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Trial record 1 of 1 for:    TAK-385/TB-AK160108
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This is a Phase 1, Open-label, and Multicenter Study to Evaluate the Tolerability, Safety, Pharmacokinetics, and Efficacy of TAK-385 in Japanese Patients With Androgen Deprivation Treatment-naïve Nonmetastatic Prostate Cancer.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT02141659
First received: May 15, 2014
Last updated: June 2, 2017
Last verified: June 2017
  Purpose
To evaluate the tolerability and safety of TAK-385 in patients with androgen deprivation treatment-naïve non-metastatic prostate cancer

Condition Intervention Phase
Androgen Deprivation Treatment-naïve Nonmetastatic Prostate Cancer Drug: TAK-385 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • 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 ]
    An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug

  • Percentage of participants with markedly abnormal clinical laboratory tests [ Time Frame: up to 48 weeks ]
    The percentage of participants with any markedly abnormal standard safety laboratory values, including hematology, serum chemistries, and urinalysis.

  • Percentage of participants with markedly abnormal vital signs [ Time Frame: up to 48 weeks ]
    Vital signs will include body temperature, sitting blood pressure, and pulse (bpm).

  • Percentage of participants with markedly abnormal 12-lead electrocardiogram (ECG) parameters [ Time Frame: up to 48 weeks ]
    The percentage of participants who meet markedly abnormal criteria specified by the protocol and statistical analysis plan.


Secondary Outcome Measures:
  • 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 ]

Enrollment: 43
Actual Study Start Date: May 16, 2014
Study Completion Date: April 20, 2017
Primary Completion Date: April 20, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TAK-385

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: TAK-385
Drug (including placebo)

Detailed 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.
  Eligibility

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02141659

Locations
Japan
Sakura-shi, Chiba, Japan
Maebashi-shi, Gunma, Japan
Sapporo-shi, Hokkaido, Japan
Kanazawa-shi, Ishikawa, Japan
Yokohama-shi, Kanagawa, Japan
Chiyoda-ku, Tokyo, Japan
Sponsors and Collaborators
Takeda
Investigators
Study Director: Study Manager Takeda
  More Information

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02141659     History of Changes
Other Study ID Numbers: TAK-385/TB-AK160108
U1111-1156-6034 ( Registry Identifier: Universal Trial Number )
Study First Received: May 15, 2014
Last Updated: June 2, 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 22, 2017