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JOURNAL ONKOLOGIE – STUDIE

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

Rekrutierend

NCT-Nummer:
NCT02960022

Studienbeginn:
Dezember 2016

Letztes Update:
25.03.2024

Wirkstoff:
Enzalutamide, abiraterone acetate, Prednisone

Indikation (Clinical Trials):
Prostatic Neoplasms

Geschlecht:
Männer

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 2

Sponsor:
Astellas Pharma Global Development, Inc.

Collaborator:
Pfizer

Studienleiter

Associate Medical Director
Study Director
Astellas Pharma Global Development, Inc.

Kontakt

Astellas Pharma Global Development
Kontakt:
Phone: 800-888-7704
E-Mail: astellas.registration@astellas.com» Kontaktdaten anzeigen

Studienlocations
(3 von 221)

Site DE49004
72622 Nürtingen
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Site DE49007
79761 Waldshut-Tiengen
(Baden-Württemberg)
GermanyAbgeschlossen» Google-Maps
Site DE49006
68167 Mannheim
(Baden-Württemberg)
GermanyAktiv, nicht rekrutierend» Google-Maps
Site DE49001
47179 Duisburg
(Nordrhein-Westfalen)
GermanyAbgeschlossen» Google-Maps
Site DE49010
53111 Bonn
(Nordrhein-Westfalen)
GermanyAktiv, nicht rekrutierend» Google-Maps
Site DE49003
22081 Hamburg
(Hamburg)
GermanyAktiv, nicht rekrutierend» Google-Maps
Site US10011
85741 Tucson
United StatesAktiv, nicht rekrutierend» Google-Maps
Site US10040
90024 Los Angeles
United StatesAktiv, nicht rekrutierend» Google-Maps
Site US10042
92108 San Diego
United StatesAktiv, nicht rekrutierend» Google-Maps
Site US10001
80045 Aurora
United StatesAktiv, nicht rekrutierend» Google-Maps
Site US10002
60637 Chicago
United StatesAktiv, nicht rekrutierend» Google-Maps
Springfield Clinic, LLP
62701 Springfield
United StatesRekrutierend» Google-Maps
University of Kansas Medical Center
66160 Kansas City
United StatesRekrutierend» Google-Maps
Nebraska Medical Hospital
68114 Omaha
United StatesRekrutierend» Google-Maps
Site US10023
68130 Omaha
United StatesAktiv, nicht rekrutierend» Google-Maps
Site US10004
07601 Hackensack
United StatesAktiv, nicht rekrutierend» Google-Maps
Site US10024
11530 Garden City
United StatesAktiv, nicht rekrutierend» Google-Maps
Site US10059
10065 New York
United StatesAktiv, nicht rekrutierend» Google-Maps
Hudson Valley Urology, PC
12601 Poughkeepsie
United StatesRekrutierend» Google-Maps
Site US10062
28207 Charlotte
United StatesAktiv, nicht rekrutierend» Google-Maps
Eastern Urological Associates
27834 Greenville
United StatesRekrutierend» Google-Maps
Site US10027
17604 Lancaster
United StatesAktiv, nicht rekrutierend» Google-Maps
Site US10005
15232 Pittsburgh
United StatesAktiv, nicht rekrutierend» Google-Maps
Site US10018
29414 Charleston
United StatesAktiv, nicht rekrutierend» Google-Maps
Carolina Urologic Research Center
29572 Myrtle Beach
United StatesRekrutierend» Google-Maps
Site US10010
75231 Dallas
United StatesAktiv, nicht rekrutierend» Google-Maps
Site US10043
77030 Houston
United StatesAktiv, nicht rekrutierend» Google-Maps
Site US10015
23462 Virginia Beach
United StatesAktiv, nicht rekrutierend» Google-Maps
Virginia Mason Medical Center
98101 Seattle
United StatesRekrutierend» Google-Maps
Site US10038
98109 Seattle
United StatesAktiv, nicht rekrutierend» Google-Maps
Site US10021
53792 Madison
United StatesAktiv, nicht rekrutierend» Google-Maps
Site AR54006
T4000IAK San Miguel de Tucuman
ArgentinaRekrutierend» Google-Maps
Site FR33002
69003 Lyon Cedex 3
FranceAktiv, nicht rekrutierend» Google-Maps
Toho University Sakura Medical Center
Sakura-shi
JapanAktiv, nicht rekrutierend» Google-Maps
Gunma University Hospital
Maebashi-shi
JapanAktiv, nicht rekrutierend» Google-Maps
Yokohama City University Medical Center
232-0024 Yokohama
JapanAktiv, nicht rekrutierend» Google-Maps
Kindai University Hospital
589-8511 Sayama
JapanAktiv, nicht rekrutierend» Google-Maps
Nippon Medical School Hospital
Bunkyo-ku
JapanAktiv, nicht rekrutierend» Google-Maps
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Koutou-ku
JapanAbgeschlossen» Google-Maps
Yamaguchi University Hospital
Ube
JapanAktiv, nicht rekrutierend» Google-Maps
Chiba cancer center
260-8717 Chiba
JapanAktiv, nicht rekrutierend» Google-Maps
Harasanshin hospital
812-0033 Fukuoka
JapanAktiv, nicht rekrutierend» Google-Maps
Kyoto University hospital
606-8507 Kyoto
JapanAktiv, nicht rekrutierend» Google-Maps
Niigata University Medical and Dental Hospital
951-8520 Niigata
JapanAktiv, nicht rekrutierend» Google-Maps
Osaka Metropolitan University Hospital
Osaka
JapanAktiv, nicht rekrutierend» Google-Maps
Site KR82012
013620 Seongnam-si
Korea, Republic ofRekrutierend» Google-Maps
Site RU70003
St. Petersburg
Russian FederationAktiv, nicht rekrutierend» Google-Maps
Site GB44009
Bebington
United KingdomAktiv, nicht rekrutierend» Google-Maps
Site GB44005
CF4 4XN Cardiff
United KingdomAktiv, nicht rekrutierend» Google-Maps
Site GB44007
M20 4BX Manchester
United KingdomAktiv, nicht rekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Detailed Description:

Subjects must continue on the treatment regimen that the subject was receiving in the prior

study. Dose changes of any of the prior therapies subjects were receiving on the previous

protocol are allowed after medical monitor approval. The day 1 visit for this study should

coincide with the last treatment visit for the study the subject will be enrolling from (≤ 7

days post last visit of parent study). The subjects will be followed according to the local

institution's standard of care and will be required to return to the institution every 24

weeks (± 7 days) to review adverse events (AEs), collect concomitant medications and confirm

that no discontinuation criteria are met. At each visit and at every 12 weeks (IP only visit)

subjects are to return all dispensed study drug and to receive more study drug if applicable.

All AEs (new and ongoing from the study the subject is enrolling from) and Serious Adverse

Events (SAEs) (including death), will be collected from the time the subject signs the

consent form until the end of study visit.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Subject must currently be receiving enzalutamide 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 the subject was receiving 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.

Studien-Rationale

Primary outcome:

1. Number of participants with adverse events (Time Frame - Until End of Study (Up to 96 Months))

Studien-Arme

  • Experimental: enzalutamide
    Subjects will receive enzalutamide orally once daily at the same time each day
  • Experimental: enzalutamide plus abiraterone acetate and 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 once daily

Geprüfte Regime

  • enzalutamide (MDV3100 / Xtandi / ):
    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

Quelle: ClinicalTrials.gov


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