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JOURNAL ONKOLOGIE – STUDIE

Rollover Study for Continued Safety and Tolerability in Subjects Treated With Spartalizumab Alone or in Combination With Other Study Treatments

Rekrutierend

NCT-Nummer:
NCT04058756

Studienbeginn:
Oktober 2019

Letztes Update:
26.03.2024

Wirkstoff:
PDR001

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 1

Sponsor:
Novartis Pharmaceuticals

Collaborator:
-

Studienleiter

Novartis Pharmaceuticals
Study Director
Novartis Pharmaceuticals

Kontakt

Studienlocations
(3 von 52)

Novartis Investigative Site
45147 Essen
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Novartis Investigative Site
69120 Heidelberg
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Novartis Investigative Site
07740 Jena
(Thüringen)
GermanyRekrutierend» Google-Maps
Novartis Investigative Site
89081 Ulm
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
MD Anderson Cancer Center Uni of Te MDACC
77030 Houston
United StatesRekrutierend» Google-Maps
Novartis Investigative Site
M5G 2M9 Toronto
CanadaRekrutierend» Google-Maps
Novartis Investigative Site
H3T 1E2 Montreal
CanadaRekrutierend» Google-Maps
Novartis Investigative Site
510515 Guangzhou
ChinaAbgeschlossen» Google-Maps
Novartis Investigative Site
510060 Guangzhou
ChinaRekrutierend» Google-Maps
Novartis Investigative Site
140 59 Praha 4
CzechiaZurückgezogen» Google-Maps
Novartis Investigative Site
13885 Marseille Cedex 05
FranceAktiv, nicht rekrutierend» Google-Maps
Novartis Investigative Site
13273 Marseille
FranceAbgeschlossen» Google-Maps
Novartis Investigative Site
94800 Villejuif
FranceAktiv, nicht rekrutierend» Google-Maps
Novartis Investigative Site
Shatin New Territories
Hong KongRekrutierend» Google-Maps
Novartis Investigative Site
H 1122 Budapest
HungaryRekrutierend» Google-Maps
Novartis Investigative Site
4032 Debrecen
HungaryAktiv, nicht rekrutierend» Google-Maps
Novartis Investigative Site
03080 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Novartis Investigative Site
05505 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Novartis Investigative Site
2333 ZA Leiden
NetherlandsAbgeschlossen» Google-Maps
Novartis Investigative Site
60-693 Poznan
PolandAktiv, nicht rekrutierend» Google-Maps
Novartis Investigative Site
08907 Hospitalet de LLobregat
SpainRekrutierend» Google-Maps
Novartis Investigative Site
8091 Zuerich
SwitzerlandRekrutierend» Google-Maps
Novartis Investigative Site
90110 Songkhla
ThailandAbgeschlossen» Google-Maps
Novartis Investigative Site
10310 Bangkok
ThailandAbgeschlossen» Google-Maps
Novartis Investigative Site
50200 Chiang Mai
ThailandAktiv, nicht rekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Brief Summary:

The purpose of this study is to continue to assess safety and tolerability, and to allow

continued access to study treatment for subjects already receiving spartalizumab as single

agent or in combination with other study treatments.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Subject is currently enrolled in a pre-defined Novartis-sponsored study and is

receiving spartalizumab as single agent or in combination with other study treatment,

- Subject is currently deriving clinical benefit from the study treatment, as determined

by the investigator.

Other protocol defined inclusion criteria may apply

Exclusion Criteria:

- Subject has been permanently discontinued from spartalizumab in the parent protocol

for any reason other than enrollment in the Roll over Study

- Subject does not meet the criteria specified in the parent protocol criteria for

continued study treatment.

Studien-Rationale

Primary outcome:

1. Frequency and nature of AE and SAE by subject (Time Frame - 5 years):
Safety data.

2. Number of subjects with PDR001 dose interruption and/or reduction (Time Frame - 5 years)

Secondary outcome:

1. Number of subjects receiving PDR001 (Time Frame - 5 years)

2. Subject's exposure duration (Time Frame - 5 years)

Geprüfte Regime

  • PDR001:
    PDR001

Quelle: ClinicalTrials.gov


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