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JOURNAL ONKOLOGIE – STUDIE

Tumor-Agnostic Precision Immuno-Oncology and Somatic Targeting Rational for You (TAPISTRY) Platform Study

Rekrutierend

NCT-Nummer:
NCT04589845

Studienbeginn:
Januar 2021

Letztes Update:
08.04.2021

Wirkstoff:
Entrectinib, Alectinib, Atezolizumab, Ipatasertib, Trastuzumab Emtansine, Idasanutlin, Inavolisib, Belvarafenib, Pralsetinib

Geschlecht:
Alle

Altersgruppe:
Alle

Phase:
Phase 2

Sponsor:
Hoffmann-La Roche

Collaborator:
-

Studienleiter

Clinical Trials
Study Director
Hoffmann-La Roche

Kontakt

Reference Study ID Number: BO41932 www.roche.com/about_roche/roche_worldwide.htm
Kontakt:
Phone: 888-662-6728 (U.S. and Canada)
E-Mail: Global-Roche-Genentech-Trials@gene.com
» Kontaktdaten anzeigen

Studienlocations
(3 von 147)

Uniklinik Essen
45122 Essen
(Nordrhein-Westfalen)
GermanyNoch nicht rekrutierend» Google-Maps
Universitätsklinikum Freiburg Medizinische Klinik Innere Medizin I
79106 Freiburg
(Baden-Württemberg)
GermanyNoch nicht rekrutierend» Google-Maps
Georg-August-Uniklinik ; Zentrum Innere Medizin Abt. Hämatologie & Onkologie
37075 Göttingen
(Niedersachsen)
GermanyNoch nicht rekrutierend» Google-Maps
Universitätsklinikum Hamburg-Eppendorf Onkologisches Zentrum Medizinische Klinik II
20246 Hamburg
(Hamburg)
GermanyNoch nicht rekrutierend» Google-Maps
Medizinische Hochschule Zentrum Innere Medizin Abt.Gastroenterologie, Endokrinologie und Hepatologie
30625 Hannover
(Niedersachsen)
GermanyNoch nicht rekrutierend» Google-Maps
Klinik Kinderheikunde I des Zentrums für Kinder- und Jugendmedizin, Universität Heidelberg
69120 Heidelberg
(Baden-Württemberg)
GermanyNoch nicht rekrutierend» Google-Maps
SLK-Kliniken Heilbronn GmbH; Klinik für Innere Medizin III; Schwerpunkt Häma./Onko./Palliativm.
74078 Heilbronn
(Baden-Württemberg)
GermanyNoch nicht rekrutierend» Google-Maps
Praxis für Hämatologie, Onkologie und Palliativmedizin
41066 Mönchengladbach
(Nordrhein-Westfalen)
GermanyNoch nicht rekrutierend» Google-Maps
Klinikum der Universität München, Campus Großhadern; Medizinische Klinik und Poliklinik III
81377 München
(Bayern)
GermanyNoch nicht rekrutierend» Google-Maps
Uniklinikum, Comprehensive Cancer Center Mainfranken; Interdisziplinäres Studienzentrum mit ECTU
97078 Würzburg
(Bayern)
GermanyNoch nicht rekrutierend» Google-Maps
Western Regional Medical Center at Cancer Treatment Centers of America
85338 Goodyear
United StatesRekrutierend» Google-Maps
City of Hope National Medical Center
91010 Duarte
United StatesRekrutierend» Google-Maps
Kaiser Permanente Los Angeles
90027 Los Angeles
United StatesRekrutierend» Google-Maps
USC Norris Cancer Center
90033 Los Angeles
United StatesNoch nicht rekrutierend» Google-Maps
UC Davis Comprehensive Cancer Center
95817 Sacramento
United StatesRekrutierend» Google-Maps
University of California at San Francisco
94115 San Francisco
United StatesNoch nicht rekrutierend» Google-Maps
Sarcoma Oncology Center
90403 Santa Monica
United StatesRekrutierend» Google-Maps
Children's Hospital Colorado; Center For Cancer/Blood Disorder
80045 Aurora
United StatesNoch nicht rekrutierend» Google-Maps
Christiana Care Health Srvcs; Helen F Graham Can Center
19713 Newark
United StatesRekrutierend» Google-Maps
University of Florida
32607 Gainesville
United StatesRekrutierend» Google-Maps
Miami Cancer Institute of Baptist Health, Inc.
33176 Miami
United StatesNoch nicht rekrutierend» Google-Maps
University Cancer & Blood Center, LLC; Research
30607 Athens
United StatesNoch nicht rekrutierend» Google-Maps
St. Alphonsus
83706 Boise
United StatesNoch nicht rekrutierend» Google-Maps
Midwestern Regional Med Center
60099 Zion
United StatesRekrutierend» Google-Maps
Horizon Oncology Research, Inc.
47905 Lafayette
United StatesRekrutierend» Google-Maps
New England Cancer Specialists
04074 Scarborough
United StatesNoch nicht rekrutierend» Google-Maps
Saint Joseph Mercy Ann Arbor Hospital
48106 Ann Arbor
United StatesNoch nicht rekrutierend» Google-Maps
Henry Ford Health System
48202 Detroit
United StatesRekrutierend» Google-Maps
University of Minnesota
55455 Minneapolis
United StatesNoch nicht rekrutierend» Google-Maps
Washington University
63128 Saint Louis
United StatesRekrutierend» Google-Maps
Comprehensive Cancer Centers of Nevada - Eastern Avenue
89169 Las Vegas
United StatesRekrutierend» Google-Maps
Dartmouth Hitchcock Medical Center
03756 Lebanon
United StatesNoch nicht rekrutierend» Google-Maps
Rutgers Cancer Institute of New Jersey
08901 New Brunswick
United StatesRekrutierend» Google-Maps
University of New Mexico; Comprehensive Cancer Center
87131 Albuquerque
United StatesRekrutierend» Google-Maps
University of New Mexico Comprehensive Cancer Center - South Telshore Blvd; Drug Supplies
88011 Las Cruces
United StatesRekrutierend» Google-Maps
Montefiore Einstein Center for Cancer Care
10461 Bronx
United StatesRekrutierend» Google-Maps
Eastchester Center for Cancer Care
10469 Bronx
United StatesRekrutierend» Google-Maps
Memorial Sloan-Kettering Cancer Center
11725 Commack
United StatesNoch nicht rekrutierend» Google-Maps
New York Cancer and Blood Specialists - Setauket Medical Oncology
11733 East Setauket
United StatesRekrutierend» Google-Maps
National Translational Research Group
10028 New York
United StatesRekrutierend» Google-Maps
Icahn School of Medicine at Mount Sinai
10029 New York
United StatesNoch nicht rekrutierend» Google-Maps
Levine Cancer Institute
28204 Charlotte
United StatesNoch nicht rekrutierend» Google-Maps
Barrett Cancer Center
45219 Cincinnati
United StatesRekrutierend» Google-Maps
Oncology Hematology Care Inc
45242 Cincinnati
United StatesRekrutierend» Google-Maps
Providence Portland Medical Center
97213 Portland
United StatesNoch nicht rekrutierend» Google-Maps
Consultants in Medical Oncology and Hematology
19008 Broomall
United StatesRekrutierend» Google-Maps
Virginia Cancer Specialists - Leesburg
20176 Leesburg
United StatesRekrutierend» Google-Maps
The Children's Hospital of Philadelphia
19104 Philadelphia
United StatesNoch nicht rekrutierend» Google-Maps
Cancer Treatment Centers of America; Eastern Regional Medical Center
19124 Philadelphia
United StatesRekrutierend» Google-Maps
Prisma Health Cancer Institute; Research Pharmacy
29605 Greenville
United StatesNoch nicht rekrutierend» Google-Maps
The West Clinic; West Cancer Center
38138 Germantown
United StatesRekrutierend» Google-Maps
St. Jude Children'S Research Hospital
38105 Memphis
United StatesNoch nicht rekrutierend» Google-Maps
Texas Onc-Central Austin CA Ct
78731 Austin
United StatesRekrutierend» Google-Maps
Mary Crowley Medical Research Center
75230 Dallas
United StatesRekrutierend» Google-Maps
Texas Oncology - Baylor Charles A. Sammons Cancer Center
75246 Dallas
United StatesRekrutierend» Google-Maps
Cook Childrens Medical Center
76104 Fort Worth
United StatesNoch nicht rekrutierend» Google-Maps
The University of Texas MD Anderson Cancer Center
77030-4009 Houston
United StatesNoch nicht rekrutierend» Google-Maps
Texas Oncology, P.A. - Tyler; Tyler Cancer Center
75702 Tyler
United StatesRekrutierend» Google-Maps
Northwest Medical Specialties, PLLC; Research Department
98405 Tacoma
United StatesRekrutierend» Google-Maps
Froedtert Hospital
53226 Milwaukee
United StatesNoch nicht rekrutierend» Google-Maps
Kinghorn Cancer Centre; St Vincents Hospital
2010 Darlinghurst
AustraliaNoch nicht rekrutierend» Google-Maps
Sydney Children's Hospital
2031 Randwick
AustraliaNoch nicht rekrutierend» Google-Maps
Princess Alexandra Hospital
4102 Woolloongabba
AustraliaRekrutierend» Google-Maps
Peter MacCallum Cancer Centre; Medical Oncology
3000 Melbourne
AustraliaRekrutierend» Google-Maps
Royal Children's Hospital
3052 Parkville
AustraliaNoch nicht rekrutierend» Google-Maps
Cliniques Universitaires St-Luc
1200 Bruxelles
BelgiumNoch nicht rekrutierend» Google-Maps
GHdC Site Notre Dame
6000 Charleroi
BelgiumNoch nicht rekrutierend» Google-Maps
UZ Leuven Gasthuisberg
3000 Leuven
BelgiumNoch nicht rekrutierend» Google-Maps
Hospital Sírio-Libanês
01308-050 Sao Paulo
BrazilNoch nicht rekrutierend» Google-Maps
Hospital A. C. Camargo; Oncologia
01509-010 Sao Paulo
BrazilNoch nicht rekrutierend» Google-Maps
BC Cancer - Vancouver
V5Z 4E6 Vancouver
CanadaNoch nicht rekrutierend» Google-Maps
London Health Sciences Centre · Victoria Hospital; Department of Medicine
N6A 5W9 London
CanadaNoch nicht rekrutierend» Google-Maps
The Hospital for Sick Children
M5G 1X8 Toronto
CanadaNoch nicht rekrutierend» Google-Maps
Princess Margaret Cancer Center
M5G 2M9 Toronto
CanadaNoch nicht rekrutierend» Google-Maps
McGill University Health Center
H4A 3J1 Montreal
CanadaNoch nicht rekrutierend» Google-Maps
Beijing Children's Hospital, Capital Medical University; Oncological Surgery Department
100032 Beijing City
ChinaNoch nicht rekrutierend» Google-Maps
Beijing Cancer Hospital
100142 Beijing
ChinaNoch nicht rekrutierend» Google-Maps
The First Hospital of Jilin University
130021 Changchun City
ChinaNoch nicht rekrutierend» Google-Maps
Jilin Cancer Hospital
132013 Changchun
ChinaNoch nicht rekrutierend» Google-Maps
West China Hospital - Sichuan University
610047 Chengdu City
ChinaNoch nicht rekrutierend» Google-Maps
Zhongshan Hospital Fudan Unvierstiy
200032 Shanghai City
ChinaNoch nicht rekrutierend» Google-Maps
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
200092 Shanghai
ChinaNoch nicht rekrutierend» Google-Maps
Tianjin Cancer Hospital
300060 Tianjin
ChinaNoch nicht rekrutierend» Google-Maps
First Affiliated Hospital of Medical College of Xi'an Jiaotong University
710061 Xi'an
ChinaNoch nicht rekrutierend» Google-Maps
Aarhus Universitetshospital Skejby; Institut for Klinisk Medicin, Molekylær Medicinsk afdeling
8200 Aarhus N
DenmarkNoch nicht rekrutierend» Google-Maps
Rigshospitalet; Onkologisk Klinik
2100 København Ø
DenmarkNoch nicht rekrutierend» Google-Maps
Institut Bergonie; Oncologie
33076 Bordeaux
FranceNoch nicht rekrutierend» Google-Maps
Centre Oscar Lambret; Service de Pediatrie
59020 Lille
FranceNoch nicht rekrutierend» Google-Maps
CENTRE LEON BERARD; Département d'Hématologie et d'Oncologie
69373 Lyon
FranceNoch nicht rekrutierend» Google-Maps
Hopital de la Timone
13005 Marseille
FranceNoch nicht rekrutierend» Google-Maps
Institut Universitaire du Cancer de Toulouse-Oncopole
31059 Toulouse
FranceNoch nicht rekrutierend» Google-Maps
Institut de Cancerologie Gustave-Roussy (IGR)
94805 Villejuif
FranceNoch nicht rekrutierend» Google-Maps
Hong Kong Children's Hospital
Hong Kong
Hong KongNoch nicht rekrutierend» Google-Maps
Prince of Wales Hospital; Department of Clinical Onocology
Shatin
Hong KongNoch nicht rekrutierend» Google-Maps
Rambam Health Care Campus; Oncology
3109601 Haifa
IsraelNoch nicht rekrutierend» Google-Maps
Hadassah University Hospital - Ein Kerem
9112001 Jerusalem
IsraelNoch nicht rekrutierend» Google-Maps
Rabin MC; Davidof Center - Oncology Institute
4941492 Petach Tikva
IsraelNoch nicht rekrutierend» Google-Maps
Sheba Medical Center
5262100 Ramat Gan
IsraelNoch nicht rekrutierend» Google-Maps
Sourasky / Ichilov Hospital; Dept. of Oncology
6423906 Tel Aviv
IsraelNoch nicht rekrutierend» Google-Maps
Ospedale Pediatrico Bambino Gesù - IRCCS; Dipartimento di Onco-Ematologia Pediatrica
00165 Roma
ItalyNoch nicht rekrutierend» Google-Maps
Policlinico Universitario Agostino Gemelli IRCCS; UOS Fase 1
00168 Roma
ItalyRekrutierend» Google-Maps
Asst Degli Spedali Civili Di Brescia
25100 Brescia
ItalyNoch nicht rekrutierend» Google-Maps
Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1
20133 Milano
ItalyNoch nicht rekrutierend» Google-Maps
Istituto Nazionale Tumori di Milano; S.C. Oncologia Pediatrica
20133 Milano
ItalyNoch nicht rekrutierend» Google-Maps
Dipartimento di Scienze Pediatriche Adolescenza; Osp. Infantile Regina Margherita
10126 Torino
ItalyNoch nicht rekrutierend» Google-Maps
Azienda Ospedaliera Meyer; Centro di Eccellenza di Oncologia ed Ematologia Pediatrica
50139 Firenze
ItalyNoch nicht rekrutierend» Google-Maps
Azienda Ospedaliera Universitaria Senese, U.O.C. Immunoterapia Oncologica
53100 Siena
ItalyNoch nicht rekrutierend» Google-Maps
Seoul National University Bundang Hospital
13605 Seongnam-si
Korea, Republic ofRekrutierend» Google-Maps
Samsung Medical Center
(0)6351 Seoul
Korea, Republic ofNoch nicht rekrutierend» Google-Maps
Seoul National University Hospital
03080 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Severance Hospital, Yonsei University Health System
03722 Seoul
Korea, Republic ofNoch nicht rekrutierend» Google-Maps
Asan Medical Center
05505 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Prinses Maxima Centrum
3584 CS Utrecht
NetherlandsNoch nicht rekrutierend» Google-Maps
Auckland City Hospital, Cancer and Blood Research
1023 Auckland
New ZealandRekrutierend» Google-Maps
Christchurch Hospital; Dept of Oncology
Christchurch
New ZealandNoch nicht rekrutierend» Google-Maps
Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii
80-214 Gdansk
PolandNoch nicht rekrutierend» Google-Maps
Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad; Klinika Nowot.Pluca i Klatki Piers
02-781 Warszawa
PolandRekrutierend» Google-Maps
IPO do Porto; Servico de Oncologia Medica
4200-072 Porto
PortugalNoch nicht rekrutierend» Google-Maps
National University Hospital; National University Cancer Institute, Singapore (NCIS)
119228 Singapore
SingaporeNoch nicht rekrutierend» Google-Maps
National Cancer Centre; Medical Oncology
169610 Singapore
SingaporeRekrutierend» Google-Maps
Hospital Sant Joan De Deu
08950 Esplugues De Llobregas
SpainNoch nicht rekrutierend» Google-Maps
Hospital Univ Vall d'Hebron; Servicio de Oncologia
08035 Barcelona
SpainNoch nicht rekrutierend» Google-Maps
Hospital Infantil Universitario Nino Jesus
28009 Madrid
SpainNoch nicht rekrutierend» Google-Maps
Clinica Universidad de Navarra Madrid; Servicio de Oncología
28027 Madrid
SpainNoch nicht rekrutierend» Google-Maps
START Madrid-FJD, Hospital Fundacion Jimenez Diaz
28040 Madrid
SpainNoch nicht rekrutierend» Google-Maps
Hospital Universitario 12 de Octubre; Servicio de Oncologia
28041 Madrid
SpainNoch nicht rekrutierend» Google-Maps
Hospital Universitario La Paz; Servicio de Oncologia
28046 Madrid
SpainNoch nicht rekrutierend» Google-Maps
START Madrid. Centro Integral Oncologico Clara Campal; CIOCC
28050 Madrid
SpainNoch nicht rekrutierend» Google-Maps
Hospital Universitario la Fe; Servicio de Oncologia
46026 Valencia
SpainNoch nicht rekrutierend» Google-Maps
Universitätsspital Basel (USB)
4031 Basel
SwitzerlandNoch nicht rekrutierend» Google-Maps
Istituto Oncologica della Svizzera Italiana
6500 Bellinzona
SwitzerlandNoch nicht rekrutierend» Google-Maps
Inselspital, Klinik und Poliklinik für Medizinische Onkologie
3012 Bern
SwitzerlandNoch nicht rekrutierend» Google-Maps
Centre Hospitalier Universitaire Vaudois (CHUV) ; Département d'Oncologie médicale - BH09 - Bureau 7
1011 Lausanne
SwitzerlandNoch nicht rekrutierend» Google-Maps
Unversitätsspital Zürich
8091 Zürich
SwitzerlandNoch nicht rekrutierend» Google-Maps
National Cheng Kung University Hospital; Oncology
00704 Tainan
TaiwanNoch nicht rekrutierend» Google-Maps
Taipei Veterans General Hospital; Department of Oncology
112201 Taipei City
TaiwanNoch nicht rekrutierend» Google-Maps
Chang Gung Memorial Hospital-Linkou; Dept of Oncology
333 Taoyuan County
TaiwanNoch nicht rekrutierend» Google-Maps
National Taiwan University Hospital; Oncology
10048 Zhongzheng Dist.
TaiwanNoch nicht rekrutierend» Google-Maps
Beatson West of Scotland Cancer Centre
G12 0YN Glasgow
United KingdomNoch nicht rekrutierend» Google-Maps
University College London Hospital
NW1 - 2PG London
United KingdomNoch nicht rekrutierend» Google-Maps
Royal Manchester Children's Hospital
M13 9WL Manchester
United KingdomNoch nicht rekrutierend» Google-Maps
The Christie NHS Foundation Trust
M20 4BX Manchester
United KingdomNoch nicht rekrutierend» Google-Maps
Royal Marsden Hospital (Sutton)
SM2 5PT Sutton
United KingdomNoch nicht rekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Brief Summary:

TAPISTRY is a Phase II, global, multicenter, open-label, multi-cohort study designed to

evaluate the safety and efficacy of targeted therapies or immunotherapy as single agents or

in rational, specified combinations in participants with unresectable, locally advanced or

metastatic solid tumors determined to harbor specific oncogenic genomic alterations or who

are tumor mutational burden (TMB)-high as identified by a validated next-generation

sequencing (NGS) assay. Participants with solid tumors will be treated with a drug or drug

regimen tailored to their NGS assay results at screening. Participants will be assigned to

the appropriate cohort based on their genetic alteration(s). Treatment will be assigned on

the basis of relevant oncogenotype, will have cohort-specific inclusion/exclusion criteria,

and, unless otherwise specified, will continue until disease progression, loss of clinical

benefit, unacceptable toxicity, participant or physician decision to discontinue, or death,

whichever occurs first.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Histologically or cytologically confirmed diagnosis of advanced and unresectable or

metastatic solid malignancy

- Measurable disease as defined by Response Evaluation Criteria in Solid Tumors, Version

1.1 (RECIST v1.1), Response Assessment in Neuro-Oncology (RANO) criteria, or

International Neuroblastoma Response Criteria (INRC)

- Performance status as follows: Participantss aged >= 18 years: Eastern Cooperative

Oncology Group (ECOG) Performance Status 0-2; Participantss aged 16 to < 18 years:

Karnofsky score >= 50%; Participants aged < 16 years: Lansky score >= 50%

- For participants aged >= 18 and <18 years: adequate hematologic and end-organ function

- Disease progression on prior treatment, or previously untreated disease with no

available acceptable treatment

- Adequate recovery from most recent systemic or local treatment for cancer

- Life expectancy >= 8 weeks

- Ability to comply with the study protocol, in the investigator's judgment

- For female participants of childbearing potential: Negative serum pregnancy test <= 14

days prior to initiating study treatment; agreement to remain abstinent or use single

or combined contraception methods that result in a failure rate of < 1% per year for

the period defined in the cohort-specific inclusion criteria; and agreement to refrain

from donating eggs during the same period

- For male participants: Willingness to remain abstinent or use acceptable methods of

contraception as defined in the cohort-specific inclusion criteria

- In addition to the general inclusion criteria above, participants must meet all of the

cohort-specific inclusion criteria for the respective cohort

Exclusion Criteria:

- Current participation or enrollment in another therapeutic clinical trial

- Any anticancer treatment within 2 weeks or 5 half-lives prior to start of study

treatment

- Whole brain radiotherapy within 14 days prior to start of study treatment

- Stereotactic radiosurgery within 7 days prior to start of study treatment

- Pregnant or breastfeeding, or intending to become pregnant during the study

- History of or concurrent serious medical condition or abnormality in clinical

laboratory tests that, in the investigator's judgment, precludes the participant's

safe participation in and completion of the study or confounds the ability to

interpret data from the study

- Incomplete recovery from any surgery prior to the start of study treatment that would

interfere with the determination of safety or efficacy of study treatment

- Significant cardiovascular disease, such as New York Heart Association cardiac disease

(Class II or higher), myocardial infarction, or cerebrovascular accident within 3

months prior to enrollment, unstable arrhythmias, or unstable angina

- History of another active cancer within 5 years prior to screening that may interfere

with the determination of safety or efficacy of study treatment with respect to the

qualifying solid tumor malignancy

- In addition to the general exclusion criteria above, in order to be enrolled in a

treatment cohort of the study, participants must not meet any of the cohort-specific

exclusion criteria

Studien-Rationale

Primary outcome:

1. All Cohorts: Independent Review Committee (IRC)-assessed objective response rate (ORR) based on confirmed objective response (OR) per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) (Time Frame - Approximately up to 12 years):
Confirmed objective response indicates >/= 4 weeks after initial documentation of response



Secondary outcome:

1. All Cohorts: IRC-assessed duration of response (DOR) per RECIST v1.1 (Time Frame - Approximately up to 12 years)

2. All Cohorts: IRC-assessed clinical benefit rate (CBR) per RECIST v1.1 (Time Frame - Approximately up to 12 years)

3. All Cohorts: IRC-assessed progression free survival (PFS) per RECIST v1.1 (Time Frame - Approximately up to 12 years)

4. All Cohorts: Investigator (INV)-assessed ORR per RECIST v1.1 (Time Frame - Approximately up to 12 years)

5. All Cohorts: INV-assessed DOR per RECIST v1.1 (Time Frame - Approximately up to 12 years)

6. All Cohorts: INV-assessed CBR per RECIST v1.1 (Time Frame - Approximately up to 12 years)

7. All Cohorts: INV-assessed PFS per RECIST v1.1 (Time Frame - Approximately up to 12 years)

8. All Cohorts: IRC- and INV-assessed time to central nervous system (CNS) progression per RECIST v1.1 (Time Frame - Approximately up to 12 years)

9. All Cohorts: Overall Survival (OS) (Time Frame - Approximately up to 12 years)

10. Cohorts A, B, C, D, I, J, K: IRC-assessed CNS-ORR per Response Assessment in Neuro-Oncology (RANO) (Time Frame - Approximately up to 12 years)

11. Cohorts A, B, C, D, I, J, K: IRC-assessed CNS-DOR per RANO (Time Frame - Approximately up to 12 years)

12. Cohorts A, B, C, D, I, J, K: IRC-assessed CNS-CBR per RANO (Time Frame - Approximately up to 12 years)

13. Cohorts A, B, C, D, I, J, K: IRC-assessed CNS-PFS per RANO (Time Frame - Approximately up to 12 years)

14. Cohorts A, B, C, D, I, J, K: INV-assessed CNS-ORR per RANO (Time Frame - Approximately up to 12 years)

15. Cohorts A, B, C, D, I, J, K: INV-assessed CNS-DOR per RANO (Time Frame - Approximately up to 12 years)

16. Cohorts A, B, C, D, I, J, K: INV-assessed CNS-CBR per RANO (Time Frame - Approximately up to 12 years)

17. Cohorts A, B, C, D, I, J, K: INV-assessed CNS-PFS per RANO (Time Frame - Approximately up to 12 years)

18. Cohorts A, B, D, E, F, H, I, J, K: IRC-assessed ORR per International Neuroblastoma Response Criteria (INRC) (Time Frame - Approximately up to 12 years)

19. Cohorts A, B, D, E, F, H, I, J, KIRC-assessed DOR per INRC (Time Frame - Approximately up to 12 years)

20. Cohorts A, B, D, E, F, H, I, J, K: IRC-assessed CBR per INRC (Time Frame - Approximately up to 12 years)

21. Cohorts A, B, D, E, F, H, I, J, K: IRC-assessed PFS per INRC (Time Frame - Approximately up to 12 years)

22. Cohorts A, B, D, E, F, H, I, J, K: INV-assessed ORR per INRC (Time Frame - Approximately up to 12 years)

23. Cohorts A, B, D, E, F, H, I, J, K: INV-assessed DOR per INRC (Time Frame - Approximately up to 12 years)

24. Cohorts A, B, D, E, F, H, I, J, K: INV-assessed CBR per INRC (Time Frame - Approximately up to 12 years)

25. Cohorts A, B, D, E, F, H, I, J, K: INV-assessed PFS per INRC (Time Frame - Approximately up to 12 years)

26. All Cohorts: IRC-assessed ORR per RECIST v1.1 in participants with alteration/biomarker-positive circulating tumor DNA (ctDNA) by blood-based next-generation sequencing (NGS) assay (Time Frame - Approximately up to 12 years)

27. All Cohorts: IRC-assessed DOR per RECIST v1.1 in participants with alteration/biomarker-positive ctDNA by blood-based NGS assay (Time Frame - Approximately up to 12 years)

28. All Cohorts: IRC-assessed CBR per RECIST v1.1 in participants with alteration/biomarker-positive ctDNA by blood-based NGS assay (Time Frame - Approximately up to 12 years)

29. All Cohorts: IRC-assessed PFS per RECIST v1.1 in participants with alteration/biomarker-positive ctDNA by blood-based NGS assay (Time Frame - Approximately up to 12 years)

30. All Cohorts: INV-assessed ORR per RECIST v1.1 in participants with alteration/biomarker-positive ctDNA by blood-based NGS assay (Time Frame - Approximately up to 12 years)

31. All Cohorts: INV-assessed DOR per RECIST v1.1 in participants with alteration/biomarker-positive ctDNA by blood-based NGS assay (Time Frame - Approximately up to 12 years)

32. All Cohorts: INV-assessed CBR per RECIST v1.1 in participants with alteration/biomarker-positive ctDNA by blood-based NGS assay (Time Frame - Approximately up to 12 years)

33. All Cohorts: INV-assessed PFS per RECIST v1.1 in participants with alteration/biomarker-positive ctDNA by blood-based NGS assay (Time Frame - Approximately up to 12 years)

34. Cohorts A, B, C, D, I, J, K: IRC-assessed intracranial (IC)-ORR per RECIST v1.1 (Time Frame - Approximately up to 12 years)

35. Cohorts A, B, C, D, I, J, K: IRC-assessed IC-DOR per RECIST v1.1 (Time Frame - Approximately up to 12 years)

36. Cohorts A, B, C, D, I, J, K: IRC-assessed IC-CBR per RECIST v1.1 (Time Frame - Approximately up to 12 years)

37. Cohorts A, B, C, D, I, J, K: IRC-assessed IC-PFS rate per RECIST v1.1 (Time Frame - Approximately up to 12 years)

38. Cohorts A, B, C, D, I, J, K: INV-assessed IC-ORR per RECIST v1.1 (Time Frame - Approximately up to 12 years)

39. Cohorts A, B, C, D, I, J, K: INV-assessed IC-DOR per RECIST v1.1 (Time Frame - Approximately up to 12 years)

40. Cohorts A, B, C, D, I, J, K: INV-assessed IC-CBR per RECIST v1.1 (Time Frame - Approximately up to 12 years)

41. Cohorts A, B, C, D, I, J, K: INV-assessed IC-PFS rate per RECIST v1.1 (Time Frame - Approximately up to 12 years)

42. All Cohorts: Percentage of participants with confirmed deterioration as assessed by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) (Time Frame - Approximately up to 12 years):
The EORTC QLQ-C30 is a validated, reliable self-report measure. It consists of 30 questions that assess five aspects of participant functioning (physical, emotional, role, cognitive, and social), eight symptom scales (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea) and global health/quality of life, with a recall period of the previous week. Scale scores can be obtained for the multi-item scales using rating scales of 4 or 7 points.

43. All Cohorts: Change from Baseline in the EORTC-QLQ-C30 total score (Time Frame - Approximately up to 12 years)

44. All Cohorts: Percentage of participants with a clinical meaningful change on the Global Health Status, Physical Functioning, and Role Functioning scores from the EORTC QLQ-C30 (Time Frame - Approximately up to 12 years)

45. All Cohorts: Time to confirmed symptom onset or worsening from tumor-related symptom scores from the EORTC QLQ-C30 and EORTC Item Library (Time Frame - Approximately up to 12 years):
The EORTC Item library includes stand-alone symptoms scales and an overall assessment of treatment bother to provide additional information not currently captured in the EORTC QLQ-C30. The scales use the same rating scale and recall period of previous week as the symptom scales in the EORTC QLQ-C30.

46. All Cohorts: Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) (Time Frame - Approximately up to 12 years):
Adverse event severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5 (NCI CTCAE v5.0.)

47. Cohorts A, B: Plasma concentration of entrectinib at specified timepoints (Time Frame - Day 1 of Cycle 1-6 and Day 1 of every other Cycle going forward (one Cycle=28 days))

48. Cohort C: Plasma concentration of alectinib at specified timepoints (Time Frame - Cycle 1, Day 1 and Day 15; Day 1 of Cycle 2-6, and Day 1 of every other Cycle going forward (one Cycle=28 days))

49. Cohort D: Plasma concentration of atezolizumab at specified timepoints (Time Frame - Day 1 of Cycle 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, and every even Cycles thereafter (one Cycle=21 days))

50. Cohort E: Plasma concentration of ipatasertib at specified timepoints (Time Frame - Cycle 1, Day 1 and 15; Cycle 2, Day 1; Cycle 3, Day 15; Cycle 4, Day 1, and every even Cycle thereafter (one Cycle=28 days))

51. Cohort F: Serum concentration of trastuzumab emtansine at specified timepoints (Time Frame - Cycle 1, Day 1; Cycle 2, Day 1; Cycle 4, Day 1; Cycle 6, Day 1, and every even Cycle thereafter (one Cycle=21 days))

52. Cohort G: Plasma concentration of idasanutlin at specified timepoint (Time Frame - Cycle 1, Day 1, 2, 5, 8; Cycle 2, Day 1, 2, 5; Cycle 3, Day 2, 5; Cycle 4, Day 1, and every other Cycle going forward (one Cycle=28 days))

53. Cohort H: Plasma concentration of GDC-0077 at specified timepoints (Time Frame - Cycle 1, Day 1, 8 (+/-1 day), 15 (+/-1 day); Cycle 2, Day 1 (+/-1 day); Day 1 of Cycle 4, and every other even Cycle going forward (one Cycle=28 days))

54. Cohorts D, F: Percentage of participants with anti-drug antibodies (ADA) (Time Frame - Cohort D: Day 1 of Cycle 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, and every even Cycles thereafter (one Cycle=21 days); Cohort F: Cycle 1, Day 1; Cycle 2, Day 1; Cycle 4, Day 1; Cycle 6, Day 1, and every even Cycle thereafter (one Cycle=21 days))

Studien-Arme

  • Experimental: Cohort A: ROS1 fusion-positive tumors
    Participants with metastatic or advanced solid tumors, with the exception of NSCLC will receive entrectinib once daily in repeated 28-day cycles at a dose of 600 milligram per day (mg/day) for adults and pediatric participants with a body surface area (BSA) >/= 1.51 squaremeter (m2). The total dose of daily entrectinib administration for pediatric participants with BSA<1.51 m2 will be lower.
  • Experimental: Cohort B: NTRK1/2/3 fusion-positive tumors
    Participants with metastatic or advanced solid tumors will receive entrectinib once daily in repeated 28-day cycles at a dose of 600 mg/day for adults and pediatric participants with a BSA >/= 1.51 m2. The total dose of daily entrectinib administration for pediatric participants with BSA<1.51 m2 will be lower.
  • Experimental: Cohort C: ALK fusion-positive tumors
    Participants with metastatic or advanced solid tumors, with the exception of NSCLC, will receive alectinib at a dosage of 600 mg orally twice a day (BID), taken with food, in repeated 28-day cycles.
  • Experimental: Cohort D: TMB-high tumors
    Participants with metastatic or advanced solid tumors will receive atezolizumab intravenously (IV) at a fixed dose for participants aged >/= 18 years, and 15 mg/kg (maximum 1200 mg) for participants aged < 18 years on Day 1 of each 21-day cycle.
  • Experimental: Cohort E: AKT1/2/3 mutant-positive tumors
    Participants with metastatic or advanced solid tumors will receive ipatasertib orally once daily (QD) at the starting dose of 400 mg in repeated 28-day cycles until the participant experiences disease progression, intolerable toxicity, or withdraws consent. For participants 12-17 years of age, ipatasertib will be administered at the starting dose of 200 mg for participants <35 kg, 300 mg for participants >/= 35 and <45 kg, 400 mg for those >/=45 kg orally QD in repeated 28-day cycles until the participant experiences disease progression, intolerable toxicity, or withdraws consent.
  • Experimental: Cohort F: HER2 mutant-positive tumors
    Participants with metastatic or advanced solid tumors will receive trastuzumab emtansine IV at a dose of 3.6 mg/kg every 21 days.
  • Experimental: Cohort G: MDM2-amplified, TP53 wild-type tumors
    Participants with metastatic or advanced solid tumors will receive idasanutlin at a dose of 250 mg orally QD on Days 1-5 of each 28-day cycle. Note: Cohort G has been closed for enrollment
  • Experimental: Cohort H: PIK3CA multiple mutant-positive tumors
    Participants with metastatic or advanced solid tumors will receive GDC-0077 QD at a starting dose of 9 mg by mouth (PO) in repeated 28-day cycles.
  • Experimental: Cohort I: BRAF class II mutant or fusion-positive tumors
    Participants with BRAF class II mutant/fusion-positive tumors (adults and adolescents ≥ 40 kg) will receive 400 mg belvarafenib by mouth (PO) BID (twice a day) with adequate water (more than 200 mL). One cycle consists of 28 days. Administration of belvarafenib should occur BID on every day of each 28-day cycle.
  • Experimental: Cohort J: BRAF class III mutant-positive tumors
    Participants with BRAF class III mutant-positive tumors(adults and adolescents ≥ 40 kg) will receive 400 mg belvarafenib by mouth (PO) BID (twice a day) with adequate water (more than 200 mL). One cycle consists of 28 days. Administration of belvarafenib should occur BID on every day of each 28-day cycle.
  • Experimental: Cohort K: RET fusion-positive tumors
    Participants with RET fusion-positive tumors will self-administer Pralsetinib orally at home (except on clinic days) on a continuous daily dosing regimen at a dose of 400 mg/day (four 100-mg capsules per day) for adult and pediatric patients ≥ 12 and < 18 years of age. A treatment cycle consists of 4 weeks (28 days).

Geprüfte Regime

  • Entrectinib (Rozlytrek):
    Adults and pediatric participants with a BSA >/= 1.51 m2: entrectinib will be self-administered by participants orally at home at a dose of 600 mg/day (three 200-mg capsules per day). Pediatric participants with a BSA < 1.51 m2: entrectinib will be administered orally at home in mini-tablet formulation at a dose of 400 mg/day (BSA=1.11-1.50 m2) or 300 mg/day (BSA=0.81-1.10 m2) or 200 mg/day (BSA=0.51-0.80 m2) or 100 mg/day (BSA=0.43-0.50 m2).
  • Entrectinib (Rozlytrek):
    Adults and pediatric participants with a BSA >/= 1.51 m2: entrectinib will be self-administered by participants orally at home at a dose of 600 mg/day (three 200-mg capsules per day). Pediatric participants with a BSA < 1.51 m2: entrectinib will be administered orally at home in mini-tablet formulation at a dose of 400 mg/day (BSA=1.11-1.50 m2) or 300 mg/day (BSA=0.81-1.10 m2) or 200 mg/day (BSA=0.51-0.80 m2) or 100 mg/day (BSA=0.43-0.50 m2).
  • Alectinib (Alecensa):
    Alectinib will be administered orally BID (twice a day) with food at a dosage of 600 mg (four 150-mg capsules).
  • Atezolizumab (Tecentriq):
    Atezolizumab will be administered by IV infusion at a fixed dose of 1200 mg for participants aged >/=18 years, and 15 mg/kg (maximum 1200 mg) for participants aged <18 years on Day 1 of each 21-day cycle.
  • Ipatasertib:
    For participants 12-17 years of age, ipatasertib will be administered at the starting dose of 200 mg for participants < 35 kg, 300 mg for participants >/= 35 and < 45 kg, 400 mg for those >/= 45 kg orally QD, beginning of Cycle 1, on Days 1-21 of each 28-day cycle until the participant experiences disease progression, intolerable toxicity, or withdraws consent.
  • Trastuzumab emtansine (Kadcyla):
    Trastuzumab emtansine will be administered at 3.6 mg/kg by IV infusion every 21 days until disease progression or unacceptable toxicity. The dosage and administration method also applies for pediatric participants 12-17 years of age.
  • Idasanutlin:
    Idasanutlin will be administered at 250 mg QD (daily) PO for Days 1-5 of each 28-day cycle. Idasanutlin may be given without regard to meals and water can be given as often as necessary or desired. The daily doses should be administered 10-14 hours apart. Note: Cohort G has been closed for enrollment.
  • Inavolisib (GDC-0077):
    GDC-077 will be administered QD at a starting dose of 9 mg PO in repeated 28-day cycles. The dosage and administration method also applies for pediatric participants 12-17 years of age.
  • Belvarafenib:
    Belvarafenib will be administered at a dose 400 mg (PO) BID with adequate water (more than 200 mL). One cycle consists of 28 days. Administration of belvarafenib should occur BID on every day of each 28-day cycle.
  • Pralsetinib (Gavreto (US)):
    Pralsetinib will be self-administered by participants orally at home (except on clinic days) on a continuous daily dosing regimen at a dose of 400 mg/day (four 100-mg capsules per day) for adult and pediatric patients ≥ 12 and < 18 years of age. A treatment cycle consists of 4 weeks (28 days).

Quelle: ClinicalTrials.gov


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