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Hormone Treatment-naïve Participants With Prostate CancerPhase 1NCT02141659

A Study of TAK-385 in Hormone Treatment-naïve Participants With Prostate Cancer

A Phase 1 study testing TAK-385 in people with Hormone Treatment-naïve Participants With Prostate Cancer, run by Takeda at 6 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the tolerability and safety of TAK-385 in hormone treatment-naïve participants with non-metastatic prostate cancer. Read more about this study

Who is it for?
Ages 20 years and older, men only
What is being tested?
TAK-385
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
43 participants
Where
6 sitesJapan
Study dates
1 May 2014to 20 Apr 2017
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants judged by the investigator to have the capacity to understand the study and follow the study rules.
  • Participants whose written consent (signature or printed name and personal seal on informed consent form) can be obtained before any study procedures are performed.
  • Japanese male participants 20 or more years of age at the time of informed consent.
  • Participants 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.
  • Participants 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.
  • Participants with histologically or cytologically confirmed prostate cancer.
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  • Participants whose clinical diagnosis is T1-4 N0 M0, or Tx N0 M0 for participants who have undergone radical prostatectomy.
  • Participants who are considered eligible for hormone therapy for prostate cancer.
  • Participants who have not received hormone therapy (example, gonadotropin-releasing hormone [GnRH] agonist, GnRH antagonist, steroidal antiandrogen, non-steroidal androgen) for prostate cancer.
  • Participants who have not undergone surgical castration.
  • Participants with serum testosterone at screening greater than (>) 150 nanogram per deciliter (ng/dL).
  • Participants meeting either of the following criteria for prostate-specific antigen (PSA) at screening. Untreated prostate cancer: PSA at screening > 4.0 nanogram per milliliter (ng/mL) Treated* prostate cancer: PSA at screening > 0.2 ng/mL.
  • Participants 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.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status [17] of 0 or 1.
  • Body mass index (BMI) at screening greater than or equal to (>=) 18.0 kilogram per square meter (kg/m^2).

Who cannot join

  • Participants exhibiting symptoms judged related to prostate cancer by the investigator (example, bone pain, pelvic pain, ureteral obstruction) who urgently require hormone therapy such as GnRH agonist, GnRH antagonist, or CAB/MAB therapy, chemotherapy, or radiotherapy.
  • Participants who have received 5-alpha reductase inhibitors (except for participants who have been treated for male-pattern alopecias).
  • Participants who have received chemotherapy for prostate cancer (including estramustine).
  • Participants who have received 125I-brachytherapy.
  • Participants who received radiotherapy (except for 125I-brachytherapy) within 16 weeks (112 days) before study treatment initiation.
  • Participants who underwent prostatectomy within 16 weeks (112 days before study treatment initiation.
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  • 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.
  • 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. Participants with non-melanoma skin cancer or carcinoma in situ who have undergone complete resection will not be excluded from the study.
  • Participants taking drugs with moderate to strong cytochrome P450 3A4 (CYP3A4) inhibitory or inducing effects, or any medications, supplements, or food products with P-glycoprotein (P-gp) inhibitory effects, in the 2 weeks (14 days) prior to study treatment initiation.
  • Participants who have received TAK-385 in a past clinical study.
  • Participants for whom it would be difficult to collect blood from a peripheral vein.
  • Participants 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, participants meeting any of criteria a through c below.
  • Participants with uncontrolled diabetes (Hemoglobin A1c [HbA1C] > 8 percent [%] at screening). However, participants whose HbA1c is brought under control with diabetes medications may be rescreened.
  • Participants with uncontrolled hypertension (systolic blood pressure > 150 millimeter of mercury (mmHg) and diastolic blood pressure > 90 mmHg at 2 separate measurements taken no more than 60 minutes apart at screening). Participants whose blood pressure is brought under control by antihypertensive medication may be rescreened.
  • Participants with myocardial infarction, unstable symptomatic ischemic heart disease, arrhythmias of common terminology criteria for adverse events (CTCAE) Grade > 2, thromboembolism (deep vein thrombosis, pulmonary embolism, or symptomatic cerebrovascular events), or other heart diseases (example, pericardial effusion, restrictive cardiomyopathy). However, chronic stable atrial fibrillation controlled by stable anticoagulant therapy will be allowed.
  • Participants with bilateral hydronephrosis or bladder neck outlet obstruction.
  • Known hypersensitivity to TAK-385, TAK-385 excipients, or gonadotropin-releasing hormone (GnRH) antagonists.
  • Participants 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).
  • Participants 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.
  • Clinically relevant electrocardiogram (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 millisecond (msec) (when calculating the QTc interval, Fridericia's equation [QT/RR0.33] will be used).
  • Participants with congenital QT prolongation.
  • Current use of Class 1A or Class 3 antiarrhythmic medications.
  • New York Heart Association Class III or IV heart failure.
  • Participants 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.
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >= 1.5*upper limit of normal (ULN) for the study site.
  • Total bilirubin >= 2*ULN for the study site.
  • Neutrophil count less than (<) 1,500 per cubic millimeter (/mm^3), platelet count < 100,000 per microliter (/mcL), 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.
  • Participants found to have clinical problems on the basis of examination findings, ECG findings, or chest X-ray findings at screening.
  • Participants considered unlikely by investigators to be able to follow the study protocol or considered ineligible for the study by investigators for other reasons.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Japan6 sites

  • Study site

    Chiyoda-ku, Tokyo

  • Study site

    Kanazawa, Ishikawa-ken

  • Study site

    Maebashi, Gunma

  • Study site

    Sakura-shi, Chiba

  • Study site

    Sapporo, Hokkaido

  • Study site

    Yokohama, Kanagawa

Other trials in Japan

About this study

Official title: A Phase 1, Open-label, Multicenter Study to Evaluate the Tolerability, Safety, Pharmacokinetics, and Pharmacodynamics of TAK-385 Alone in Hormone Treatment- naïve Japanese Patients With Non-metastatic Prostate Cancer

The purpose of this study is to evaluate the tolerability and safety of TAK-385 in hormone treatment-naïve participants with non-metastatic prostate cancer.

Read the detailed description

The objective of this study is to evaluate the tolerability and safety of TAK-385 in hormone treatment-naive participants with non-metastatic prostate cancer. This study consists of two parts: Part A, multiple dose-rising (MRD) phase and Part B, an expansion phase.

Being tested
TAK-385

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TAK-385Drug

    TAK-385 Tablets.

Study groups in NCT02141659
Study groupRoleWhat they receive
Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mgExperimentalTAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 80 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
Receives: Drug: TAK-385
Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mgExperimentalTAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
Receives: Drug: TAK-385
Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mgExperimentalTAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 160 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
Receives: Drug: TAK-385
Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mgExperimentalTAK-385 360 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
Receives: Drug: TAK-385
Part B Cohort 1: TAK-385 320 mg + TAK-385 80 mgExperimentalTAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 80 mg maintenance dose, tablet, orally, once daily through Days 2 to 672.
Receives: Drug: TAK-385
Part B Cohort 2: TAK-385 320 mg + TAK-385 120 mgExperimentalTAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 672.
Receives: Drug: TAK-385

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part A: Number of Participants With Dose-limiting Toxicities (DLTs)

    DLTs were defined as treatment-related adverse events (AEs) that occurred within the first 28 days of treatment as per common terminology criteria for adverse events (CTCAE) version 4.03: any grade 3 or higher toxicity; QT/Fridericia corrected QT (QTcF) greater than (>) 500 millisecond (msec) after treatment initiation; QT/QTcF interval prolongation >60 msec postdose.

    Measured: From treatment initiation until Day 28

  2. Part A: Number of Participants Reporting One or More Treatment-emergent Adverse Event (TEAE)

    Measured: From treatment initiation until 40 days after last dose of study drug (Day 68)

  3. Part A: Number of Participants With Grade 2 or Higher Laboratory Test Abnormalities

    Laboratory test abnormalities were graded using the CTCAE. The grades were: Grade 2- (moderate) minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activity of daily living (ADL); Grade 3- (severe) medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limited self-care ADL. Data has been presented for any Grade 2 or higher event in the laboratory test abnormalities.

    Measured: From treatment initiation until 40 days after last dose of study drug (Day 68)

  4. Part A: Number of Participants With Markedly Abnormal Values of Vital Signs Parameters

    Measured: From treatment initiation until 40 days after last dose of study drug (Day 68)

  5. Part A: Number of Participants With Markedly Abnormal Values of Electrocardiogram (ECG) Parameters

    Measured: From treatment initiation until 40 days after last dose of study drug (Day 68)

  6. Part B: Number of Participants Reporting One or More TEAE

    Measured: From treatment initiation until 40 days after last dose of study drug (Day 712)

  7. Part B: Number of Participants With Grade 2 or Higher Laboratory Test Abnormalities

    Laboratory test abnormalities were graded using the CTCAE. The grades were: Grade 2- (moderate) minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL; Grade 3- (severe) medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limited self-care ADL. Data has been presented for any Grade 2 or higher event in the laboratory test abnormalities. Here aspartate aminotransferase (AST) (glutamic-oxaloacetic transaminase [GOT]) High, creatine kinase (CK) (creatine phosphokinase [CPK]) High, prothrombin time (PT)-international normalized ratio (INR) High.

    Measured: From treatment initiation until 40 days after last dose of study drug (Day 712)

  8. Part B: Number of Participants With Markedly Abnormal Values of Vital Signs Parameters

    Here "BP" is blood pressure.

    Measured: From treatment initiation until 40 days after last dose of study drug (Day 712)

  9. Part B: Number of Participants With Markedly Abnormal Values of ECG Parameters

    Measured: From treatment initiation until 40 days after last dose of study drug (Day 712)

Secondary outcomes (6)

  1. Part A: Cmax: Maximum Observed Plasma Concentration for Unchanged TAK-385 on Day 1, 14 and 28

    Measured: Days 1, 14 and 28 pre-dose and at multiple time points (up to 12 hours for Days 1 and 14; up to 72 hours for Day 28) post-dose

  2. Part A: AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to (Tau) Over the Dosing Interval for Unchanged TAK-385 on Day 1, 14 and 28

    Measured: Days 1, 14 and 28 pre-dose and at multiple time points (up to 12 hours for Days 1 and 14; up to 72 hours for Day 28) post-dose

  3. Part A: Serum Testosterone Concentrations for TAK-385

    Measured: Up to Day 35

  4. Part B: Percent Change From Baseline in PSA Levels on Week 13 Day 1 Last Observation Carried Forward (LOCF)

    Measured: Baseline, and Week 13 Day 1 (LOCF; up to Week 13 Day 1)

  5. Part B: Plasma Concentration of Unchanged TAK-385

    Measured: Up to Week 49 Day 1

  6. Part B: Serum Testosterone Concentrations for TAK-385

    Measured: Up to Week 97 Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2014 (estimated)
  2. Study start1 May 2014
  3. Primary completion20 Apr 2017
  4. Study completion20 Apr 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02141659
Sponsor's protocol ID
TAK-385/TB-AK160108
Other IDs
U1111-1156-6034
Status last verified
Apr 2018
First submitted
15 May 2014
Last updated
19 Nov 2018
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Suzuki H, Uemura H, Mizokami A, Hayashi N, Miyoshi Y, Nagamori S, Enomoto Y, Akaza H, Asato T, Kitagawa T, Suzuki K. Phase I trial of TAK-385 in hormone treatment-naive Japanese patients with nonmetastatic prostate cancer. Cancer Med. 2019 Oct;8(13):5891-5902. doi: 10.1002/cam4.2442. Epub 2019 Aug 19.

    PubMed 31429205

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TAK-385 in people with Hormone Treatment-naïve Participants With Prostate Cancer, run by Takeda at 6 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A: Number of Participants With Dose-limiting Toxicities (DLTs) (time frame: From treatment initiation until Day 28). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02141659, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2018.

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