Phase
Condition
Precancerous Condition
Astrocytoma
Neurofibromatosis
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 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 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
CABA, Buenos Aires 3435907 C1428AQK
ArgentinaSite Not Available
Novartis Investigative Site
Darlinghurst, New South Wales 2010
AustraliaSite Not Available
Novartis Investigative Site
Darlinghurst 2169378, New South Wales 2155400 2010
AustraliaSite Not Available
Novartis Investigative Site
Parkville, Victoria 3052
AustraliaSite Not Available
Novartis Investigative Site
Parkville 2153770, Victoria 2145234 3052
AustraliaSite Not Available
Novartis Investigative Site
Brussels 2800866, 1200
BelgiumSite 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 04829-310
BrazilSite Not Available
Novartis Investigative Site
Barretos 3470451, São Paulo 3448433 14784 400
BrazilSite Not Available
Novartis Investigative Site
São Paulo 3448439, São Paulo 3448433 08270-070
BrazilSite Not Available
Novartis Investigative Site
Vancouver, British Columbia V6H 3V4
CanadaSite Not Available
Novartis Investigative Site
Vancouver 6173331, British Columbia 5909050 V6H 3V4
CanadaSite Not Available
Novartis Investigative Site
Toronto, Ontario M5G 1X8
CanadaSite Not Available
Novartis Investigative Site
Toronto 6167865, Ontario 6093943 M5G 1X8
CanadaSite Not Available
Novartis Investigative Site
Montreal, Quebec H3T 1C5
CanadaSite Not Available
Novartis Investigative Site
Montreal 6077243, Quebec 6115047 H3T 1C5
CanadaSite Not Available
Novartis Investigative Site
Brno, 613 00
CzechiaSite Not Available
Novartis Investigative Site
Brno 3078610, 625 00
CzechiaSite Not Available
Novartis Investigative Site
Brno Bohunice, 625 00
CzechiaSite Not Available
Novartis Investigative Site
Prague 3067696, 150 06
CzechiaSite Not Available
Novartis Investigative Site
Praha, 150 06
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
Copenhagen 2618425, DK-2100
DenmarkSite Not Available
Novartis Investigative Site
Tampere, 33521
FinlandSite Not Available
Novartis Investigative Site
Tampere 634963, 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
Brest 3030300, 29609
FranceSite Not Available
Novartis Investigative Site
Marseille, 13885
FranceSite Not Available
Novartis Investigative Site
Marseille 2995469, 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
Paris 2988507, 75231
FranceSite Not Available
Novartis Investigative Site
Rennes, 35000
FranceSite Not Available
Novartis Investigative Site
Rennes 2983990, 35033
FranceSite Not Available
Novartis Investigative Site
Vandoeuvre Les Nancy, 54511
FranceSite Not Available
Novartis Investigative Site
Vandœuvre-lès-Nancy 2970797, 54511
FranceSite Not Available
Novartis Investigative Site
Villejuif, 94800
FranceSite Not Available
Novartis Investigative Site
Villejuif 2968705, 94800
FranceSite Not Available
Novartis Investigative Site
Villejuif Cedex, 94800
FranceSite Not Available
Novartis Investigative Site
Cologne 2886242, North Rhine-Westphalia 2861876 50937
GermanySite Not Available
Novartis Investigative Site
Augsburg, 86179
GermanySite Not Available
Novartis Investigative Site
Augsburg 2954172, 86179
GermanySite Not Available
Novartis Investigative Site
Berlin, 13353
GermanySite Not Available
Novartis Investigative Site
Berlin 2950159, 13353
GermanySite Not Available
Novartis Investigative Site
Essen, 45147
GermanySite Not Available
Novartis Investigative Site
Essen 2928810, 45147
GermanySite Not Available
Novartis Investigative Site
Hamburg, 20246
GermanySite Not Available
Novartis Investigative Site
Hamburg 2911298, 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, 4920235
IsraelSite Not Available
Novartis Investigative Site
Petah Tikva 293918, 4920235
IsraelSite Not Available
Novartis Investigative Site
Firenze, FI 50139
ItalySite Not Available
Novartis Investigative Site
Florence 3176959, FI 50139
ItalySite Not Available
Novartis Investigative Site
Genova, GE 16147
ItalySite Not Available
Novartis Investigative Site
Genova 8969657, GE 16147
ItalySite Not Available
Novartis Investigative Site
Milan 6951411, MI 20133
ItalySite Not Available
Novartis Investigative Site
Milano, MI 20133
ItalySite Not Available
Novartis Investigative Site
Roma, RM 00165
ItalySite Not Available
Novartis Investigative Site
Roma 8957247, RM 00165
ItalySite Not Available
Novartis Investigative Site
Torino, TO 10126
ItalySite Not Available
Novartis Investigative Site
Torino 8980539, TO 10126
ItalySite Not Available
Novartis Investigative Site
Setagaya-ku, Tokyo 1850144 1578535
JapanSite Not Available
Novartis Investigative Site
Osaka, 534-0021
JapanSite Not Available
Novartis Investigative Site
Osaka 1853909, 5340021
JapanSite Not Available
Novartis Investigative Site
Utrecht, CS 3584
NetherlandsSite Not Available
Novartis Investigative Site
Utrecht 2745912, 3584 CS
NetherlandsSite Not Available
Novartis Investigative Site
Moscow 524901, 117198
RussiaSite Not Available
Novartis Investigative Site
Moscow, 117198
Russian FederationSite Not Available
Novartis Investigative Site
Madrid, 28009
SpainSite Not Available
Novartis Investigative Site
Madrid 3117735, 28009
SpainSite Not Available
Novartis Investigative Site
Valencia, 46026
SpainSite Not Available
Novartis Investigative Site
Valencia 2509954, 46026
SpainSite Not Available
Novartis Investigative Site
Stockholm, 17176
SwedenSite Not Available
Novartis Investigative Site
Stockholm 2673730, 17176
SwedenSite Not Available
Novartis Investigative Site
Sutton, Surrey SM2 5PT
United KingdomSite Not Available
Novartis Investigative Site
Sutton 2636503, Surrey SM2 5PT
United KingdomSite Not Available
Novartis Investigative Site
Liverpool, L12 2AP
United KingdomSite Not Available
Novartis Investigative Site
Liverpool 2644210, L12 2AP
United KingdomSite Not Available
Novartis Investigative Site
London, NW1 2BU
United KingdomSite Not Available
Novartis Investigative Site
London 2643743, 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
Phoenix Children s Hospital
Phoenix 5308655, Arizona 5551752 85016
United StatesSite Not Available
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
Childrens National Hospital
Washington D.C. 4140963, District of Columbia 4138106 20010
United StatesSite Not Available
Nicklaus Childrens Hospital
Miami, Florida 33155
United StatesSite Not Available
Nicklaus Childrens Hospital
Miami 4164138, Florida 4155751 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
Indiana Uni School of Medicine
Indianapolis 4259418, Indiana 4921868 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
Johns Hopkins Hospital
Baltimore 4347778, Maryland 4361885 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
Dana Farber Cancer Institute
Boston 4930956, Massachusetts 6254926 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
University of Minnesota
Minneapolis 5037649, Minnesota 5037779 55455
United StatesSite Not Available
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United StatesSite Not Available
Memorial Sloan Kettering Cancer Ctr
New York, New York 10065
United StatesSite Not Available
Memorial Sloan Kettering Cancer Center
New York 5128581, New York 5128638 10065
United StatesSite Not Available
Memorial Sloan Kettering Cancer Ctr
New York 5128581, New York 5128638 10065
United StatesSite Not Available
Cinn Children Hosp Medical Center
Cincinnati, Ohio 45229-3039
United StatesSite Not Available
Cinn Children Hosp Medical Center
Cincinnati 4508722, Ohio 5165418 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
St Jude Childrens Research Hospital
Memphis 4641239, Tennessee 4662168 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
Texas Childrens Hospital
Houston 4699066, Texas 4736286 77030
United StatesSite Not Available

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.