Dienstag, 23. April 2019
Navigation öffnen
Anzeige:

JOURNAL ONKOLOGIE – STUDIE

Phase 3 Study of BGB-A317 Versus Sorafenib in Patients With Unresectable HCC

Rekrutierend

NCT-Nummer:
NCT03412773

Studienbeginn:
Dezember 2017

Letztes Update:
20.12.2018

Wirkstoff:
BGB-A317, Sorafenib

Indikation (Clinical Trials):
Carcinoma, Carcinoma, Hepatocellular

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
BeiGene

Collaborator:
-

Kontakt

Studienlocations (3 von 96)

Krankenhaus Nordwest gGmbH
Frankfurt/Main
(Hessen)
GermanyRekrutierend» Google-Maps
Maria Gonzalez-Carmona
53105 Bonn
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Stefan Pluntke
45136 Essen
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
St. Jude Heritage Healthcare
92835 Fullerton
United StatesRekrutierend» Google-Maps
Chao Family Comprehensive Cancer Center
92868 Orange
United StatesRekrutierend» Google-Maps
Ingalls Memorial Hospital
60426 Harvey
United StatesRekrutierend» Google-Maps
Healthcare Research Network III, LLC
60487 Tinley Park
United StatesRekrutierend» Google-Maps
Massachusetts General Hospital Cancer Center
02114 Boston
United StatesRekrutierend» Google-Maps
White Plains Hospital Center for Cancer Care - Oncology
10601 White Plains
United StatesAktiv, nicht rekrutierend» Google-Maps
Precision Cancer Research / Dayton Physicians Network
45409 Kettering
United StatesRekrutierend» Google-Maps
The Mays Cancer Center
78229 San Antonio
United StatesRekrutierend» Google-Maps
The First Affiliated Hospital of Bengbu Medical College
233004 Bengbu
ChinaRekrutierend» Google-Maps
The First Affiliated Hospital Of Anhui Medical University
230022 Hefei
ChinaRekrutierend» Google-Maps
Anhui Medical University - The Second Hospital
230601 Hefei
ChinaRekrutierend» Google-Maps
Beijing YouAn Hospital, Capital Medical University
Beijing
ChinaRekrutierend» Google-Maps
Cancer Hopital Chinese Academy of Medical Sciences
Beijing
ChinaRekrutierend» Google-Maps
Fujian Medical University Union Hospital
350001 Fuzhou
ChinaRekrutierend» Google-Maps
Fujian Provincial Cancer Hospital
350014 Fuzhou
ChinaRekrutierend» Google-Maps
Sun Yat-sen Memorial Hospital , Sun Yat-sen University
Guangzhou
ChinaRekrutierend» Google-Maps
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou
ChinaRekrutierend» Google-Maps
The First Affiliated Hospital of Guangxi Medical University
530021 Nanning
ChinaRekrutierend» Google-Maps
Harbin Medical University Cancer Hospital
150081 Harbin
ChinaRekrutierend» Google-Maps
The First Affiliated Hospital of Soochow University
Suzhou
ChinaRekrutierend» Google-Maps
The Second Affiliated Hospital of Nanchang University
330006 Nanchang
ChinaRekrutierend» Google-Maps
The First Hospital of Jilin University
Changchun
ChinaRekrutierend» Google-Maps
The Affiliated Hospital Of Qingdao University
Qingdao
ChinaRekrutierend» Google-Maps
Shanghai Cancer Hospital of Fudan University
200032 Shanghai
ChinaRekrutierend» Google-Maps
Zhongshan Hospital Fudan University
200032 Shanghai
ChinaRekrutierend» Google-Maps
The First Affiliated Hospital Of XI'AN Jiaotong University
710061 Xian
ChinaRekrutierend» Google-Maps
Sichuan Academy of Medical Science & Sichuan Provincial People's Hospital
610072 Sichuan
ChinaRekrutierend» Google-Maps
Zhongnan Hospital of Wuhan University
430071 Wuhan
ChinaRekrutierend» Google-Maps
The First Affiliated Hospital of Zhejiang University
310003 HangZhou
ChinaRekrutierend» Google-Maps
Sir Run Run Shaw Hospital, Zhejiang University
310016 Hangzhou
ChinaRekrutierend» Google-Maps
Peking Union Medical College Hospital
100730 Beijing
ChinaRekrutierend» Google-Maps
The First Affiliated Hospital of Chongqing Medical University
Chongqing
ChinaRekrutierend» Google-Maps
Tianjin Medical University Cancer Institute and Hospital
300060 Tianjin
ChinaRekrutierend» Google-Maps
IRCCS Saverio De Bellis, AO Gastroenterologia
70013 Castellana Grotte
ItalyRekrutierend» Google-Maps
Ospedale S.Bortolo, AULSS n.6 Vicenza
Vicenza
ItalyRekrutierend» Google-Maps
PO di Cremona, ASST di Cremona - Oncologia - Cremona - Radiology
Cremona
ItalyRekrutierend» Google-Maps
Fujita Health University Hospital
470-1192 Toyoake
JapanRekrutierend» Google-Maps
Ehime Prefectural Central Hospital - Gastroenterology
790-0024 Matsuyama
JapanRekrutierend» Google-Maps
Hokkaido University Hospital - Gastroenterology
060-8648 Sapporo
JapanRekrutierend» Google-Maps
Kanazawa University Hospital
9208641 Kanazawa-shi
JapanRekrutierend» Google-Maps
Yokohama City University Medical Center
232-0024 Yokohama
JapanRekrutierend» Google-Maps
University Hospital, Kyoto Prefectural Univ of Medicine
602-8566 Kyoto-shi
JapanRekrutierend» Google-Maps
Kinki University Hospital, Faculty of Medicine - Hematology & Clinical Oncology
589-8511 Osaka-sayama
JapanRekrutierend» Google-Maps
Sasaki Foundation Kyoundo Hospital
101-0062 Chiyoda-Ku
JapanRekrutierend» Google-Maps
Nihon University Itabashi Hospital - Gastroenterological surgery
173-8610 Itabashi-ku
JapanRekrutierend» Google-Maps
National Center for Global Health and Medicine
162-8655 Shinjuku-ku
JapanRekrutierend» Google-Maps
Kumamoto University Hospital
860-8556 Kumamoto
JapanRekrutierend» Google-Maps
Hyogo College of Medicine Hospital
663-8501 Nishinomiya-shi
JapanRekrutierend» Google-Maps
Osaka International Cancer Institute
541-8567 Osaka
JapanRekrutierend» Google-Maps
Tottori University Hospital
683-8504 Tottori
JapanRekrutierend» Google-Maps
Wakayama Medical University
641-8509 Wakayama-shi
JapanRekrutierend» Google-Maps
Osaka City University Hospital
545-8586 Osaka
JapanRekrutierend» Google-Maps
Institut Catalá d´Oncología (I.C.O.)
Hospitalet de Llobregat
SpainRekrutierend» Google-Maps
Hospital Universitario Vall d'Hebrón
8035 Barcelona
SpainRekrutierend» Google-Maps
Hospital Universitari i Politecnic La Fe
Valencia
SpainRekrutierend» Google-Maps
Chang Gung Medical Foundation - Kaohsiung Chang Gung Memorial Hospital - Gastroenterology
Kaohsiung
TaiwanRekrutierend» Google-Maps
Kaohsiung Medical University - Chung-Ho Memorial Hospital
Kaohsiung
TaiwanRekrutierend» Google-Maps
Tri-Service General Hospital - Neihu Branch
New Taipei
TaiwanRekrutierend» Google-Maps
China Medical University Hospital - Transplantology - Taichung
Taichung
TaiwanRekrutierend» Google-Maps
Taichung Veterans General Hospital
Taichung
TaiwanRekrutierend» Google-Maps
National Cheng Kung University Hospital
705 Tainan
TaiwanRekrutierend» Google-Maps
Taipei Veterans General Hospital
112 Taipei
TaiwanRekrutierend» Google-Maps
Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital
Taipei
TaiwanRekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Brief Summary:

This is a Phase 3, randomized, open-label, multicenter, global study designed to compare the efficacy and safety of BGB-A317 versus sorafenib as a first-line systemic treatment in patients with unresectable hepatocellular carcinoma. This study also includes a substudy investigating the safety, tolerability, PK, and preliminary efficacy in HCC in Japanese patients. In Japan, preliminary safety and tolerability will be evaluated (Safety Run-In Substudy) before Japanese patients are recruited in this Phase 3 study.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- 1. Histologically confirmed diagnosis of HCC

2. Barcelona Clinic Liver Cancer (BCLC) Stage B or C disease not amenable to or progressing after loco-regional therapy and not amenable to a curative treatment approach

3. No prior systemic therapy for HCC (with the exception of HCC patients enrolled in the safety run-in substudy [Japan only])

4. Measurable disease

5. Child-Pugh score A

6. Easter Cooperative Oncology Group (ECOG) Performance Status ≤ 1

7. Adequate organ function

Exclusion Criteria:

- 1. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC histology

2. Tumor thrombus involving main trunk of portal vein or inferior vena cava

3. Loco-regional therapy to the liver within 28 days before randomization

4. Clinical evidence of portal hypertension with bleeding esophageal or gastric varices at Screening, or within 6 months before randomization

5. Bleeding or thrombotic disorder or any prescribed anticoagulant requiring therapeutic international normalized ratio monitoring (eg, warfarin or similar agents) at Screening, or within 6 months before randomization/enrollment

6. Presence at Screening of active immune deficiency or autoimmune disease and/or prior history of any immune deficiency or autoimmune disease that may relapse

7. Patient with any condition requiring systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication within 14 days before randomization

8. History of interstitial lung disease or non-infectious pneumonitis, unless induced by radiation therapy

9. QT interval corrected for heart rate (QTc) (corrected by Fridericia's method) > 450 msec at Screening

Studien-Rationale

Primary outcome:

1. Overall Survival (OS) (Time Frame - From date of randomization up to 4 years, approximately)

2. Safety Run-In Substudy[Japan only]: Percentage of patients with adverse events (Time Frame - From date of enrollment up to 4 years, approximately.)

3. Safety Run-In Substudy[Japan only]: Percentage of patients with dose-limiting toxicities (DLT) [Determination of the pivotal Phase 3 dose of BGB-A317 in Japanese patients] (Time Frame - From the date of enrollment up to 28 days [DLT period].)

4. Safety Run-In Substudy[Japan only]: Maximum Concentration (Cmax) of BGB-A317 (Time Frame - From first dose of study treatment up to 4 years, approximately.)

5. Safety Run-In Substudy[Japan only]: Trough Serum Concentration (Cmin) of BGB-A317 (Time Frame - From first dose of study treatment up to 4 years, approximately.)

6. Safety Run-In Substudy[Japan only]: Area Under the Curve (AUC) of BGB-A317 (Time Frame - From first dose of study treatment up to 4 years, approximately.)

7. Safety Run-In Substudy[Japan only]:Anti-Drug Antibodies (ADA) against BGB-A317 at Cmin (Time Frame - From first dose of study treatment up to 4 years, approximately.)

8. Safety Run-In Substudy[Japan only]: Percentage of Participants With Clinically Significant Changes in Vital Signs Findings (Time Frame - From date of enrollment up to 4 years, approximately.)

9. Safety Run-In Substudy[Japan only]: Percentage of Participants With Clinically Significant Changes in Physical Examination Findings (Time Frame - From date of enrollment up to 4 years, approximately.)

10. Safety Run-In Substudy[Japan only]: Percentage of Participants With Clinically Significant Changes in Clinical Laboratory Results Findings (Time Frame - From date of enrollment up to 4 years, approximately.)

11. Safety Run-In Substudy[Japan only]: Percentage of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Findings (Time Frame - From date of enrollment up to 4 years, approximately.)

Secondary outcome:

1. Objective Response Rate (ORR) (Time Frame - From date of randomization up to 4 years, approximately)

2. Progression-free survival (PFS) (Time Frame - From date of randomization up to 4 years, approximately)

3. Duration of Response (DOR) (Time Frame - From first determination of an objective response up to 4 years, approximately)

4. Time to Progression (TTP) (Time Frame - From date of randomization up to 4 years, approximately.)

5. Health-Related Quality of Life (HRQoL) (Time Frame - From date of enrollment up to 4 years, approximately.)

6. Disease Control Rate (DCR) (Time Frame - From first dose of study treatment up to 4 years, approximately)

7. Clinical Benefit Rate (CBR) (Time Frame - From first dose of study treatment up to 4 years, approximately)

8. Percentage of patients with adverse events (Time Frame - From date of screening up to 4 years, approximately.)

9. Safety Run-In Substudy[Japan only]: Objective Response Rate (ORR) (Time Frame - From date of randomization up to 4 years, approximately.)

10. Safety Run-In Substudy[Japan only]: Progression-free survival (PFS) (Time Frame - From date of randomization up 4 years, approximately)

11. Safety Run-In Substudy[Japan only]: Duration of Response (DOR) (Time Frame - From date of randomization up 4 years, approximately)

12. Safety Run-In Substudy[Japan only]: Overall Survival (OS) (Time Frame - From date of randomization up 4 years, approximately)

13. Safety Run-In Substudy[Japan only]: Anti-BGB-A317 antibody (Time Frame - From first dose of study treatment up 4 years, approximately)

14. Percentage of Participants With Clinically Significant Changes in Vital Signs Findings (Time Frame - From date of enrollment up to 4 years, approximately)

15. Percentage of Participants With Clinically Significant Changes in Physical Examination Findings (Time Frame - From date of enrollment up to 4 years, approximately)

16. Percentage of Participants With Clinically Significant Changes in Clinical Laboratory Results Findings (Time Frame - From date of enrollment up to 4 years, approximately)

17. Percentage of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Findings (Time Frame - From date of enrollment up to 4 years, approximately)

Studien-Arme

  • Experimental: Arm A: BGB-A317 & Safety Run-In Substudy [Japan Only]
  • Active Comparator: Arm B: Sorafenib

Geprüfte Regime

  • BGB-A317 (PD-1 ANTIBODY):
    BGB-A317: 200 mg once every 3 weeks (Q3W), intravenous dosing (IV)
  • Sorafenib (Nexavar, BAY43-9006):
    Sorafenib: 400 mg twice daily (BID), oral dosing

Quelle: ClinicalTrials.gov


Das könnte Sie auch interessieren

40 Jahre Frauenselbsthilfe nach Krebs

40 Jahre Frauenselbsthilfe nach Krebs
© kuznetsov_konsta / Fotolia.com

Am 26. August 2016 begeht die Frauenselbsthilfe nach Krebs (FSH) im Rahmen ihrer Bundestagung ihr 40-jähriges Jubiläum. Als einer der größten und ältesten Krebs-Selbsthilfeverbände Deutschlands leistet sie unverzichtbare Hilfe für Betroffene und beeinflusst aktiv politische Entscheidungsprozesse im Gesundheitswesen. Dort tritt sie für die Bedürfnisse von Betroffenen ein – dass Patienten heute wesentlich mehr Recht auf Mitsprache...

Urologen starten Themenwoche Hodenkrebs vom 27. bis 31. März 2017

Urologen starten Themenwoche Hodenkrebs vom 27. bis 31. März 2017
© Paolese / Fotolia.com

Deutschlands Urologen gehen neue Wege in der Öffentlichkeitsarbeit: Mit der Einführung der „Urologischen Themenwochen“ baut die Deutsche Gesellschaft für Urologie e.V. (DGU) ihr Engagement in der medizinischen Aufklärung der Bevölkerung erneut aus: Den Anfang macht die Urologische Themenwoche Hodenkrebs vom 27. bis 31. März 2017. Mit zielgruppengerecht aufbereiteten Informationen wollen Urologinnen und Urologen männliche Heranwachsende und junge...

Kostenlose Kosmetikseminare “look good feel better“ für Krebspatientinnen

Kostenlose Kosmetikseminare “look good feel better“ für Krebspatientinnen
© Carolin Lauer (carolinlauer.de)

Ganz unverhofft trifft die damals 30jährige Cristina aus Hannover die Diagnose Krebs. Erst dachte sie an einen schlechten Scherz, als sie den Anruf von ihrem Arzt erhielt und dann zog ihr die Nachricht den Boden unter den Füßen weg. Mit der Chemotherapie kamen der Verlust der Haare, Augenbrauen und Wimpern und damit auch teilweise unangenehme Situationen: „Selbst als ich noch Stoppeln auf dem Kopf hatte, haben mich sofort alle angestarrt. Teilweise getuschelt oder den...

Vor der Darmspiegelung ist „Abführen an zwei Tagen“ am effektivsten

Vor der Darmspiegelung ist „Abführen an zwei Tagen“ am effektivsten
© Sebastian Kaulitzki / Fotolia.com

Je sauberer der Darm, umso aussagekräftiger ist das Ergebnis einer Darmspiegelung zur Krebsvorsorge. Darauf weisen Experten im Vorfeld des Kongresses Viszeralmedizin 2016 in Hamburg hin. Um den Darm optimal für die „Koloskopie“ vorzubereiten, sollten Patienten auf zwei Tage verteilt eine Poly-Ethylen-Glykol-Lösung (kurz: PEG) als Abführmittel zu sich nehmen, so die Mediziner. Die Darmspiegelung gilt als eines der effektivsten Verfahren der Krebsvorsorge...