RECRUITING

Study to Continue Treatment With Darolutamide in Patients Who Have Been Participating in Previous Darolutamide Studies Supported by Bayer

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Conditions

CancerRoll-Over Study

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The aim of this study is to provide darolutamide treatment to patients who participated in a previous study with darolutamide supported by Bayer and the treating doctor considers that the continuation of the treatment with darolutamide to be beneficial. Patients will be carried over from the previous studies and continue in this study with darolutamide treatment on the same dosage. They will also return to the study centers for doctor's visits as often as they did in the previous study.

Official Title

An Open-label, Single Arm, Roll-over Study to Provide Continued Treatment With Darolutamide in Participants Who Were Enrolled in Previous Bayer Sponsored Studies

Quick Facts

Study Start:2020-10-20
Study Completion:2028-06-26
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04464226

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
  2. * Participants enrolled in any Bayer-sponsored darolutamide feeder study at the time of study closure or primary completion, who are currently receiving darolutamide and are experiencing clinical benefit from treatment.
  3. * Participants who have not met any treatment discontinuation criteria in the feeder study protocol.
  4. * Willingness to continue practicing acceptable methods of birth control during the study.
  1. * Participant is unable to comply with the requirements of the study.
  2. * Negative benefit/ risk ratio as determined by the investigator.
  3. * Meet any criteria for treatment discontinuation of the feeder study the participant is coming from.

Contacts and Locations

Study Contact

Bayer Clinical Trials Contact
CONTACT
(+)1-888-84 22937
clinical-trials-contact@bayer.com

Study Locations (Sites)

Urology Centers of Alabama, PC
Homewood, Alabama, 35209
United States
Ironwood Physicians P.C. DBA Ironwood Cancer & Res. Ctr.
Chandler, Arizona, 85224
United States
City of Hope National Medical Center
Duarte, California, 91010
United States
San Diego Clinical Trials
La Mesa, California, 91942
United States
Tower Urology, Inc
Los Angeles, California, 90048
United States
VA Greater Los Angeles Healthcare System
Los Angeles, California, 90073-1003
United States
Stanford Health Care
Stanford, California, 94305
United States
TOI Clinical Research
Whittier, California, 90603
United States
VA Eastern Colorado Health Care System
Aurora, Colorado, 80045
United States
The Urology Center Of Colorado
Denver, Colorado, 80211
United States
Boca Raton Regional Hospital
Boca Raton, Florida, 33486
United States
Advent Health Medical Group Urology
Orlando, Florida, 32803
United States
Jesse Brown VA Medical Center
Chicago, Illinois, 60612
United States
Illinois CancerCare, PC
Peoria, Illinois, 61615-7828
United States
First Urology PSC
Jeffersonville, Indiana, 47130
United States
Norton Healthcare Pavilion
Louisville, Kentucky, 40202
United States
Anne Arundel Health System
Annapolis, Maryland, 21401
United States
Chesapeake Urology Associates
Baltimore, Maryland, 21204
United States
Johns Hopkins Hospital/Health System
Baltimore, Maryland, 21287
United States
TidalHealth Peninsula Regional, Inc.
Salisbury, Maryland, 21801
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114-2696
United States
Henry Ford Health System
Detroit, Michigan, 48202
United States
St. Vincent Hospital & Healthcare
Billings, Montana, 59102
United States
Urology Cancer Center, PC
Omaha, Nebraska, 68130-5606
United States
GU Research Network, LLC
Omaha, Nebraska, 68130
United States
New Jersey Urology, LLC
Voorhees, New Jersey, 08043
United States
New Mexico Oncology Hematology Consultants, Ltd.
Albuquerque, New Mexico, 87109
United States
Montefiore Medical Center
Bronx, New York, 10467-2490
United States
New York Cancer & Blood Specialists
Bronx, New York, 10469
United States
University of Rochester Medical Center
Rochester, New York, 14642
United States
Associated Medical Professionals of NY, PLLC
Syracuse, New York, 13210
United States
Gabrail Cancer Center
Canton, Ohio, 44718
United States
The Urology Group
Cincinnati, Ohio, 45212
United States
Ohio State University
Columbus, Ohio, 43210
United States
MidLantic Urology - Bala Cynwyd
Bala-Cynwyd, Pennsylvania, 19004
United States
Andrews & Patel Associates
Camp Hill, Pennsylvania, 17011
United States
Charleston Oncology - Downtown
Charleston, South Carolina, 29403
United States
Bon Secours St. Francis Hospital
Greenville, South Carolina, 29607
United States
Carolina Urological Research Center
Myrtle Beach, South Carolina, 29579
United States
Urology Associates, PC
Nashville, Tennessee, 37209
United States
Urology Clinics of North Texas
Dallas, Texas, 75231
United States
Huntsman Cancer Institute- Salt Lake City
Salt Lake City, Utah, 84112
United States
Inova Fairfax Hospital - Falls Church
Falls Church, Virginia, 22042
United States
Virginia Commonwealth University
Richmond, Virginia, 23284
United States
Providence Regional Cancer Partnership
Everett, Washington, 98201
United States

Collaborators and Investigators

Sponsor: Bayer

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-10-20
Study Completion Date2028-06-26

Study Record Updates

Study Start Date2020-10-20
Study Completion Date2028-06-26

Terms related to this study

Keywords Provided by Researchers

  • Roll-Over Study

Additional Relevant MeSH Terms

  • Cancer