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

NCT02135445 | Completed Phase 2 Results

• 4 other identifiers: C27003 Merge to TakedaU1111-1152-95372013-005002-5314/LO/1052
• Study Type: interventional
• Target: 103
• Locations: 2 countries
• Sites: 25

Brief Summary

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

Conditions

Prostate Cancer

Keywords

Drug therapy

Outcome Measures

Primary Outcomes (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.

  Day 1 Week 5 up to Day 1 Week 25

Secondary Outcomes (22)

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

  Baseline up to Week 29

• Number of Participants With TEAEs Related to Physical Findings

  Baseline up to Week 29

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

  Baseline up to Week 29

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

  Baseline up to Week 29

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

  Baseline up to Week 29

Study Arms (2)

TAK-385

EXPERIMENTAL

TAK-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.

Drug: TAK-385

Degarelix

ACTIVE COMPARATOR

Degarelix 240 mg, injection, subcutaneous, on Day 1, followed by degarelix 80 mg, injection, subcutaneous, once every four weeks, for 24 weeks.

Drug: Degarelix

Interventions

TAK-385 DRUG

TAK-385 tablet

TAK-385

Degarelix DRUG

Degarelix injection

Also known as: Firmagon®

Degarelix

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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);
• 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.

Sponsors & Collaborators

• Millennium Pharmaceuticals, Inc.: lead

Study Sites (25)

Unknown Facility

Birmingham, Alabama, United States

Location

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San Diego, California, United States

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Denver, Colorado, United States

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Bradenton, Florida, United States

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Daytona Beach, Florida, United States

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Fort Lauderdale, Florida, United States

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Fort Myers, Florida, United States

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Plantation, Florida, United States

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Jeffersonville, Indiana, United States

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Wichita, Kansas, United States

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Shreveport, Louisiana, United States

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Omaha, Nebraska, United States

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Syracuse, New York, United States

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Columbus, Ohio, United States

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Eugene, Oregon, United States

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Myrtle Beach, South Carolina, United States

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Dallas, Texas, United States

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San Antonio, Texas, United States

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Virginia Beach, Virginia, United States

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Brighton, East Sussex, United Kingdom

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Manchester, Greater Manchester, United Kingdom

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Unknown Facility

Metropolitan Borough of Wirral, Merseyside, United Kingdom

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Taunton, Somerset, United Kingdom

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Unknown Facility

Sutton, Surrey, United Kingdom

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Unknown Facility

Birmingham, West Midlands, United Kingdom

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

relugolix; acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Medical Director
• Organization: Takeda

trialdisclosures@takeda.com

+1-877-825-3327

Study Officials

• Medical Monitor

  Millennium Pharmaceuticals, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2014
• First Posted: May 12, 2014
• Study Start: June 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 13, 2017
• Results First Posted: April 13, 2017

Record last verified: 2017-03

Locations

GB (6); US (19)