JOURNAL ONKOLOGIE – STUDIE

CINC424A2X01B Rollover Protocol

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

Rekrutierend

Studienbeginn:
März 2015

Letztes Update:
25.03.2024

Wirkstoff:
Ruxolitinib, Panobinostat

Indikation (Clinical Trials):
Polycythemia Vera, Primary Myelofibrosis, Polycythemia, Graft vs Host Disease, Leukemia, Myeloid, Leukemia, Myeloid, Acute, Thalassemia

Geschlecht:
Alle

Altersgruppe:
Alle

Phase:
Phase 4

Sponsor:
Novartis Pharmaceuticals

Collaborator:
-

Studienleiter

Novartis Pharmaceuticals
Study Director
Novartis Pharmaceuticals

Kontakt

Novartis Pharmaceuticals
Kontakt:
Phone: +41613241111
» Kontaktdaten anzeigen

Novartis Pharmaceuticals
Kontakt:
Phone: +81337978748
» Kontaktdaten anzeigen

Studienlocations
(3 von 98)

Novartis Investigative Site
52074 Aachen
GermanyAktiv, nicht rekrutierend» Google-Maps

Novartis Investigative Site
01307 Dresden
(Sachsen)
GermanyAbgeschlossen» Google-Maps

Novartis Investigative Site
20246 Hamburg
(Hamburg)
GermanyAbgeschlossen» Google-Maps

Novartis Investigative Site
39120 Magdeburg
(Sachsen-Anhalt)
GermanyAktiv, nicht rekrutierend» Google-Maps

Novartis Investigative Site
55131 Mainz
(Rheinland-Pfalz)
GermanyAktiv, nicht rekrutierend» Google-Maps

Novartis Investigative Site
89081 Ulm
(Baden-Württemberg)
GermanyAbgeschlossen» Google-Maps

Novartis Investigative Site
2010 Darlinghurst
AustraliaAbgeschlossen» Google-Maps

Novartis Investigative Site
2065 St Leonards
AustraliaAbgeschlossen» Google-Maps

Novartis Investigative Site
4029 Herston
AustraliaAbgeschlossen» Google-Maps

Novartis Investigative Site
4102 Wooloongabba
AustraliaAbgeschlossen» Google-Maps

Novartis Investigative Site
5041 Bedford Park
AustraliaAbgeschlossen» Google-Maps

Novartis Investigative Site
3128 Box Hill
AustraliaAbgeschlossen» Google-Maps

Novartis Investigative Site
3168 Clayton
AustraliaAbgeschlossen» Google-Maps

Novartis Investigative Site
3199 Franston
AustraliaAbgeschlossen» Google-Maps

Novartis Investigative Site
6000 Perth
AustraliaAbgeschlossen» Google-Maps

Novartis Investigative Site
2020 Antwerpen
BelgiumAbgeschlossen» Google-Maps

Novartis Investigative Site
8000 Brugge
BelgiumAbgeschlossen» Google-Maps

Novartis Investigative Site
3000 Leuven
BelgiumAbgeschlossen» Google-Maps

Novartis Investigative Site
4000 Liege
BelgiumAbgeschlossen» Google-Maps

Novartis Investigative Site
5800 Pleven
BulgariaAbgeschlossen» Google-Maps

Novartis Investigative Site
4002 Plovdiv
BulgariaAbgeschlossen» Google-Maps

Novartis Investigative Site
1413 Sofia
BulgariaAbgeschlossen» Google-Maps

Novartis Investigative Site
1431 Sofia
BulgariaAbgeschlossen» Google-Maps

Novartis Investigative Site
7500922 Santiago
ChileAbgeschlossen» Google-Maps

Novartis Investigative Site
2540364 Vina del Mar
ChileAbgeschlossen» Google-Maps

Novartis Investigative Site
8420383 Santiago
ChileAbgeschlossen» Google-Maps

Novartis Investigative Site
310003 Hangzhou
ChinaAbgeschlossen» Google-Maps

Novartis Investigative Site
100730 Beijing
ChinaAktiv, nicht rekrutierend» Google-Maps

Novartis Investigative Site
DK-2100 Copenhagen
DenmarkZurückgezogen» Google-Maps

Novartis Investigative Site
75475 Paris 10
FranceAbgeschlossen» Google-Maps

Novartis Investigative Site
115 27 Athens
GreeceAbgeschlossen» Google-Maps

Novartis Investigative Site
265 00 Patras
GreeceAbgeschlossen» Google-Maps

Novartis Investigative Site
1097 Budapest
HungaryAbgeschlossen» Google-Maps

Novartis Investigative Site
4032 Debrecen
HungaryAbgeschlossen» Google-Maps

Novartis Investigative Site
7400 Kaposvar
HungaryAbgeschlossen» Google-Maps

Novartis Investigative Site
6001 Kecskemet
HungaryAbgeschlossen» Google-Maps

Novartis Investigative Site
H 6725 Szeged
HungaryAbgeschlossen» Google-Maps

Novartis Investigative Site
9700 Szombathely
HungaryAbgeschlossen» Google-Maps

Novartis Investigative Site
411004 Pune
IndiaAktiv, nicht rekrutierend» Google-Maps

Novartis Investigative Site
1834111 Afula
IsraelAbgeschlossen» Google-Maps

Novartis Investigative Site
9112001 Jerusalem
IsraelAbgeschlossen» Google-Maps

Novartis Investigative Site
60126 Ancona
ItalyAbgeschlossen» Google-Maps

Novartis Investigative Site
70124 Bari
ItalyAbgeschlossen» Google-Maps

Novartis Investigative Site
40138 Bologna
ItalyAbgeschlossen» Google-Maps

Novartis Investigative Site
25123 Brescia
ItalyAktiv, nicht rekrutierend» Google-Maps

Novartis Investigative Site
71013 San Giovanni Rotondo
ItalyAktiv, nicht rekrutierend» Google-Maps

Novartis Investigative Site
50134 Firenze
ItalyAktiv, nicht rekrutierend» Google-Maps

Novartis Investigative Site
20122 Milano
ItalyAbgeschlossen» Google-Maps

Novartis Investigative Site
20132 Milano
ItalyAktiv, nicht rekrutierend» Google-Maps

Novartis Investigative Site
20162 Milano
ItalyAbgeschlossen» Google-Maps

Novartis Investigative Site
20089 Rozzano
ItalyAbgeschlossen» Google-Maps

Novartis Investigative Site
90146 Palermo
ItalyAbgeschlossen» Google-Maps

Novartis Investigative Site
27100 Pavia
ItalyAktiv, nicht rekrutierend» Google-Maps

Novartis Investigative Site
89124 Reggio Calabria
ItalyAktiv, nicht rekrutierend» Google-Maps

Novartis Investigative Site
00161 Roma
ItalyAbgeschlossen» Google-Maps

Novartis Investigative Site
00165 Roma
ItalyRekrutierend» Google-Maps

Novartis Investigative Site
10043 Orbassano
ItalyAbgeschlossen» Google-Maps

Novartis Investigative Site
21100 Varese
ItalyAktiv, nicht rekrutierend» Google-Maps

Novartis Investigative Site
80131 Napoli
ItalyAbgeschlossen» Google-Maps

Novartis Investigative Site
453-8511 Nagoya
JapanAbgeschlossen» Google-Maps

Novartis Investigative Site
466 8560 Nagoya
JapanRekrutierend» Google-Maps

Novartis Investigative Site
812-8582 Fukuoka city
JapanAbgeschlossen» Google-Maps

Novartis Investigative Site
060 8648 Sapporo city
JapanAbgeschlossen» Google-Maps

Novartis Investigative Site
259-1193 Isehara
JapanAbgeschlossen» Google-Maps

Novartis Investigative Site
565 0871 Suita
JapanAbgeschlossen» Google-Maps

Novartis Investigative Site
113-8677 Bunkyo ku
JapanAbgeschlossen» Google-Maps

Novartis Investigative Site
545-8586 Osaka
JapanAbgeschlossen» Google-Maps

Novartis Investigative Site
06591 Seoul
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps

Novartis Investigative Site
03080 Seoul
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps

Novartis Investigative Site
03080 Seoul
Korea, Republic ofRekrutierend» Google-Maps

Novartis Investigative Site
03722 Seoul
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps

Novartis Investigative Site
1107 2020 Beirut
LebanonAbgeschlossen» Google-Maps

Novartis Investigative Site
64718 Monterrey
MexicoAbgeschlossen» Google-Maps

Novartis Investigative Site
44-101 Gliwice
PolandAktiv, nicht rekrutierend» Google-Maps

Novartis Investigative Site
50 367 Wroclaw
PolandAktiv, nicht rekrutierend» Google-Maps

Novartis Investigative Site
1099 023 Lisboa
PortugalAbgeschlossen» Google-Maps

Novartis Investigative Site
1649-035 Lisboa
PortugalAbgeschlossen» Google-Maps

Novartis Investigative Site
125167 Moscow
Russian FederationAbgeschlossen» Google-Maps

Novartis Investigative Site
129110 Moscow
Russian FederationAbgeschlossen» Google-Maps

Novartis Investigative Site
185019 Petrozavodsk
Russian FederationAbgeschlossen» Google-Maps

Novartis Investigative Site
197022 Saint Petersburg
Russian FederationAktiv, nicht rekrutierend» Google-Maps

Novartis Investigative Site
833 40 Bratislava
SlovakiaZurückgezogen» Google-Maps

Novartis Investigative Site
2013 Soweto
South AfricaAbgeschlossen» Google-Maps

Novartis Investigative Site
7800 Cape Town
South AfricaAktiv, nicht rekrutierend» Google-Maps

Novartis Investigative Site
0027 Pretoria
South AfricaAbgeschlossen» Google-Maps

Novartis Investigative Site
0044 Pretoria
South AfricaAktiv, nicht rekrutierend» Google-Maps

Novartis Investigative Site
37007 Salamanca
SpainAbgeschlossen» Google-Maps

Novartis Investigative Site
08003 Barcelona
SpainAbgeschlossen» Google-Maps

Novartis Investigative Site
31008 Pamplona
SpainAbgeschlossen» Google-Maps

Novartis Investigative Site
SE-14186 Huddinge
SwedenAktiv, nicht rekrutierend» Google-Maps

Novartis Investigative Site
SE 971 80 Lulea
SwedenAktiv, nicht rekrutierend» Google-Maps

Novartis Investigative Site
SE-221 85 Lund
SwedenAktiv, nicht rekrutierend» Google-Maps

Novartis Investigative Site
451 80 Uddevalla
SwedenAktiv, nicht rekrutierend» Google-Maps

Novartis Investigative Site
10700 Bangkok
ThailandAbgeschlossen» Google-Maps

Novartis Investigative Site
06100 Ankara
TurkeyAbgeschlossen» Google-Maps

Novartis Investigative Site
34093 Istanbul
TurkeyAbgeschlossen» Google-Maps

Novartis Investigative Site
35040 Izmir
TurkeyAbgeschlossen» Google-Maps

Novartis Investigative Site
38039 Talas / Kayseri
TurkeyAbgeschlossen» Google-Maps

Alle anzeigen

Studien-Informationen

Detailed Description:

This roll-over protocol allows patients from multiple protocols, who are still receiving

clinical benefit, to continue their treatment in one study that covers multiple indications.

The population for the roll-over study should be consistent with the population defined in

the parent studies. The primary eligibility criteria for a patient to enter the roll-over

protocol is the participation and completion of a Novartis or Incyte study with ruxolitinib

monotherapy or combination of ruxolitinib and panobinostat. Efficacy parameters will not be

measured; however safety data and an evaluation of clinical benefit will be collected.

Ein-/Ausschlusskriterien

Key Inclusion criteria:

1. Patient is currently enrolled in a Novartis GDD or GMA-sponsored or Incyte-sponsored

clinical study, are receiving either ruxolitinib or combination of ruxolitinib and

panobinostat, and fulfilled all of the requirements of the parent protocol.

2. Patient is currently benefiting from the treatment with ruxolitinib monotherapy or

combination of ruxolitinib and panobinostat, as determined by the investigator

3. Patient has demonstrated compliance, as assessed by the investigator, with the parent

study protocol requirements

4. Patient currently has no evidence of progressive disease, as determined by the

investigator, following previous treatment with ruxolitinib or combination of

ruxolitinib and panobinostat

Key Exclusion criteria:

1. Patient has been permanently discontinued from study treatment in the parent study due

to any reason.

2. Patient's indication is currently approved and reimbursed in the corresponding country

for ruxolitinib monotherapy or combination of ruxolitinib and panobinostat.

3. Pregnant or nursing (lactating) women.

4. Female patients of childbearing potential (e.g. are menstruating) who do not agree to

abstinence or, if sexually active, do not agree to the use of highly effective

contraception, throughout the study and for up to 30 days after stopping study

treatment.

Other protocol-defined Inclusion / Exclusion criteria may apply.

Studien-Rationale

Primary outcome:

1. Incidence and severity of AEs and SAEs (Time Frame - 12 years):
The incidence of treatment-emergent AEs and SAEs (new or worsening from baseline) will be summarized by system organ class and/or preferred term, severity (based on CTCAE grades).

Secondary outcome:

1. Proportion of participants with clinical benefit as assessed by the investigator at scheduled visits. (Time Frame - 12 years):
The analysis of clinical benefit will be descriptive only and cannot be compared to efficacy results of other studies. In addition, as clinical benefit was only added in protocol amendment 1, it may not be available for all participants.

2. Incidence and severity of AEs and SAEs by treatment group (Time Frame - 12 years):
AEs and SAEs for participants in the Safety group will be listed and summarized by treatment group (ruxolitinib monotherapy / ruxolitinib + panobinostat combination)

Studien-Arme

Experimental: ruxolitinib monotherapy
ruxolitinib monotherapy. Patients are to use the study treatment based on the parent protocol.
Experimental: combination of ruxolitinib + panobinostat
combination of ruxolitinib and panobinostat. Patients are to use the study treatment based on the parent protocol.

Geprüfte Regime

ruxolitinib (INC424 / Jakavi / ):
ruxolitinib tablets or pediatric oral solution - participants continue ruxolitinib as they received in parent study
panobinostat (LBH589 / Farydak / ):
panobinostat capsules - participants to continue receiving panobinostat in combination with ruxolitinib as per the parent study

Quelle: ClinicalTrials.gov

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