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Clinical Trials in China / NCT02960022
Active, not recruiting Phase 2

A Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study

NCT02960022 · tracked via the Priya Life Science China tracker
Sponsor
Astellas Pharma Global Development, Inc.
Phase
Phase 2
Started
2016-12-22
Last updated
2026-09-11

Condition(s) studied

Prostate Cancer

Investigational drug(s) / intervention(s)

enzalutamideabiraterone acetateprednisoneLeuprolide acetate

enzalutamide: Subjects will receive enzalutamide orally once daily at the same time each day.

abiraterone acetate: Subjects enrolling from study 9785-CL-0011 or MDV3100-10 (PLATO) study may receive abiraterone acetate once daily and prednisone twice daily, in addition to enzalutamide

prednisone: Subjects enrolling from study 9785-CL-0011 or MDV3100-10 (PLATO) study may receive abiraterone acetate once daily and prednisone twice daily, in addition to enzalutamide

Leuprolide acetate: Subjects enrolling from study MDV3100-13 (EMBARK) study may receive leuprolide acetate once every 12 weeks in addition to enzalutamide once daily

Study summary

The purpose of this study is to collect long term safety data in subjects who are continuing to derive clinical benefit from treatment with Enzalutamide from the subjects participation in an enzalutamide clinical study sponsored by Astellas or Medivation (i.e., parent study) which has completed, at a minimum, the primary analysis or the study specified evaluation period.

Eligibility

Sex
MALE
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Subject must currently be receiving enzalutamide or assigned to receive enzalutamide (if on treatment suspension) for prostate cancer in a study sponsored by Astellas or Medivation and, based on the investigator's assessment, benefit from continued treatment. Subjects participating in investigator-initiated trials are not eligible. * Subject is able to continue on the treatment regimen that they were receiving or were assigned to receive in the prior study. If in the investigator's assessment, a change is needed to the subject's regimen (e.g., dose change in Androgen deprivation therapy (ADT) or dropping of a combination therapy) approval from a medical monitor is required prior to enrollment. * Subject is able to swallow enzalutamide capsules and comply with study requirements. * Subject and female partner who is of childbearing potential must continue to use 2 forms of birth control, of which 1 must be highly effective and 1 must be a barrier method throughout the study and for 3 months after final enzalutamide administration. * Subject agrees to avoid sperm donation during the study and for at least 3 months after final enzalutamide administration. * Subject agrees not to participate in another interventional study while on treatment. Canada Specific: * Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent and privacy language as per national regulations (e.g., Health Insurance Portability and Accountability Act authorization for the United States sites) must be obtained from the subject prior to any study-related procedures. * Subject must currently be receiving enzalutamide for breast cancer in a study sponsored by Astellas or Medivation/Pfizer and based on the investigator's assessment, benefit from continued treatment. Subjects participating in investigator-initiated trials are not eligible. * Subject is able to continue on the treatment regimen that they were receiving in the prior study. If in the investigator's assessment, a change is needed to the subject's regimen (e.g., dropping of a combination therapy) approval from a medical monitor is required prior to enrollment. * Subject is able to swallow enzalutamide capsules and comply with study requirements. * Subject is either: * Of nonchildbearing potential: * postmenopausal (defined as no spontaneous menses for at least 12 months prior to Day 1 with follicle stimulating hormone (FSH) \> 40 IU/L at Day 1 for women \< 55 years of age), * documented surgically sterile or status post hysterectomy (at least 1 month prior to Day 1), * Or, if of childbearing potential, * must have a negative urine pregnancy test at Day 1 before the first dose of study drug is administered, * must use 2 acceptable methods of birth control starting at Day 1 and through 6 months after the final study drug administration, * must not donate ova starting at first administration of study intervention and throughout 6 months after final study intervention administration. The 2 acceptable methods of birth control are as follows or per local guidelines where these require additional description of contraceptive methods: * A barrier method (e.g., condom by a male partner) is required; AND * One of the following is required: * Placement of an intrauterine device (IUD) or intrauterine system (IUS); * Additional barrier method including occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository; * Vasectomy or other surgical castration at least 6 months before Day 1. * The subject must not be breastfeeding at Day 1 or during the study period, and for 6 months after the final study drug administration. * Subject agrees not to participate in another interventional study while on treatment. Exclusion Criteria: * Subject met any of the discontinuation criteria or whose cancer progressed on the current enzalutamide clinical study in which subject is enrolling from. * Subject requires treatment with or plans to use either of the following: * New systemic therapy for subjects cancer (palliative radiation therapy is allowed). The treatment with agents administered during previous studies which was stopped and then restarted during this study does not represent new treatment. * Investigational therapy other than enzalutamide. * Subject is currently participating in an investigator-initiated interventional trial and receiving enzalutamide. * Subject has any concurrent disease, infection, or comorbid condition that interferes with the ability of the subject to participate in the study, which places the subject at undue risk or complicates the interpretation of data. Canada Specific: Subject will be excluded from participation if any of the following apply: * Subject met any of the discontinuation criteria or whose cancer progressed on the current enzalutamide clinical study in which they are enrolling from. * Subject requires treatment with or plans to use any of the following: * New systemic therapy for their cancer (palliative radiation therapy is allowed). The treatment with agents administered during previous studies which was stopped and then restarted during this study does not represent new treatment. * Investigational therapy other than enzalutamide. * Subject is currently participating in an investigator-initiated interventional trial and receiving enzalutamide. * Subject has any concurrent disease, infection, or comorbid condition that interferes with the ability of the subject to participate in the study, which places the subject at undue risk or complicates the interpretation of data in the opinion of the investigator.

Primary outcome measure(s)

Trial sites (234)

FacilityCityRegionStatus
Site US10052 Anchorage Alaska
Site US10011 Tucson Arizona
Site US10040 Los Angeles California
Site US10009 Los Angeles California
Site US10008 San Bernardino California
Site US10042 San Diego California
Site US10028 Stanford California
Site US10001 Aurora Colorado
Site US10017 Denver Colorado
Site US10050 Washington D.C. District of Columbia
Site US10049 Daytona Beach Florida
Site US10002 Chicago Illinois
Springfield Clinic, LLP Springfield Illinois
Site US10007 Jeffersonville Indiana
University of Kansas Medical Center Kansas City Kansas
Site US10066 Lenexa Kansas
Site US10029 Towson Maryland
Site US10032 St Louis Missouri
Nebraska Medical Hospital Omaha Nebraska
Site US10023 Omaha Nebraska
Site US10004 Hackensack New Jersey
Site US10024 Garden City New York
Site US10055 New York New York
Site US10059 New York New York
Hudson Valley Urology, PC Poughkeepsie New York
Site US10053 Syracuse New York
Site US10030 Chapel Hill North Carolina
Site US10062 Charlotte North Carolina
Site US10031 Greensboro North Carolina
Eastern Urological Associates Greenville North Carolina
Site US10046 Winston-Salem North Carolina
Site US10035 Cincinnati Ohio
Site US10022 Springfield Oregon
Site US10027 Lancaster Pennsylvania
Site US10005 Pittsburgh Pennsylvania
Site US10018 Charleston South Carolina
Carolina Urologic Research Center Myrtle Beach South Carolina
Site US10041 Nashville Tennessee
Site US10010 Dallas Texas
Site US10034 Houston Texas

+ 194 more sites — see the full list on the official registry below.

On this site

📄 Xtandi (enzalutamide) drug profile → 📄 Deltasone (prednisone) drug profile →

More Astellas Pharma Global Development, Inc. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02960022 on ClinicalTrials.gov ↗ ← All trials in China