiying toxicity(DLT): Does resing phase
time frame: up to 48 weeks
Percentage of participants with markedly abnormal advers events
time frame: up to 48 weeks
Percentage of participants with markedly abnormal clinical laboratory tests
time frame: up to 48 weeks
Percentage of participants with markedly abnormal vital signs
time frame: up to 48 weeks
Percentage of participants with markedly abnormal 12-lead electrocardiogram (ECG) parameters
time frame: up to 48 weeks

Secondary Outcomes

Serum prostate-specific antigen (PSA)
time frame: up to 48 weeks
Plasma concentration of TAK-385
time frame: up to 48 weeks
Serum testosterone concentration
time frame: up to 48 weeks

Eligibility Criteria

Male participants at least 20 years old.

Inclusion Criteria: - 1. Patients judged by the investigator to have the capacity to understand the study and follow the study rules. 2. Patients whose written consent (signature or printed name and personal seal on informed consent form) can be obtained before any study procedures are performed. 3. Japanese male patients 20 or more years of age at the time of informed consent. 4. Patients who, if they have a female partner who could become pregnant, agree to practice appropriate means of contraception from the time of informed consent throughout the entire study treatment period and for 4 months after the last dose of study drug. 5. Patients in stable medical condition, including the absence of acute exacerbations of chronic illnesses, serious infections, or major surgery within 4 weeks (28 days) prior to study treatment initiation. 6. Patients with histologically or cytologically confirmed prostate cancer. 7. Patients whose clinical diagnosis is T1-4 N0 M0, or Tx N0 M0 for patients who have undergone radical prostatectomy. 8. Patients who are considered eligible for hormone therapy for prostate cancer. 9. Patients who have not received hormone therapy (e.g., GnRH agonist, GnRH antagonist, steroidal antiandrogen, non-steroidal androgen) for prostate cancer. 10. Patients who have not undergone surgical castration. 11. Patients with serum testosterone at screening > 150 ng/dL. 12. Patients meeting either of the following criteria for PSA at screening. Untreated prostate cancer: PSA at screening > 4.0 ng/mL Treated* prostate cancer: PSA at screening > 0.2 ng/mL *: Patients who have undergone prostatectomy or either or both of high intensity focused ultrasound therapy or radiotherapy (excluding 125I-brachytherapy) prior to the start of this study. 13. Eastern Cooperative Oncology Group (ECOG) Performance Status [17] of 0 or 1 (Appendix G) 14. Body mass index (BMI*) at screening ≥ 18.0 kg/m2 Exclusion Criteria: - 1. Patients exhibiting symptoms judged related to prostate cancer by the investigator (e.g., bone pain, pelvic pain, ureteral obstruction) who urgently require hormone therapy such as GnRH agonist, GnRH antagonist, or CAB/MAB therapy, chemotherapy, or radiotherapy. 2. Patients who have received 5-alpha reductase inhibitors (except for patients who have been treated for male-pattern alopecias). 3. Patients who have received chemotherapy for prostate cancer (including estramustine). 4. Patients who have received 125I-brachytherapy. 5. Patients who received radiotherapy (except for 125I-brachytherapy) within 16 weeks (112 days) before study treatment initiation. 6. Patients who underwent prostatectomy within 16 weeks (112 days before study treatment initiation. 7. Treatment with any investigational compound within the 4 weeks (28 days) prior to the first dose of study drug or ongoing participation in another experimental trial related to the treatment of prostate cancer. 8. Diagnosis or treatment for another systemic malignancy within 2 years before study treatment initiation, or who had received a diagnosis of another malignancy before that and have evidence of residual disease. Patients with non-melanoma skin cancer or carncinoma in situ who have undergone complete resection will not be excluded from the study. 9. Patients taking drugs with moderate to strong CYP3A4 inhibitory or inducing effects, or any medications, supplements, or food products with P-gp inhibitory effects, in the 2 weeks (14 days) prior to study treatment initiation. 10. Patients who have received TAK-385 in a past clinical study. 11. Patients for whom it would be difficult to collect blood from a peripheral vein. 12. Patients with uncontrolled and clinically significant nervous, circulatory, pulmonary, hepatic, renal, metabolic, gastrointestinal, urogenital, or endocrine disorders, or other abnormalities (except for the targeted disease) that could affect study participation or the study results. Also, patients meeting any of criteria a through c below. A) Patients with uncontrolled diabetes (HbA1C > 8% at screening). However, patients whose HbA1c is brought under control with diabetes medications may be rescreened. B) Patients with uncontrolled hypertension (systolic blood pressure > 150 mmHg and diastolic blood pressure > 90 mmHg at 2 separate measurements taken no more than 60 minutes apart at screening). Patients whose blood pressure is brought under control by antihypertensive medication may be rescreened. C) Patients with myocardial infarction, unstable symptomatic ischemic heart disease, arrhythmias of CTCAE Grade > 2, thromboembolism (deep vein thrombosis, pulmonary embolism, or symptomatic cerebrovascular events), or other heart diseases (e.g., pericardial effusion, restrictive cardiomyopathy). However, chronic stable atrial fibrillation controlled by stable anticoagulant therapy will be allowed. 13. Patients with bilateral hydronephrosis or bladder neck outlet obstruction. 14. Known hypersensitivity to TAK-385, TAK-385 excipients, or GnRH antagonists. 15. Patients with a past history of gastrointestinal tract treatments (including gastrectomy) or gastrointestinal disease that could affect the drug absorption or tolerability (malabsorption, esophageal reflux, peptic ulcer, erosive esophagitis). 16. Patients positive for hepatitis B surface antigens (HBsAg), hepatitis C antibodies (HCV), human immunodeficiency virus (HIV) antibodies, or serologic test for syphilis, or with life-threatening disease other than cancer, at screening. 17. Clinically relevant ECG abnormalities, or the following ECG abnormalities, at screening. - Q-wave infarction, unless identified 6 or more months prior to TAK-385 treatment initiation - QTcF interval > 450 msec (when calculating the QTc interval, Fridericia's equation [QT/RR0.33] will be used) 18. Patients with congenital QT prolongation. 19. Current use of Class 1A or Class 3 antiarrhythmic medications. 20. New York Heart Association Class III or IV heart failure. 21. Patients with clinical laboratory abnormalities suggesting clinically relevant underlying disease, or with any of the following abnormal results, at screening. - Serum creatinine ≥ 2.0 mg/dL - ALT or AST ≥ 1.5 x ULN for the study site - Total bilirubin ≥ 2 x ULN for the study site - Neutrophil count < 1,500/mm3, platelet count < 100,000/μL, hemoglobin < 10.0 g/dL - Results of heart-related tests (creatine kinase MB [CK-MB] and cardiac troponin T) exceeding the study sites reference value. 22. Patients found to have clinical problems on the basis of examination findings, ECG findings, or chest X-ray findings at screening. 23. Patients considered unlikely by investigators to be able to follow the study protocol or considered ineligible for the study by investigators for other reasons

Additional Information

Official title A Phase 1, Randomized, Open-Label Study of TAK-385, an Oral Gonadotropin-Releasing Hormone (GnRH) Antagonist in Japanese Patients With Androgen Deprivation Treatment-Naïve Nonmetastatic Prostate Cancer
Description The objective of this study is to evaluate the tolerability and safety of TAK-385 in patients with androgen deprivation treatment-naïve non-metastatic prostate cancer. This study consists of two parts: Part A, multiple dose-rising phase and Part B, an expansion phase.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Takeda.