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JOURNAL ONKOLOGIE – STUDIE

VISION Tepotinib Phase II in Non-small Cell Lung Cancer (NSCLC) Harboring MET Alterations

Rekrutierend

NCT-Nummer:
NCT02864992

Studienbeginn:
September 2016

Letztes Update:
23.02.2021

Wirkstoff:
Tepotinib

Indikation (Clinical Trials):
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 2

Sponsor:
EMD Serono Research & Development Institute, Inc.

Collaborator:
Merck KGaA, Darmstadt, Germany

Studienleiter

Medical Responsible
Study Director
EMD Serono Research & Development Institute, Inc, a business of Merck KGaA, Darmstadt, Germany

Kontakt

Studienlocations (3 von 151)

Asklepios Fachkliniken Muenchen-Gauting
82131 Gauting
(Bayern)
GermanyAktiv, nicht rekrutierend» Google-Maps
Pius-Hospital Oldenburg
26121 Oldenburg
(Niedersachsen)
GermanyAktiv, nicht rekrutierend» Google-Maps
Universitaetsklinikum des Saarlandes
66421 Homburg / Saar
(Saarland)
GermanyAktiv, nicht rekrutierend» Google-Maps
Klinikum Chemnitz gGmbH
09113 Chemnitz
(Sachsen)
GermanyAktiv, nicht rekrutierend» Google-Maps
Staedtisches Klinikum Dresden Standort Dresden-Friedrichstadt
01067 Dresden
(Sachsen)
GermanyRekrutierend» Google-Maps
Universitaetsklinikum Carl Gustav Carus TU Dresden
01307 Dresden
(Sachsen)
GermanyAktiv, nicht rekrutierend» Google-Maps
POIS Leipzig GbR
04357 Leipzig
(Sachsen)
GermanyAktiv, nicht rekrutierend» Google-Maps
Lungenkrebszentrum Helios Klinikum Erfurt
Nordhäuser Straße 74
99089 Erfurt
(Thüringen)
DeutschlandAktiv, nicht rekrutierend» Google-Maps
SRH Wald-Klinikum Gera gGmbH
07548 Gera
(Thüringen)
GermanyAktiv, nicht rekrutierend» Google-Maps
Charite Universitaetsmedizin Berlin - Campus Charite Mitte
10117 Berlin
(Berlin)
GermanyAktiv, nicht rekrutierend» Google-Maps
Universitaetsmedizin Goettingen
Goettingen
(Niedersachsen)
GermanyAktiv, nicht rekrutierend» Google-Maps
Evangelisches Krankenhaus Hamm GmbH
Hamm
(Nordrhein-Westfalen)
GermanyAktiv, nicht rekrutierend» Google-Maps
Universitaetsklinikum Heidelberg
69126 Heidelberg
(Baden-Württemberg)
GermanyAktiv, nicht rekrutierend» Google-Maps
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
Mainz
(Rheinland-Pfalz)
GermanyAktiv, nicht rekrutierend» Google-Maps
City of Hope Cancer Center
91010 Duarte
United StatesAktiv, nicht rekrutierend» Google-Maps
Torrance Health Association
90277 Redondo Beach
United StatesAktiv, nicht rekrutierend» Google-Maps
St Joseph Heritage Healthcare
95403 Santa Rosa
United StatesAktiv, nicht rekrutierend» Google-Maps
Rocky Mountain Cancer Centers, LLP
80218 Denver
United StatesAktiv, nicht rekrutierend» Google-Maps
Holy Cross Hospital Inc.
33308 Fort Lauderdale
United StatesAktiv, nicht rekrutierend» Google-Maps
University Cancer & Blood Center, LLC
30607 Athens
United StatesZurückgezogen» Google-Maps
Winship Cancer Institute
30322 Atlanta
United StatesAktiv, nicht rekrutierend» Google-Maps
University of Chicago Medical Center
60637 Chicago
United StatesAktiv, nicht rekrutierend» Google-Maps
Ingalls Hospital
60426-3558 Harvey
United StatesAktiv, nicht rekrutierend» Google-Maps
Community Regional Cancer Care
46250 Indianapolis
United StatesAktiv, nicht rekrutierend» Google-Maps
St. Louis Cancer Care, LLP
63044 Bridgeton
United StatesAktiv, nicht rekrutierend» Google-Maps
Saint Louis University
63110 Saint Louis
United StatesAktiv, nicht rekrutierend» Google-Maps
Regional Cancer Care Associates East Brunswick
08816 East Brunswick
United StatesAktiv, nicht rekrutierend» Google-Maps
Hackensack University Medical Center PARTNER
07601 Hackensack
United StatesAktiv, nicht rekrutierend» Google-Maps
The Valley Hospital
07450 Ridgewood
United StatesAktiv, nicht rekrutierend» Google-Maps
UC Health Clinical Trials Office
45229 Cincinnati
United StatesAktiv, nicht rekrutierend» Google-Maps
Tennessee Oncology
37203 Nashville
United StatesAktiv, nicht rekrutierend» Google-Maps
Vanderbilt University Medical Center
37232 Nashville
United StatesAktiv, nicht rekrutierend» Google-Maps
Texas Oncology, P.A. - Austin
78731 Austin
United StatesAktiv, nicht rekrutierend» Google-Maps
Texas Oncology, PA
77702-1449 Beaumont
United StatesAktiv, nicht rekrutierend» Google-Maps
University of Texas MD Anderson Cancer Center
77030 Houston
United StatesRekrutierend» Google-Maps
Virginia Cancer Specialists, PC
22031 Fairfax
United StatesAktiv, nicht rekrutierend» Google-Maps
Swedish Medical Center
98104 Seattle
United StatesAktiv, nicht rekrutierend» Google-Maps
Wenatchee Valley Hospital & Clinics - ATTN: Jay Johnson
98801 Wenatchee
United StatesAktiv, nicht rekrutierend» Google-Maps
LKH - Universitätsklinikum der PMU Salzburg - Innere Med III/Hämatologie und Onkologie
Salzburg
AustriaAktiv, nicht rekrutierend» Google-Maps
Groupe Hospitalier Sud - Hôpital Haut-Lévêque
33604 Pessac
FranceAktiv, nicht rekrutierend» Google-Maps
CHU de Toulouse - Hôpital Larrey
31059 Toulouse
FranceRekrutierend» Google-Maps
ICO - Site René Gauducheau
44805 Saint Herblain
FranceAktiv, nicht rekrutierend» Google-Maps
Clinique Mutualiste de l'Estuaire
44606 Saint Nazaire Cedex
FranceAktiv, nicht rekrutierend» Google-Maps
ICO - Site Paul Papin
49055 Angers Cedex 2
FranceAktiv, nicht rekrutierend» Google-Maps
Centre Hospitalier de Cholet
49300 Cholet
FranceAktiv, nicht rekrutierend» Google-Maps
Centre Hospitalier de Bretagne Sud
56322 Lorient cedex
FranceAktiv, nicht rekrutierend» Google-Maps
Hopital Albert Calmette - CHU Lille
59037 Lille Cedex
FranceAktiv, nicht rekrutierend» Google-Maps
Centre Hospitalier Intercommunal de Créteil
94010 Creteil cedex
FranceAktiv, nicht rekrutierend» Google-Maps
Centre Hospitalier Départemental Les Oudairies
85925 La Roche sur Yon
FranceAktiv, nicht rekrutierend» Google-Maps
Soroka University Medical Center
Beer-Sheva
IsraelAktiv, nicht rekrutierend» Google-Maps
Hadassah University Hospital - Ein Kerem
Jerusalem
IsraelAktiv, nicht rekrutierend» Google-Maps
Meir Medical Center
Kfar- Saba
IsraelAktiv, nicht rekrutierend» Google-Maps
Rabin Medical Center-Beilinson Campus
Petach Tikva
IsraelAktiv, nicht rekrutierend» Google-Maps
Tel Aviv Sourasky Medical Center
Tel Aviv
IsraelAktiv, nicht rekrutierend» Google-Maps
Istituto Clinico Humanitas
20089 Rozzano
ItalyAktiv, nicht rekrutierend» Google-Maps
Istituto Nazionale per la Ricerca sul Cancro di Genova
16132 Genova
ItalyAktiv, nicht rekrutierend» Google-Maps
Fondazione IRCCS Istituto Nazionale dei Tumori
20133 Milano
ItalyRekrutierend» Google-Maps
Ansprechpartner:
Marina Garassino
Phone: +390223903066
E-Mail: garassino.studiclinici@istitutotumori.mi.it
» Ansprechpartner anzeigen
IEO Istituto Europeo di Oncologia
20141 Milano
ItalyAktiv, nicht rekrutierend» Google-Maps
Seconda Università degli Studi di Napoli
80131 Napoli
ItalyAktiv, nicht rekrutierend» Google-Maps
Azienda Ospedaliera di Padova
35128 Padova
ItalyAktiv, nicht rekrutierend» Google-Maps
IOV - Istituto Oncologico Veneto IRCCS
35128 Padova
ItalyAktiv, nicht rekrutierend» Google-Maps
Ospedale Santa Maria di Cà Foncello
35128 Padova
ItalyRekrutierend» Google-Maps
Università Campus Bio-Medico di Roma
00128 Roma
ItalyAktiv, nicht rekrutierend» Google-Maps
Azienda Ospedaliera San Camillo Forlanini
00149 Roma
ItalyAktiv, nicht rekrutierend» Google-Maps
Nagoya University Hospital
466-8560 Nagoya-shi
JapanAktiv, nicht rekrutierend» Google-Maps
National Cancer Center Hospital East
277-8577 Kashiwa-shi
JapanAktiv, nicht rekrutierend» Google-Maps
NHO Shikoku Cancer Center
791-0280 Matsuyama-shi
JapanAktiv, nicht rekrutierend» Google-Maps
NHO Kyushu Medical Center
810-8563 Fukuoka-shi
JapanAktiv, nicht rekrutierend» Google-Maps
Kurume University Hospital
830-0011 Kurume-shi
JapanAktiv, nicht rekrutierend» Google-Maps
Hokkaido University Hospital
060-8648 Sapporo-shi
JapanAktiv, nicht rekrutierend» Google-Maps
Kanagawa Cancer Center
241-8515 Yokohama-shi
JapanAktiv, nicht rekrutierend» Google-Maps
Niigata Cancer Center Hospital
951-8566 Niigata-shi
JapanAktiv, nicht rekrutierend» Google-Maps
Osaka International Cancer Institute
541-8567 Osaka-shi
JapanAktiv, nicht rekrutierend» Google-Maps
NHO Kinki-Chuo Chest Medical Center
591-8555 Sakai-shi
JapanAktiv, nicht rekrutierend» Google-Maps
Saitama Cancer Center
362-0806 Kitaadachi-gun
JapanRekrutierend» Google-Maps
Tottori University Hospital
683-8504 Yonago-shi
JapanAktiv, nicht rekrutierend» Google-Maps
NHO Yamaguchi - Ube Medical Center
755-0241 Ube-shi
JapanAktiv, nicht rekrutierend» Google-Maps
Dong-A University Hospital
Busan
Korea, Republic ofAbgebrochen» Google-Maps
Kosin University Gospel Hospital
Busan
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
Kyungpook National University Medical Center
Daegu
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
National Cancer Center
Goyang-si
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
Korea University Guro Hospital
Guro-Gu
Korea, Republic ofZurückgezogen» Google-Maps
Chonnam National University Hwasun Hospital
Hwasun-gun
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
Gachon University Gil Medical Center
Incheon
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
Seoul National University Bundang Hospital
Seongnam-si
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
Korea University Anam Hospital
Seoul
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
Severance Hospital, Yonsei University
Seoul
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
The Catholic University of Korea, St. Vincent's Hospital
Suwon-si
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
Ajou University Hospital
Suwon
Korea, Republic ofZurückgezogen» Google-Maps
Ulsan University Hospital
Ulsan
Korea, Republic ofZurückgezogen» Google-Maps
Antoni van Leeuwenhoek Ziekenhuis
Amsterdam
NetherlandsAktiv, nicht rekrutierend» Google-Maps
VU Medisch Centrum
Amsterdam
NetherlandsAktiv, nicht rekrutierend» Google-Maps
Universitair Medisch Centrum Groningen (UMCG) - Parent
Groningen
NetherlandsAktiv, nicht rekrutierend» Google-Maps
Centrum Pulmonologii i Torakochirurgii w Bystrej
43-360 Bystra
PolandAktiv, nicht rekrutierend» Google-Maps
Dr n med. Slawomir Mandziuk Specjalistyczna Praktyka Lekarska
20-093 Lublin
PolandAktiv, nicht rekrutierend» Google-Maps
NZOZ Olsztynski Osr. Onkologiczny "Kopernik" Sp.z o.o
10-513 Olsztyn
PolandAktiv, nicht rekrutierend» Google-Maps
Przychodnia Med-Polonia Sp. z o.o.
60-693 Poznan
PolandAktiv, nicht rekrutierend» Google-Maps
Centrum Onkologii-Instytut im. M. Sklodowskiej Curie
02-781 Warszawa
PolandAktiv, nicht rekrutierend» Google-Maps
Hospital General de Catalunya
08190 Sant Cugat del Valles
SpainAktiv, nicht rekrutierend» Google-Maps
Hospital Universitario HM Puerta del Sur
28938 Mostoles
SpainZurückgezogen» Google-Maps
Hospital Universitario Infanta Sofia
28702 San Sebastian de los Reyes
SpainAbgebrochen» Google-Maps
Hospital General Universitario Santa Lucia
30202 Cartagena
SpainAktiv, nicht rekrutierend» Google-Maps
Hospital Clinico Universitario Virgen de la Victoria
29010 Malaga
SpainAktiv, nicht rekrutierend» Google-Maps
Hospital Universitari Quiron Dexeus
08028 Barcelona
SpainRekrutierend» Google-Maps
Hospital Universitari Sagrat Cor
08029 Barcelona
SpainAbgebrochen» Google-Maps
Hospital General Universitario Gregorio Marañon
28007 Madrid
SpainAktiv, nicht rekrutierend» Google-Maps
Hospital Universitario 12 de Octubre
28041 Madrid
SpainRekrutierend» Google-Maps
Hospital Universitario La Paz
28046 Madrid
SpainAktiv, nicht rekrutierend» Google-Maps
Hospital Universitario HM Madrid Sanchinarro
28050 Madrid
SpainRekrutierend» Google-Maps
Ansprechpartner:
Javier de Castro Carpeño
Phone: +34917277516
E-Mail: javier.decastro@salud.madrid.org
» Ansprechpartner anzeigen
Hospital Universitario Virgen Macarena
41009 Sevilla
SpainAktiv, nicht rekrutierend» Google-Maps
Hospital Universitario Nuestra Señora de Valme
41014 Sevilla
SpainAktiv, nicht rekrutierend» Google-Maps
Inselspital - Universitaetsspital Bern - Klinik und Poliklinik für Medizinische Onkologie
Bern
SwitzerlandAktiv, nicht rekrutierend» Google-Maps
Universitaetsspital Zuerich - Klinik fuer Onkologie
Zuerich
SwitzerlandAktiv, nicht rekrutierend» Google-Maps
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung
TaiwanAktiv, nicht rekrutierend» Google-Maps
China Medical University Hospital
Taichung
TaiwanAktiv, nicht rekrutierend» Google-Maps
Taichung Veterans General Hospital
Taichung
TaiwanAktiv, nicht rekrutierend» Google-Maps
Taipei Veterans General Hospital
Taipei
TaiwanAktiv, nicht rekrutierend» Google-Maps
Tri-Service General Hospital
Taipei
TaiwanAktiv, nicht rekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Detailed Description:

The study includes 3 cohorts with one primary endpoint (Objective Response Rate). Enrollment

number and completion data is changed by new cohorts.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Signed, written informed consent by subject or legal representative prior to any

trial-specific screening procedure

- Male or female, greater than or equal to (>=) 18 years of age (or having reached the

age of majority according to local laws and regulations

- Measurable disease confirmed by an independent review committee (IRC) in accordance

with RECIST version 1.1

- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1

- A female subject is eligible to participate if she is not pregnant, not breastfeeding,

and at least one of the following conditions applies:

- Not a woman of childbearing potential OR

- A woman of childbearing potential who agrees to use a highly effective contraception

- A male subject must agree to use and to have their female partners of childbearing

potential to use a highly effective contraception

- Histologically or cytologically confirmed advanced (locally advanced or metastatic)

NSCLC (all types including squamous and sarcomatoid)

- Treatment naïve patients in first-line or pretreated patients with no more than 2

lines of prior therapy

- Subjects with MET alterations, namely METex14 skipping alterations in plasma and/or

tissue as determined by the central laboratory or by an assay with appropriate

regulatory status

Exclusion Criteria:

- Subjects with characterized Epidermal Growth Factor Receptor (EGFR) activating

mutations that predict sensitivity to anti-EGFR-therapy

- Subjects with characterized Anaplastic Lymphoma Kinase (ALK) rearrangements that

predict sensitivity to anti-ALK therapy

- Subjects with symptomatic brain metastases who are neurologically unstable

- Any unresolved toxicity Grade 2 or more according to National Cancer Institute Common

Terminology Criteria for Adverse Events (NCI-CTCAE) from previous anticancer therapy

- Need for transfusion within 14 days prior to the first dose of trial treatment

- Prior chemotherapy, biological therapy, radiation therapy, hormonal therapy for

anti-cancer purposes, targeted therapy, or other investigational anticancer therapy

(not including palliative radiotherapy at focal sites) within 21 days prior to the

first dose of trial treatment;

- Subjects who have brain metastasis as the only measurable lesion

- Inadequate hematological, liver, renal, cardiac function

- Prior treatment with other agents targeting the Hepatocyte Growth Factor c(HGF/c) -Met

pathway

- Hypertension uncontrolled by standard therapies (not stabilized to < 150/90 mmHg)

- Past or current history of neoplasm other than Non-small Cell Lung Cancer (NSCLC),

except for curatively treated non-melanoma skin cancer, in situ carcinoma of the

cervix, or other cancer curatively treated and with no evidence of disease for at

least 5 years

- Medical history of difficulty swallowing, malabsorption, or other chronic

gastrointestinal disease, or conditions that may hamper compliance and/or absorption

of the test product

- Major surgery within 28 days prior to Day 1 of trial treatment

- Known infection with human immunodeficiency virus, or an active infection with

hepatitis B or hepatitis C virus

- Substance abuse, active infection, or other acute or chronic medical or psychiatric

condition or laboratory abnormalities that might increase the risk associated with

trial participation at the discretion of Investigators

- Known hypersensitivity to any of the trial treatment ingredients

- Legal incapacity or limited legal capacity

- Any other reason that, in the opinion of the Principal Investigator, precludes the

subject from participating in the trial

- Participation in another clinical trial within the past 30 days

Studien-Rationale

Primary outcome:

1. Objective response as assessed by independent review committee (Time Frame - Baseline up to 20 months):
Objective response will be determined according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and as adjudicated by an Independent review committee. Objective response is defined as either a confirmed complete response (CR) or partial response (PR) from first administration of trial treatment to first observation of progressive disease (PD). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in the sum of the longest diameter (SLD) of all lesions. PD is defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.



Secondary outcome:

1. Objective response assessed as per Investigator (Time Frame - Baseline up to 20 months):
Objective response will be determined according to RECIST 1.1 and as per investigator's discretion. Objective response is defined as either a confirmed complete response (CR) or partial response (PR) from first administration of trial treatment to first observation of progressive disease (PD) .CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. PD is defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.

2. Duration of response as assessed by independent review committee (Time Frame - Baseline until PD/ death within 84 days of last tumor assessment; assessed up to 20 months):
Duration of response according to RECIST 1.1 and as adjudicated by an Independent review committee is the time from when the CR/PR (whichever is first) criteria are first met until progression of disease (PD) or death due to any cause within 84 days of the last tumor assessment, whichever occurs first. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. PD is defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.

3. Duration of response as assessed by investigator (Time Frame - Baseline until PD/ death within 84 days of last tumor assessment; assessed up to 20 months):
Duration of response according to RECIST 1.1 and as per investigator's discretion is the time from when the CR/PR (whichever is first) criteria are first met until progression of disease (PD) or death due to any cause within 84 days of the last tumor assessment, whichever occurs first. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. PD is defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.

4. Objective disease control as assessed by independent review committee (Time Frame - Baseline up to 20 months):
Objective disease control will be determined according to RECIST 1.1 and as adjudicated by an Independent review committee. Objective disease control is defined as either a confirmed CR or PR, or stable disease (SD) lasting at least 12 weeks (84 days) as assessed by independent review committee. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. Stable disease (SD)=Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD is defined as at least a 20 % increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.

5. Objective disease control as assessed by investigator (Time Frame - Baseline up to 20 months):
Objective disease control will be determined according to RECIST 1.1 and as per investigator's discretion. Objective disease control is defined as either a confirmed CR or PR, or stable disease (SD) lasting at least 12 weeks (84 days) as assessed by investigator. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. Stable disease (SD)=Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD is defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.

6. Progression free survival as assessed by independent review committee (Time Frame - Baseline until PD or death within 84 days of last tumor assessment; assessed up to 20 months):
Progression free survival as assessed by independent review committee is defined as the time (in months) from the first administration of trial treatment to the date of the first documentation of PD (based on independent review) or death due to any cause within 84 days of the last tumor assessment, whichever occurs first. PD is defined as at least a 20 % increase in the sum of longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.

7. Progression free survival as assessed by investigator (Time Frame - Baseline until PD or death within 84 days of last tumor assessment; assessed up to 20 months):
Progression free survival as assessed by investigator is defined as the time (in months) from the first administration of trial treatment to the date of the first documentation of PD (as assessed by investigator) or death due to any cause within 84 days of the last tumor assessment, whichever occurs first. PD is defined as at least a 20 % increase in the sum of longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.

8. Overall survival (Time Frame - Baseline until death, assessed up to 20 months):
Overall survival is defined as the time (in months) from first trial treatment administration to the date of death.

9. Occurrence of Treatment emergent adverse event (TEAEs) and deaths (Time Frame - From the first dose of study drug administration until 33 days after the last dose of study drug administration, assessed up to 20 Months):
This outcome measure will be presented as the percentage of subjects with any (serious) adverse event (AE). Percentages are calculated using total number of subjects per treatment cohort as the denominator.

10. Percentage of subjects with of markedly abnormal clinical laboratory tests, vital signs, Electrocardiogram (ECG) and Eastern Cooperative Oncology Group Performance Status (ECOG PS) (Time Frame - Baseline up to 20 months):
This outcome measure will be presented as the percentage of subjects with markedly abnormal vital sign measurements. Percentages are calculated using total number of subjects per treatment cohort as the denominator. Abnormalities in clinical laboratory tests will be measured as hematology and coagulation, biochemistry and urinalysis. Abnormalities in Systolic blood pressure, diastolic blood pressure, pulse rate, respiratory rate, body temperature as a part of vital signs; electrocardiogram (ECG) wave, body weight, and Eastern Cooperative Oncology Group (ECOG) Performance Status (PS), and clinical laboratory tests (hematology and coagulation, biochemistry and urinalysis) will be assessed.

11. European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) (Time Frame - Baseline up to 20 months)

12. European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) (Time Frame - Baseline up to 20 months)

13. EuroQol Five Dimension Five Level Scale (EQ5D5L) (Time Frame - Baseline up to 20 months)

14. Plasma concentrations of the drug (Time Frame - pre-dose, at 1.5 hours post-dose and at 4 hours post-dose on Cycle 1, Day 1 and on Cycle 2, Day 1)

15. Number of subjects with markedly abnormal clinical laboratory tests (hematology and coagulation, biochemistry and urinalysis). (Time Frame - Baseline up to 20 months)

Geprüfte Regime

  • Tepotinib:
    Subjects will receive 500 milligram (mg) of tepotinib once daily in cycles of 21-day duration until disease progression, death, adverse event (AE) leading to discontinuation or withdrawal of consent.

Quelle: ClinicalTrials.gov


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Wir sehnen uns nach Sonne – unsere Haut nach Schutz

Wir sehnen uns nach Sonne – unsere Haut nach Schutz
magdal3na / Fotolia.com

Endlich Frühling! Ob auf dem Balkon, beim Spaziergang oder Joggen „mit Abstand" – die Sehnsucht nach Sonne und frischer Luft war selten so groß wie in diesen Tagen. „Genießen Sie Ihre mit Bedacht gewählten Aufenthalte im Freien und tanken Sie Energie", sagt Gerd Nettekoven, Vorstandsvorsitzender der Deutschen Krebshilfe. „Achten Sie jedoch auch auf Ihre Haut. Sie ist nach den Wintermonaten noch nicht an die UV-Strahlung der Sonne...

Hufeland-Preis ehrt Initiatoren eines bundesweiten Kita-Sonnenschutzprojekts zur Krebsprävention

Hufeland-Preis ehrt Initiatoren eines bundesweiten Kita-Sonnenschutzprojekts zur Krebsprävention
© drubig-photo / Fotolia.com

Prof. Eckhard Breitbart, Vorsitzender der Arbeitsgemeinschaft für Dermatologische Prävention e.V. (ADP), Dr. Nadja Seidel und Dr. Friederike Stölzel, Leiterinnen des Präventionszentrums des Nationalen Centrums für Tumorerkrankungen Dresden (NCT/UCC) sind mit dem Hufeland-Preis des Kuratoriums der Stiftung Hufeland-Preis ausgezeichnet worden. Sie erhielten den mit 20.000 Euro dotierten Preis für Präventivmedizin für ihr bundesweites Sonnenschutz-Projekt...