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Prostate CancerPhase 2NCT02135445

Safety and Efficacy of TAK-385 for Patients With Localized Prostate Cancer

A Phase 2 study testing TAK-385 and Degarelix in people with Prostate Cancer, run by Millennium Pharmaceuticals, Inc. at 25 sites in 2 countries.

Completed

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

Official record
Search all trials

Trial summary

The purpose of this study is to evaluate the efficacy of TAK-385 for achieving and maintaining testosterone suppression. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
TAK-385 and Degarelix
Could I receive a placebo?
No, everyone receives an active treatment
How many people
103 participants
Where
25 sitesin 2 countries
Study dates
Jun 2014to Dec 2015
Phase
Phase 2
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 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Is male, 18 years of age or older.
  • Has histologically confirmed diagnosis of localized prostate adenocarcinoma of intermediate risk for which 6-month neoadjuvant and adjuvant androgen deprivation therapy (ADT) to EBRT is indicated. Intermediate risk per National Comprehensive Cancer Network (NCCN) guidelines includes one of the following:
  • T2b-T2c disease, or
  • Gleason score 7, or
  • Prostate-specific antigen (PSA) 10-20 nanogram per milliliter (ng/mL).
  • Is scheduled for EBRT to begin greater than or equal to (>=) 12 weeks after the Baseline visit.
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  • Has serum testosterone at screening greater then (>) 150 nanogram per deciliter (ng/dL) (5.2 nanomoles per liter [nmol/L]).
  • Has screening serum PSA concentration >2 ng/mL.
  • Has body mass index (BMI) >=18.0 at screening or baseline.
  • Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at screening or baseline.
  • Is a male participant, even if surgically sterilized (that is, status postvasectomy), who: Agrees to practice effective barrier contraception during the entire study treatment period and through 4 months after the last dose of study drug, or, Agrees to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [example, calendar, ovulation, symptothermal, postovulation methods for the female partner] and withdrawal are not acceptable methods of contraception.).
  • Has given voluntary written consent before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to future medical care.
  • Has suitable venous access for the study-required blood sampling, including pharmacokinetic (PK) and pharmacodynamic sampling.

Who cannot join

  • Has metastatic disease (based on investigator evaluation and assuming no likely metastatic pelvic lymph nodes >1.0 cm in long axis diameter).
  • Had prior or current use of a gonadotropin-releasing hormone (GnRH) analog or androgen receptor antagonist as first-line hormone therapy, unless total use was less than 6 months and not more recently than 1 year before the planned baseline visit.
  • Had diagnosis of or treatment for another malignancy within 2 years before the first dose of study drug, or previous diagnosis of another malignancy with evidence of residual disease. Participants with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
  • Has abnormal screening and/or baseline laboratory values that suggest a clinically significant underlying disease, or the following laboratory values:
  • Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >1.5 * institutional upper limit of the normal range (ULN);
  • Serum creatinine >2.0 milligram per deciliter (mg/dL);
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  • Total bilirubin >2.0 * institutional ULN (unless documented Gilbert's disease);
  • Uncontrolled diabetes (Hemoglobin A1c [HbA1c] >10 [percent] %) or previously undiagnosed diabetes mellitus with HbA1c >8%.
  • Has history of myocardial infarction, unstable symptomatic ischemic heart disease, any ongoing cardiac arrhythmias of Grade >2 (chronic stable atrial fibrillation on stable anticoagulant therapy is allowed), thromboembolic events (example, deep vein thrombosis, pulmonary embolism, or symptomatic cerebrovascular events), or any other significant cardiac condition (example, pericardial effusion, restrictive cardiomyopathy) within 6 months before receiving the first dose of study drug.
  • Has electrocardiogram (ECG) abnormalities of:
  • Q-wave infarction, unless identified 6 or more months before screening;
  • Heart rate-corrected QT interval millisecond (msec) (QTcF interval) >480 msec. If QTcF is prolonged in a participant with a pacemaker, the participant may be enrolled in the study upon discussion with the project clinician;
  • If the QTcF interval is 450-480 msec, inclusive, in a participant with current use of medications with known effects on QT interval, the participant may be enrolled in the study following discussion with the project clinician.
  • Has congenital long QT syndrome.
  • Is currently using Class IA (example, quinidine, procainamide) or Class III (example, amiodarone, sotalol) antiarrhythmic medications.
  • Has uncontrolled hypertension despite appropriate medical therapy (sitting blood pressure [BP] of greater than 160 millimeters of mercury (mmHg) systolic and 90 mmHg diastolic at 2 separate measurements no more than 60 minutes apart during the Screening visit). Participants with systolic BP measurements >160 mmHg may be rescreened. Participants with systolic BP measurements 141-160 mmHg, although eligible, should be referred for further management of hypertension if indicated.
  • Has 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).
  • Has received treatment with any investigational products within 3 months before the first dose of study drug.
  • Is a primary family member (spouse, parent, child, or sibling) of anyone involved in the conduct of the study or is a study site employee.
  • Has known gastrointestinal (GI) disease, condition or procedure that could interfere with the oral absorption or tolerance of TAK-385, including difficulty swallowing tablets.
  • Is using any medication or food products listed in the excluded medications and dietary products table within 2 weeks before the first dose of study drug. This list includes moderate and strong inhibitors or inducers of cytochrome P450 (CYP3A4/5) and P-glycoprotein (P-gp). Participants must have no history of amiodarone use in the 6 months before the first dose of TAK-385.
  • Has admission or evidence of alcohol or drug abuse or use of illicit drugs.

Trial locations and contacts

25 sites in 2 countries.

25 sites in 2 countries

United States19 sites

  • Study site

    Birmingham, Alabama

  • Study site

    Bradenton, Florida

  • Study site

    Columbus, Ohio

  • Study site

    Dallas, Texas

  • Study site

    Daytona Beach, Florida

  • Study site

    Denver, Colorado

  • Study site

    Eugene, Oregon

  • Study site

    Fort Lauderdale, Florida

  • Study site

    Fort Myers, Florida

  • Study site

    Jeffersonville, Indiana

  • Study site

    Myrtle Beach, South Carolina

  • Study site

    Omaha, Nebraska

  • Study site

    Plantation, Florida

  • Study site

    San Antonio, Texas

  • Study site

    San Diego, California

  • Study site

    Shreveport, Louisiana

  • Study site

    Syracuse, New York

  • Study site

    Virginia Beach, Virginia

  • Study site

    Wichita, Kansas

Other trials in United States

United Kingdom6 sites

  • Study site

    Birmingham, West Midlands

  • Study site

    Brighton, East Sussex

  • Study site

    Manchester, Greater Manchester

  • Study site

    Metropolitan Borough of Wirral, Merseyside

  • Study site

    Sutton, Surrey

  • Study site

    Taunton, Somerset

Other trials in United Kingdom

About this study

Official title: A Phase 2, Randomized, Open-Label, Parallel Group Study Evaluating the Safety and Efficacy of TAK-385, an Oral Gonadotropin-Releasing Hormone (GnRH) Antagonist, for Patients With Localized Prostate Cancer Requiring Neoadjuvant and Adjuvant Androgen Deprivation Therapy With External Beam Radiation Therapy (EBRT)

The purpose of this study is to evaluate the efficacy of TAK-385 for achieving and maintaining testosterone suppression.

Read the detailed description

The drug being tested in this study is called TAK-385. Men with prostate cancer benefit from receiving androgen deprivation therapy (ADT) to minimize testosterone levels before, during and after EBRT. This combination increases the potential success of treating their disease. This study will see if TAK-385 [an oral gonadotropin-releasing hormone (GnRH) antagonist] brings testosterone levels down sufficiently, with the convenience and comfort of taking a pill. It will look at the time it takes to restore testosterone levels after radiation therapy as well. One hundred participants will be assigned by chance (like flipping a coin) to a treatment group: 60 to TAK-385, and 40 to degarelix.

Those assigned to TAK-385 will take a daily pill. Those assigned to degarelix will receive an injection under the skin once every four weeks at the clinic. They will start radiation therapy when testosterone is low enough, after at least 12 weeks of treatment. This trial will be conducted at clinics in the United States (US) and United Kingdom (UK). Participants will visit the clinic up to 14 times over 37 weeks for physical exams and blood tests, and might receive one follow-up telephone call.

Conditions
Prostate Cancer
Being tested
TAK-385, Degarelix
Keywords
Drug therapy
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • TAK-385Drug

    TAK-385 tablet

  • DegarelixDrug

    Also called Firmagon®

    Degarelix injection

Study groups in NCT02135445
Study groupRoleWhat they receive
TAK-385ExperimentalTAK-385 320 mg, tablets, orally, once, on Day 1, followed by TAK-385 120 mg, orally, once daily for 24 weeks. Each participant may have one upward dose adjustment of 40 mg for efficacy and/or one downward dose adjustment of 40 mg for safety during the study.
Receives: Drug: TAK-385
DegarelixActive comparatorDegarelix 240 mg, injection, subcutaneous, on Day 1, followed by degarelix 80 mg, injection, subcutaneous, once every four weeks, for 24 weeks.
Receives: Drug: Degarelix

What is being measured

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

  1. Percentage of Participants With Effective Castration Rate Over 25 Weeks

    Castration rate is defined as the observed percentage of participants who have testosterone concentrations less than (<) 50 nanogram per deciliter (ng/dL) (1.73 nanomole per liter [nmol/L]) at all scheduled visits.

    Measured: Day 1 Week 5 up to Day 1 Week 25

Secondary outcomes (22)

  1. Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Vital Signs

    Measured: Baseline up to Week 29

  2. Number of Participants With TEAEs Related to Physical Findings

    Measured: Baseline up to Week 29

  3. Number of Participants With TEAEs Related to 12-lead Electrocardiogram (ECG) Findings

    Measured: Baseline up to Week 29

  4. Number of Participants With TEAEs Categorized Into Investigations Related to Chemistry, Hematology or Urinalysis

    Measured: Baseline up to Week 29

  5. Number of Participants Reporting One or More TEAEs and Serious Adverse Events (SAEs)

    Measured: Baseline up to Week 29

  6. Average Percent Change in Prostate Size

    Percent change in prostate size was assessed at a follow up visit between Day 1 Week 9 to Day 1 Week 13.

    Measured: Baseline, Day 1 Week 9 to Day 1 Week 13

  7. Time to Achieve Effective Castration

    Time to effective castration is defined as days from first dose to first testosterone measurement that is <50 ng/dL.

    Measured: Baseline up to Week 37

  8. Time to Achieve Profound Castration

    Time to profound castration is defined as days from first dose to first testosterone measurement that is <20 ng/dL.

    Measured: Baseline up to Week 37

  9. Estimated Time to Testosterone Recovery (TTR)

    TTR is defined as the time from 1 day after the last dose of TAK-385 or 4 weeks plus 1 day after the last dose of degarelix to testosterone recovery. Testosterone recovery is defined as back to baseline or >280 ng/dL whichever occurs first. TTR was determined during 12 weeks after the discontinuation of androgen deprivation therapy (ADT).

    Measured: Up to Day 1 Week 37

  10. Percentage of Participants Who Have Recovered to Baseline Value of Testosterone

    Measured: Up to Day 1 Week 37

  11. Percentage of Participants Who Have Recovered to >280 ng/dL Testosterone

    Measured: Day 1 Week 25 up to Day 1 Week 37

  12. Number of Participants With PSA Response of >=50% and >=90% Reduction

    Prostate-specific Antigen (PSA) response was defined as 50% and 90% reduction from baseline in serum PSA levels.

    Measured: Day 1 Week 13

  13. Percent Change From Baseline in Serum PSA Concentration

    Measured: Baseline, Day 1 of Week 2, 3 , 5, 9, 13, 17, 21, 25, 29, 33 and 37

  14. PSA Nadir

    Measured: Baseline up to Day 1 Week 25

  15. Serum PSA Concentration

    Measured: Day 1 of Week 13, 25, 29, 33 and 37

  16. Plasma Concentrations of TAK-385

    Measured: Day 1 Week 1, 2, 3, 5, 9, 13, 17, 25, 33, 37: Pre-dose; Day 1 Week 5, 13: 2 hrs Post-dose; Day 4 Week 1: Pre-dose

  17. Serum Luteinizing Hormone (LH) Level

    Measured: Baseline, Day 1 of Weeks 2, 3, 5, 9, 13, 17, 21, 25, 29, and 37

  18. Serum Follicle-Stimulating Hormone (FSH) Level

    Measured: Baseline, Day 1 of Week 2, 5, 13, 25 and 29

  19. Serum Sex Hormone-Binding Globulin (SHBG) Level

    Measured: Baseline, Day 1 of Week 2, 5, 13, 25 and 29

  20. Percent Change From Baseline in Aging Male's Symptoms (AMS) Total Scale Score

    AMS scale is a self-administered questionnaire used to 1) assess symptoms of aging (independent from those that are disease related) between groups of males under different conditions; 2) evaluate the severity of symptoms over time; and 3) measure changes before and after androgen therapy. Each question was answered between none (1) to extremely severe (5) for 17 items from psychological (5 items), somatic (7 items), and sexual (5 items) categories. Total score is sum of all the item scores and range from 17 (minimum) to 85 (maximum), where high score indicated high level of symptoms.

    Measured: Day 1 of Weeks 5, 13, 25, 29, 33 and 37

  21. Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) Score

    EORTC QLQ-C30 included 30 questions comprising 9 multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, nausea/vomiting), single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties) and a global health and QOL scale. Most questions used 4 point scale (1 'Not at all' to 4 'Very much'); 2 questions used 7-point scale (1 'Very poor' to 7 'Excellent'). All domain scores were calculated as an average of item scores and transformed to 0-100 score range where a high score from 0-100 indicates: A high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status/quality of life (QoL) represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problem.

    Measured: Baseline and last post-baseline value up to Week 37

  22. Change From Baseline in 25-item Prostate Cancer-specific Questionnaire Supplement (EORTC QLQ-PR25) Score

    EORTC QLQ-PR25 : EORTC module designed to supplement the QLQ-C30 for any application in prostate cancer. It Consist of 25 questions distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Questions used 4 point scale (1 'Not at all' to 4 'Very much'). All raw domain scores are linearly transformed to a 0-100 scale, with higher scores reflecting either more symptoms (urinary, bowel, hormonal treatment-related symptoms) or higher levels of activity or functioning (sexual).

    Measured: Baseline and last post-baseline value up to Week 37

Timeline

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

  1. First posted12 May 2014 (estimated)
  2. Study startJun 2014
  3. Primary completionDec 2015
  4. Study completionDec 2015

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
103 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02135445
Sponsor's protocol ID
C27003 Merge to Takeda
Other IDs
U1111-1152-9537, 2013-005002-53, 14/LO/1052
Status last verified
Mar 2017
First submitted
8 May 2014
Last updated
13 Apr 2017
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TAK-385 and Degarelix in people with Prostate Cancer, run by Millennium Pharmaceuticals, Inc. at 25 sites in 2 countries.

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 13 inclusion and 22 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 13 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in United States, United Kingdom. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 13 Apr 2017). 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?

Percentage of Participants With Effective Castration Rate Over 25 Weeks (time frame: Day 1 Week 5 up to Day 1 Week 25). 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 NCT02135445.

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 13 Apr 2017.

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