Phase
Condition
Neurofibromatosis
Precancerous Condition
Cancer
Treatment
dabrafenib
trametinib
Clinical Study ID
Ages 1-99 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
All Subjects:
Written informed consent, according to local guidelines, signed by the subjectsand/or by the parents or legal guardian prior to any study related screeningprocedures 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 theparent study protocol requirement(s).
Willingness and ability to comply with scheduled visits, treatment plans and anyother study procedures.
For Subjects Entering the Treatment Period:
Subject is currently receiving treatment with dabrafenib/trametinib monotherapy orcombination within a Novartis Sponsored Drug Development study. Note that subjectswho were on the chemotherapy arm of the CDRB436G2201 study are eligible fortreatment period of this study only after crossing over into the experimentaltreatment arm of the CDRB436G2201 study
In the opinion of the investigator is likely to benefit from continued treatment.
Exclusion
Key Exclusion Criteria:
All Subjects:
- Subject has participated in a combination trial where dabrafenib and/or trametinibwas dispensed in combination with another study medication.
For Subjects Entering the Treatment Period:
Subject has permanently discontinued from study treatment in the parent protocol dueto any reason.
Treatment with dabrafenib and/or trametinib for the subject's indication is approvedfor marketing and the appropriate dosage form is commercially available andreimbursed in the local country
Subject currently has unresolved drug related severe toxicities for which dabrafeniband/or trametinib dosing has been interrupted in the parent study. If the subjectshould meet criteria to resume treatment on the parent protocol then they may beeligible for treatment in this study.
Other protocol-defined inclusion/exclusion may apply.
Study Design
Connect with a study center
Novartis Investigative Site
Caba, Buenos Aires C1428AQK
ArgentinaSite Not Available
Novartis Investigative Site
Darlinghurst, New South Wales 2010
AustraliaSite Not Available
Novartis Investigative Site
Parkville, Victoria 3052
AustraliaSite Not Available
Novartis Investigative Site
Bruxelles, 1200
BelgiumSite Not Available
Novartis Investigative Site
Barretos, SP 14784 400
BrazilSite Not Available
Novartis Investigative Site
Sao Paulo, SP 08270-070
BrazilSite Not Available
Novartis Investigative Site
Vancouver, British Columbia V6H 3V4
CanadaSite Not Available
Novartis Investigative Site
Toronto, Ontario M5G 1X8
CanadaSite Not Available
Novartis Investigative Site
Montreal, Quebec H3T 1C5
CanadaSite Not Available
Novartis Investigative Site
Brno, 613 00
CzechiaSite Not Available
Novartis Investigative Site
Brno Bohunice, 625 00
CzechiaSite Not Available
Novartis Investigative Site
Praha 5, 150 06
CzechiaSite Not Available
Novartis Investigative Site
Copenhagen, DK-2100
DenmarkSite Not Available
Novartis Investigative Site
Tampere, 33521
FinlandSite Not Available
Novartis Investigative Site
Brest Cedex, Finistere 29609
FranceSite Not Available
Novartis Investigative Site
Brest, 29609
FranceSite Not Available
Novartis Investigative Site
Marseille, 13885
FranceSite Not Available
Novartis Investigative Site
Marseille Cedex, 13385
FranceSite Not Available
Novartis Investigative Site
Marseille Cedex 05, 13885
FranceSite Not Available
Novartis Investigative Site
Marseille Cedex 5, 13385
FranceSite Not Available
Novartis Investigative Site
Paris, 75231
FranceSite Not Available
Novartis Investigative Site
Rennes, 35033
FranceSite Not Available
Novartis Investigative Site
Vandoeuvre Les Nancy, 54511
FranceSite Not Available
Novartis Investigative Site
Villejuif, 94800
FranceSite Not Available
Novartis Investigative Site
Villejuif Cedex, 94800
FranceSite Not Available
Novartis Investigative Site
Augsburg, 86179
GermanySite Not Available
Novartis Investigative Site
Berlin, 13353
GermanySite Not Available
Novartis Investigative Site
Essen, 45147
GermanySite Not Available
Novartis Investigative Site
Hamburg, 20246
GermanySite Not Available
Novartis Investigative Site
Koeln, 50937
GermanySite Not Available
Novartis Investigative Site
Petach Tikva, 49202
IsraelSite Not Available
Novartis Investigative Site
Petach-Tikva, 49202
IsraelSite Not Available
Novartis Investigative Site
Firenze, FI 50139
ItalySite Not Available
Novartis Investigative Site
Genova, GE 16147
ItalySite Not Available
Novartis Investigative Site
Milano, MI 20133
ItalySite Not Available
Novartis Investigative Site
Roma, RM 00165
ItalySite Not Available
Novartis Investigative Site
Torino, TO 10126
ItalySite Not Available
Novartis Investigative Site
Setagaya-ku, Tokyo 157-8535
JapanSite Not Available
Novartis Investigative Site
Osaka, 534-0021
JapanSite Not Available
Novartis Investigative Site
Utrecht, CS 3584
NetherlandsSite Not Available
Novartis Investigative Site
Moscow, 117198
Russian FederationSite Not Available
Novartis Investigative Site
Madrid, 28009
SpainSite Not Available
Novartis Investigative Site
Valencia, 46026
SpainSite Not Available
Novartis Investigative Site
Stockholm, 17176
SwedenSite Not Available
Novartis Investigative Site
Sutton, Surrey SM2 5PT
United KingdomSite Not Available
Novartis Investigative Site
Liverpool, L12 2AP
United KingdomSite Not Available
Novartis Investigative Site
London, WC1N 3JH
United KingdomSite Not Available
Phoenix Children s Hospital
Phoenix, Arizona 85016
United StatesSite Not Available
Phoenix Children s Hospital .
Phoenix, Arizona 85016
United StatesSite Not Available
Phoenix Children's Hospital .
Phoenix, Arizona 85016
United StatesSite Not Available
Phoenix Childrens Hospital
Phoenix, Arizona 85016
United StatesActive - Recruiting
Childrens National Hospital
Washington, District of Columbia 20010
United StatesSite Not Available
Childrens National Hospital CQTI571A2306
Washington, District of Columbia 20010
United StatesSite Not Available
Nicklaus Childrens Hospital
Miami, Florida 33155
United StatesSite Not Available
Indiana Uni School of Medicine
Indianapolis, Indiana 46202-2810
United StatesSite Not Available
Indiana Uni School of Medicine .
Indianapolis, Indiana 46202-2810
United StatesSite Not Available
Indiana University School of Medicine .
Indianapolis, Indiana 46202-2810
United StatesSite Not Available
Johns Hopkins Hospital
Baltimore, Maryland 21287
United StatesSite Not Available
Johns Hopkins Hospital Main Centre
Baltimore, Maryland 21287
United StatesSite Not Available
Johns Hopkins University IDS Pharmacy
Baltimore, Maryland 21287
United StatesSite Not Available
Dana Farber Cancer Institute
Boston, Massachusetts 02215
United StatesSite Not Available
Dana Farber Cancer Institute .
Boston, Massachusetts 02215
United StatesSite Not Available
University of Minnesota
Minneapolis, Minnesota 55455
United StatesSite Not Available
University of Minnesota .
Minneapolis, Minnesota 55455
United StatesSite Not Available
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United StatesSite Not Available
Cinn Children Hosp Medical Center
Cincinnati, Ohio 45229-3039
United StatesSite Not Available
St Jude Children's Research Hospital .
Memphis, Tennessee 38105
United StatesSite Not Available
St Jude Childrens Research Hospital
Memphis, Tennessee 38105
United StatesSite Not Available
St Jude Childrens Research Hospital .
Memphis, Tennessee 38105
United StatesSite Not Available
Texas Children's Hospital
Houston, Texas 77030
United StatesSite Not Available
Texas Childrens Hospital
Houston, Texas 77030
United StatesSite Not Available
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