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JOURNAL ONKOLOGIE – STUDIE

Pediatric Long-Term Follow-up and Rollover Study

Rekrutierend

NCT-Nummer:
NCT03975829

Studienbeginn:
November 2019

Letztes Update:
28.02.2024

Wirkstoff:
Dabrafenib, Trametinib

Indikation (Clinical Trials):
Glioblastoma, Glioma, Astrocytoma, Neurofibromatoses, Neurofibromatosis 1, Oligodendroglioma, Ganglioglioma, Neurocytoma, Ganglioneuroma

Geschlecht:
Alle

Altersgruppe:
Alle

Phase:
Phase 4

Sponsor:
Novartis Pharmaceuticals

Collaborator:
-

Studienleiter

Novartis Pharmaceuticals
Study Director
Novartis Pharmaceuticals

Kontakt

Studienlocations
(3 von 52)

Novartis Investigative Site
86179 Augsburg
(Bayern)
GermanyAktiv, nicht rekrutierend» Google-Maps
Novartis Investigative Site
13353 Berlin
(Berlin)
GermanyAktiv, nicht rekrutierend» Google-Maps
Novartis Investigative Site
45147 Essen
(Nordrhein-Westfalen)
GermanyAktiv, nicht rekrutierend» Google-Maps
Novartis Investigative Site
20246 Hamburg
(Hamburg)
GermanyAktiv, nicht rekrutierend» Google-Maps
Novartis Investigative Site
50937 Koeln
(Nordrhein-Westfalen)
GermanyAktiv, nicht rekrutierend» Google-Maps
Phoenix Children's Hospital .
85016 Phoenix
United StatesAktiv, nicht rekrutierend» Google-Maps
Childrens National Hospital CQTI571A2306
20010 Washington
United StatesAktiv, nicht rekrutierend» Google-Maps
Nicklaus Childrens Hospital
33155 Miami
United StatesAktiv, nicht rekrutierend» Google-Maps
Indiana University School of Medicine .
46202-2810 Indianapolis
United StatesAktiv, nicht rekrutierend» Google-Maps
Johns Hopkins University IDS Pharmacy
21287 Baltimore
United StatesAktiv, nicht rekrutierend» Google-Maps
Dana Farber Cancer Institute .
02215 Boston
United StatesAktiv, nicht rekrutierend» Google-Maps
University of Minnesota .
55455 Minneapolis
United StatesAktiv, nicht rekrutierend» Google-Maps
Cinn Children Hosp Medical Center
45229-3039 Cincinnati
United StatesAktiv, nicht rekrutierend» Google-Maps
St Jude Children's Research Hospital .
38105 Memphis
United StatesAktiv, nicht rekrutierend» Google-Maps
Texas Children's Hospital
77030 Houston
United StatesAktiv, nicht rekrutierend» Google-Maps
Novartis Investigative Site
C1428AQK Caba
ArgentinaAktiv, nicht rekrutierend» Google-Maps
Novartis Investigative Site
2010 Darlinghurst
AustraliaAktiv, nicht rekrutierend» Google-Maps
Novartis Investigative Site
3052 Parkville
AustraliaAktiv, nicht rekrutierend» Google-Maps
Novartis Investigative Site
1200 Bruxelles
BelgiumAktiv, nicht rekrutierend» Google-Maps
Novartis Investigative Site
14784 400 Barretos
BrazilAktiv, nicht rekrutierend» Google-Maps
Novartis Investigative Site
04829-310 Sao Paulo
BrazilAktiv, nicht rekrutierend» Google-Maps
Novartis Investigative Site
08270-070 Sao Paulo
BrazilAbgeschlossen» Google-Maps
Novartis Investigative Site
V6H 3V4 Vancouver
CanadaAktiv, nicht rekrutierend» Google-Maps
Novartis Investigative Site
M5G 1X8 Toronto
CanadaAktiv, nicht rekrutierend» Google-Maps
Novartis Investigative Site
H3T 1C5 Montreal
CanadaAktiv, nicht rekrutierend» Google-Maps
Novartis Investigative Site
613 00 Brno
CzechiaAktiv, nicht rekrutierend» Google-Maps
Novartis Investigative Site
150 06 Praha 5
CzechiaAktiv, nicht rekrutierend» Google-Maps
Novartis Investigative Site
DK-2100 Copenhagen
DenmarkAktiv, nicht rekrutierend» Google-Maps
Novartis Investigative Site
33521 Tampere
FinlandAktiv, nicht rekrutierend» Google-Maps
Novartis Investigative Site
35203 Rennes
FranceAktiv, nicht rekrutierend» Google-Maps
Novartis Investigative Site
29609 Brest Cedex
FranceZurückgezogen» Google-Maps
Novartis Investigative Site
13885 Marseille Cedex 05
FranceAbgeschlossen» Google-Maps
Novartis Investigative Site
75231 Paris
FranceAktiv, nicht rekrutierend» Google-Maps
Novartis Investigative Site
54511 Vandoeuvre Les Nancy
FranceAktiv, nicht rekrutierend» Google-Maps
Novartis Investigative Site
94800 Villejuif
FranceAktiv, nicht rekrutierend» Google-Maps
Novartis Investigative Site
49202 Petach-Tikva
IsraelAktiv, nicht rekrutierend» Google-Maps
Novartis Investigative Site
50139 Firenze
ItalyAktiv, nicht rekrutierend» Google-Maps
Novartis Investigative Site
16147 Genova
ItalyAktiv, nicht rekrutierend» Google-Maps
Novartis Investigative Site
20133 Milano
ItalyAktiv, nicht rekrutierend» Google-Maps
Novartis Investigative Site
00165 Roma
ItalyAktiv, nicht rekrutierend» Google-Maps
Novartis Investigative Site
10126 Torino
ItalyAktiv, nicht rekrutierend» Google-Maps
Novartis Investigative Site
157-8535 Setagaya-ku
JapanAktiv, nicht rekrutierend» Google-Maps
Novartis Investigative Site
534-0021 Osaka
JapanAktiv, nicht rekrutierend» Google-Maps
Novartis Investigative Site
3584 Utrecht
NetherlandsAktiv, nicht rekrutierend» Google-Maps
Novartis Investigative Site
117198 Moscow
Russian FederationAktiv, nicht rekrutierend» Google-Maps
Novartis Investigative Site
28009 Madrid
SpainAktiv, nicht rekrutierend» Google-Maps
Novartis Investigative Site
46026 Valencia
SpainAktiv, nicht rekrutierend» Google-Maps
Novartis Investigative Site
17176 Stockholm
SwedenAktiv, nicht rekrutierend» Google-Maps
Novartis Investigative Site
SM2 5PT Sutton
United KingdomAktiv, nicht rekrutierend» Google-Maps
Novartis Investigative Site
L12 2AP Liverpool
United KingdomAktiv, nicht rekrutierend» Google-Maps
Novartis Investigative Site
WC1N 3JH London
United KingdomAktiv, nicht rekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Brief Summary:

A roll-over study to assess long-term effect in pediatric patients treated with dabrafenib

and/or trametinib.

Ein-/Ausschlusskriterien

Key Inclusion Criteria:

All Subjects:

- Written informed consent, according to local guidelines, signed by the subjects and/or

by the parents or legal guardian prior to any study related screening procedures are

performed.

- Participation in a Novartis sponsored study such as CTMT212X2101, CDRB436G2201,

CDRB436A2102, regardless of current age.

- Parent study (or cohort of parent study) is planned to be closed.

- Subject has demonstrated compliance, as assessed by the investigator, within the

parent study protocol requirement(s).

- Willingness and ability to comply with scheduled visits, treatment plans and any other

study procedures.

For Subjects Entering the Treatment Period:

- Subject is currently receiving treatment with dabrafenib/trametinib monotherapy or

combination within a Novartis Sponsored Drug Development study. Note that subjects who

were on the chemotherapy arm of the CDRB436G2201 study are eligible for treatment

period of this study only after crossing over into the experimental treatment arm of

the CDRB436G2201 study

- In the opinion of the investigator is likely to benefit from continued treatment.

Key Exclusion Criteria:

All Subjects:

- Subject has participated in a combination trial where dabrafenib and/or trametinib was

dispensed in combination with another study medication.

For Subjects Entering the Treatment Period:

- Subject has permanently discontinued from study treatment in the parent protocol due

to any reason.

- Treatment with dabrafenib and/or trametinib for the subject's indication is approved

for marketing and the appropriate dosage form is commercially available and reimbursed

in the local country

- Subject currently has unresolved drug related severe toxicities for which dabrafenib

and/or trametinib dosing has been interrupted in the parent study. If the subject

should meet criteria to resume treatment on the parent protocol then they may be

eligible for treatment in this study.

Other protocol-defined inclusion/exclusion may apply.

Studien-Rationale

Primary outcome:

1. Number of participants with Adverse Events and Serious Adverse Events (SAEs) (Time Frame - Baseline up to approximately 7 years):
To assess the long-term safety of treatment with dabrafenib, trametinib or the combination.



Secondary outcome:

1. Percentage of participants with height (measured by cm or in) changes over time (Time Frame - Baseline up to approximately 7 years):
Developmental monitoring: Serial measurements of height will be collected throughout the study

2. Percentage of participants with weight (measured by kg or lb) changes over time (Time Frame - Baseline up to approximately 7 years):
Developmental monitoring: Serial measurements of weight will be collected throughout the study

3. Percentage of participants with skeletal maturation (measured by bone age on x-ray or MRI) changes over time (Time Frame - Baseline up to approximately 7 years):
Developmental monitoring: Serial measurements of skeletal maturation will be collected throughout the study

4. Percentage of participants with sexual maturation (measured by tanner staging criteria) changes over time (Time Frame - Baseline up to approximately 7 years):
Developmental monitoring: Serial measurements of sexual maturation will be collected throughout the study

5. Percentage of participants with cardiac function (measured by ECG) changes over time (Time Frame - Baseline up to approximately 7 years):
Developmental monitoring: Serial measurements of cardiac function will be collected throughout the study

6. Clinical Benefit (measured by CT/MRI) (Time Frame - Baseline up to approximately 7 years):
Disease specific clinical benefit, as determined by investigator using institutional standard of care. Investigator will measure tumor response based on the Response Assessment used for the subject in the parent protocol (Response Assessment in Neuro-Oncology (RANO) criteria for solid tumors, RECIST, NF1 Volumetric, Neuroblastoma, or LCH criteria).

Geprüfte Regime

  • dabrafenib (DRB436):
    dabrafenib oral, twice daily
  • trametinib (TMT212):
    trametinib oral, once daily

Quelle: ClinicalTrials.gov


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