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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03975829




Registration number
NCT03975829
Ethics application status
Date submitted
30/05/2019
Date registered
5/06/2019

Titles & IDs
Public title
Pediatric Long-Term Follow-up and Rollover Study
Scientific title
An Open Label, Multi-center Roll-over Study to Assess Long-term Effect in Pediatric Patients Treated With Tafinlar (Dabrafenib) and/or Mekinist (Trametinib)
Secondary ID [1] 0 0
2018-004459-19
Secondary ID [2] 0 0
CDRB436G2401
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diffuse Astrocytoma 0 0
Anaplastic Astrocytoma 0 0
Astrocytoma 0 0
Oligodendroglioma, Childhood 0 0
Anaplastic Oligodendroglioma 0 0
Glioblastoma 0 0
Pilocytic Astrocytoma 0 0
Giant Cell Astrocytoma 0 0
Pleomorphic Xanthoastrocytoma 0 0
Anaplastic Pleomorphic Xanthoastrocytoma 0 0
Angiocentric Glioma 0 0
Chordoid Glioma of Third Ventricle 0 0
Gangliocytoma 0 0
Ganglioglioma 0 0
Anaplastic Ganglioglioma 0 0
Dysplastic Gangliocytoma of Cerebrellum 0 0
Desmoplastic Infantile Astrocytoma and Ganglioglioma 0 0
Papillary Glioneuronal Tumor 0 0
Rosette-forming Glioneuronal Tumor 0 0
Central Neurocytoma 0 0
Extraventricular Neurocytoma 0 0
Cerebellar Liponeurocytoma 0 0
Neurofibromatosis Type 1 0 0
Condition category
Condition code
Cancer 0 0 0 0
Brain
Cancer 0 0 0 0
Children's - Brain
Neurological 0 0 0 0
Other neurological disorders
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders
Skin 0 0 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - dabrafenib
Treatment: Drugs - trametinib

Experimental: Dabrafenib and/or trametinib - Patients in this study may receive one of the following treatments received in the parent study which are:

* Patients who received monotherapy of either of dabrafenib or trametinib
* Patients who received combination of dabrafenib and trametinib

* Patients who discontinued treatment on parent study are still offered to participate in long-term follow-up


Treatment: Drugs: dabrafenib
dabrafenib oral, twice daily

Treatment: Drugs: trametinib
trametinib oral, once daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with Adverse Events and Serious Adverse Events (SAEs)
Timepoint [1] 0 0
Baseline up to approximately 7 years
Secondary outcome [1] 0 0
Percentage of participants with height (measured by cm or in) changes over time
Timepoint [1] 0 0
Baseline up to approximately 7 years
Secondary outcome [2] 0 0
Percentage of participants with weight (measured by kg or lb) changes over time
Timepoint [2] 0 0
Baseline up to approximately 7 years
Secondary outcome [3] 0 0
Percentage of participants with skeletal maturation (measured by bone age on x-ray or MRI) changes over time
Timepoint [3] 0 0
Baseline up to approximately 7 years
Secondary outcome [4] 0 0
Percentage of participants with sexual maturation (measured by tanner staging criteria) changes over time
Timepoint [4] 0 0
Baseline up to approximately 7 years
Secondary outcome [5] 0 0
Percentage of participants with cardiac function (measured by ECG) changes over time
Timepoint [5] 0 0
Baseline up to approximately 7 years
Secondary outcome [6] 0 0
Clinical Benefit (measured by CT/MRI)
Timepoint [6] 0 0
Baseline up to approximately 7 years

Eligibility
Key inclusion criteria
Key

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
Minimum age
1 Year
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/11/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
29/05/2026
Actual
Sample size
Target
Accrual to date
Final
166
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Darlinghurst
Recruitment hospital [2] 0 0
Novartis Investigative Site - Parkville
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
3052 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
District of Columbia
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Indiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
Massachusetts
Country [7] 0 0
United States of America
State/province [7] 0 0
Minnesota
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
Tennessee
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
Argentina
State/province [12] 0 0
Buenos Aires
Country [13] 0 0
Belgium
State/province [13] 0 0
Bruxelles
Country [14] 0 0
Brazil
State/province [14] 0 0
SP
Country [15] 0 0
Canada
State/province [15] 0 0
British Columbia
Country [16] 0 0
Canada
State/province [16] 0 0
Ontario
Country [17] 0 0
Canada
State/province [17] 0 0
Quebec
Country [18] 0 0
Czechia
State/province [18] 0 0
Brno Bohunice
Country [19] 0 0
Czechia
State/province [19] 0 0
Praha 5
Country [20] 0 0
Denmark
State/province [20] 0 0
Copenhagen
Country [21] 0 0
Finland
State/province [21] 0 0
Tampere
Country [22] 0 0
France
State/province [22] 0 0
Bretagne
Country [23] 0 0
France
State/province [23] 0 0
Brest
Country [24] 0 0
France
State/province [24] 0 0
Marseille
Country [25] 0 0
France
State/province [25] 0 0
Paris
Country [26] 0 0
France
State/province [26] 0 0
Rennes
Country [27] 0 0
France
State/province [27] 0 0
Vandoeuvre Les Nancy
Country [28] 0 0
France
State/province [28] 0 0
Villejuif
Country [29] 0 0
Germany
State/province [29] 0 0
Augsburg
Country [30] 0 0
Germany
State/province [30] 0 0
Berlin
Country [31] 0 0
Germany
State/province [31] 0 0
Essen
Country [32] 0 0
Germany
State/province [32] 0 0
Hamburg
Country [33] 0 0
Germany
State/province [33] 0 0
Koeln
Country [34] 0 0
Israel
State/province [34] 0 0
Petach Tikva
Country [35] 0 0
Italy
State/province [35] 0 0
FI
Country [36] 0 0
Italy
State/province [36] 0 0
GE
Country [37] 0 0
Italy
State/province [37] 0 0
MI
Country [38] 0 0
Italy
State/province [38] 0 0
RM
Country [39] 0 0
Italy
State/province [39] 0 0
TO
Country [40] 0 0
Japan
State/province [40] 0 0
Tokyo
Country [41] 0 0
Japan
State/province [41] 0 0
Osaka
Country [42] 0 0
Netherlands
State/province [42] 0 0
CS
Country [43] 0 0
Russian Federation
State/province [43] 0 0
Moscow
Country [44] 0 0
Spain
State/province [44] 0 0
Madrid
Country [45] 0 0
Spain
State/province [45] 0 0
Valencia
Country [46] 0 0
Sweden
State/province [46] 0 0
Stockholm
Country [47] 0 0
United Kingdom
State/province [47] 0 0
Surrey
Country [48] 0 0
United Kingdom
State/province [48] 0 0
Liverpool
Country [49] 0 0
United Kingdom
State/province [49] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Country 0 0
Phone 0 0
1-888-669-6682
Fax 0 0
Email 0 0
novartis.email@novartis.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.clinicalstudydatarequest.com


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03975829