A Phase 2 Study to Evaluate the Safety and Efficacy of TAK-385, Together With a Leuprorelin Observational Cohort, in Participants With Prostate Cancer

NCT02083185 | Completed Phase 2 Results FDA Drug

• 3 other identifiers: C27002U1111-1162-5028172837
• Study Type: interventional
• Target: 136
• Locations: 2 countries
• Sites: 23

Brief Summary

The purpose of this study is to evaluate the efficacy of TAK 385 for achieving and maintaining testosterone suppression (\<50 ng/dL).

Conditions

Prostate Cancer

Keywords

Drug therapy

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Effective Castration Rate Over 24 Weeks

  Effective 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 beginning after 4 weeks of treatment.

  Day 1 of Week 5 to Day 1 of Week 25

Secondary Outcomes (16)

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

  From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks

• Number of Participants With TEAEs Related to Physical Examination

  From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks

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

  From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks

• Number of Participants With TEAES Related to Clinical Laboratory Test Results

  From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks

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

  From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks

Study Arms (3)

Relugolix 80 mg

EXPERIMENTAL

Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 80 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator's discretion.

Drug: Relugolix

Relugolix 120 mg

EXPERIMENTAL

Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 120 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator's discretion.

Drug: Relugolix

Leuprorelin 22.5 mg

ACTIVE COMPARATOR

Leuprorelin 22.5 mg, subcutaneous, injection on Day 1 and every 12 Weeks for up to 4 injections (48 weeks).

Drug: Leuprorelin

Interventions

Relugolix DRUG

Relugolix tablets

Also known as: TAK-835

Relugolix 120 mg; Relugolix 80 mg

Leuprorelin DRUG

Leuprorelin subcutaneous injection

Leuprorelin 22.5 mg

Eligibility Criteria

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

You may qualify if:

• Male participant 18 years or older.
• Histologically or cytologically confirmed diagnosis of prostate adenocarcinoma.
• Candidate for androgen deprivation therapy (ADT) for the management of hormone-sensitive prostate cancer with 1 of the following clinical disease states: 1) advanced localized disease not suitable for primary therapy, 2) evidence of prostate-specific antigen (PSA) biochemical or clinical relapse following primary surgery or radiation therapy of curative intent, or 3) newly diagnosed metastatic disease that is asymptomatic or not threatening to vital organs.
• Appropriate serum testosterone and serum PSA concentration at screening as specified in the protocol.
• A body mass index (BMI) ≥ 18.0 at screening and/or baseline.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at screening and/or baseline.
• Male participants, even if surgically sterilized, who agree to practice effective barrier contraception or agree to practice true abstinence.
• Voluntary written consent must be given 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.
• Suitable venous access for the study-required blood sampling, including pharmacokinetic (PK) and pharmacodynamic (PD) Sampling.

You may not qualify if:

• In participants with advanced, localized M0N1 or M1 disease, the presence of clinically significant symptoms or threat to vital organs requiring immediate gonadotropin-releasing hormone (GnRH) /combined or complete androgen blockade (CAB) therapy, chemotherapy, or radiotherapy.
• Previously received androgen deprivation therapy (ADT) for more than 8 months total duration (if ADT was received for 8 months or less, then that ADT must have been completed at least 2 years prior to screening).
• Visceral metastases (liver or lung).
• Features of the participant's medical condition that may make ADT unnecessary or not indicated.
• Scheduled for additional surgical or (salvage) radiation therapy within 6 months after baseline evaluations.
• History of surgical castration.
• Diagnosis of or treatment for another malignancy within the 2 years before the first dose of study drug, or previously diagnosed with another malignancy and have any 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.
• Abnormal screening and/or baseline laboratory values as specified in the protocol.
• History of any significant cardiac condition within 6 months before receiving the first dose of study drug.
• Electrocardiogram (ECG) abnormalities as specified in the protocol
• Congenital long QT syndrome.
• Current use of Class IA (e.g., quinidine, procainamide) or Class III (e.g., amiodarone, sotalol) antiarrhythmic medications.
• Uncontrolled hypertension despite appropriate medical therapy. Participants may be re-screened after referral and further management of hypertension.
• 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).
• Treatment with any investigational products within 3 months before the first dose of study drug.

Sponsors & Collaborators

• Millennium Pharmaceuticals, Inc.: lead

Study Sites (23)

Unknown Facility

Birmingham, Alabama, United States

Location

Unknown Facility

San Diego, California, United States

Location

Unknown Facility

Denver, Colorado, United States

Location

Unknown Facility

Daytona Beach, Florida, United States

Location

Unknown Facility

Jeffersonville, Indiana, United States

Location

Unknown Facility

Wichita, Kansas, United States

Location

Unknown Facility

Shreveport, Louisiana, United States

Location

Unknown Facility

Omaha, Nebraska, United States

Location

Unknown Facility

Lawrenceville, New Jersey, United States

Location

Unknown Facility

Garden City, New York, United States

Location

Unknown Facility

Syracuse, New York, United States

Location

Unknown Facility

Cincinnati, Ohio, United States

Location

Unknown Facility

Springfield, Oregon, United States

Location

Unknown Facility

Lancaster, Pennsylvania, United States

Location

Unknown Facility

Myrtle Beach, South Carolina, United States

Location

Unknown Facility

Nashville, Tennessee, United States

Location

Unknown Facility

Dallas, Texas, United States

Location

Unknown Facility

San Antonio, Texas, United States

Location

Unknown Facility

Virginia Beach, Virginia, United States

Location

Unknown Facility

Abbotsford, British Columbia, Canada

Location

Unknown Facility

Vancouver, British Columbia, Canada

Location

Unknown Facility

Montreal, Quebec, Canada

Location

Unknown Facility

Québec, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

relugolix; Leuprolide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

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: March 6, 2014
• First Posted: March 11, 2014
• Study Start: March 26, 2014
• Primary Completion: January 1, 2016
• Study Completion: February 23, 2017
• Last Updated: May 9, 2018
• Results First Posted: May 9, 2018

Record last verified: 2018-04

Locations

US (19); CA (4)