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Kinase Inhibitor
Dabrafenib + Trametinib for Brain Tumors
Phase 4
Recruiting
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participation in a Novartis sponsored study such as CTMT212X2101, CDRB436G2201, CDRB436A2102, regardless of current age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to approximately 7 years
Awards & highlights
Study Summary
This trial is continuing to assess the long-term effects of the drugs dabrafenib and trametinib in children.
Who is the study for?
This trial is for pediatric patients with various brain tumors who are already participating in Novartis-sponsored studies and receiving dabrafenib/trametinib. They must have shown compliance, be likely to benefit from continued treatment, and not have severe unresolved toxicities related to the drugs. Those previously on chemotherapy can join after switching to the experimental arm.Check my eligibility
What is being tested?
The study is a long-term follow-up focusing on children treated with dabrafenib and/or trametinib for brain tumors. It aims to assess the ongoing effects of these medications over an extended period after initial trials.See study design
What are the potential side effects?
While specific side effects aren't listed here, common ones associated with dabrafenib/trametinib include fever, fatigue, skin rash, nausea, headache, joint pain and increased risk of infections. Severe toxicities may lead to discontinuation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have participated in a Novartis study like CTMT212X2101.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline up to approximately 7 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to approximately 7 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants with Adverse Events and Serious Adverse Events (SAEs)
Secondary outcome measures
Clinical Benefit (measured by CT/MRI)
Percentage of participants with cardiac function (measured by ECG) changes over time
Percentage of participants with height (measured by cm or in) changes over time
+3 moreSide effects data
From 2016 Phase 2 trial • 12 Patients • NCT0192894067%
Aspartate aminotransferase increased
67%
Pyrexia
67%
Oedema peripheral
50%
Neutropenia
50%
Stomatitis
33%
Arthralgia
33%
Nasopharyngitis
33%
Headache
33%
Hypophosphataemia
33%
Blood alkaline phosphatase increased
33%
Constipation
33%
Anaemia
17%
Platelet count decreased
17%
Mitral valve incompetence
17%
Leukopenia
17%
Blood glucose increased
17%
Deafness neurosensory
17%
Blood phosphorus decreased
17%
Blood albumin decreased
17%
Blood lactate dehydrogenase increased
17%
Blood pressure increased
17%
Ejection fraction decreased
17%
Glucose urine present
17%
White blood cell count decreased
17%
Nausea
17%
Vomiting
17%
Myalgia
17%
Pain in extremity
17%
Erythema
17%
Pneumonia bacterial
17%
Neuropathy peripheral
17%
Cough
17%
Thermal burn
17%
Diarrhoea
17%
Erythema nodosum
17%
Chills
17%
Retinal vascular disorder
17%
Bronchitis
17%
Retinal detachment
17%
Gingival bleeding
17%
Rhinitis allergic
17%
Dermatitis acneiform
17%
Lip dry
17%
Alanine aminotransferase increased
17%
Mechanical urticaria
17%
Skin fissures
17%
Malaise
17%
Uveitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase II: GSK2118436 150 mg + GSK1120212 2 mg
Phase I: GSK2118436 150 mg + GSK1120212 2 mg
Trial Design
1Treatment groups
Experimental Treatment
Group I: Dabrafenib and/or trametinibExperimental Treatment2 Interventions
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
First Studied
Drug Approval Stage
How many patients have taken this drug
dabrafenib
2016
Completed Phase 2
~60
trametinib
2012
Completed Phase 2
~200
Find a Location
Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
2,857 Previous Clinical Trials
4,197,551 Total Patients Enrolled
5 Trials studying Astrocytoma
652 Patients Enrolled for Astrocytoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am willing and able to follow the study's schedule and procedures.My medication (dabrafenib/trametinib) is approved and paid for in my country.I am currently in a Novartis study using dabrafenib/trametinib for my treatment.I have participated in a Novartis study like CTMT212X2101.I have been part of a study where I received dabrafenib and/or trametinib with another drug.I had severe side effects from dabrafenib/trametinib, stopping my treatment.The doctor thinks you will benefit from staying in the study and receiving treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Dabrafenib and/or trametinib
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there still availability for patients to join this clinical trial?
"That is correct. According to the information posted on clinicaltrials.gov, this research project was initially published on November 4th 2019 and has been recently updated as of September 30th 2022. The trial requires 250 participants spread across 10 independent sites for enrolment."
Answered by AI
Are there prior experiments that have included dabrafenib as a factor?
"At present, 95 different clinical trials are assessing the efficacy of dabrafenib. Of those active studies, 6 have advanced to Phase 3. Though Honolulu is hosting a considerable number of these investigations, there are 5805 other sites across the world participating in this research."
Answered by AI
Has dabrafenib been officially sanctioned by the FDA?
"There is an abundance of data that attest to the safety of dabrafenib, so it has been rated a 3 on our scale. This treatment is currently approved for use in medical settings."
Answered by AI
How many individuals have enrolled in this clinical experiment?
"This clinical trial necessitates the recruitment of 250 qualified participants. There are two primary enrolment sites, Children's National Hospital CQTI571A2306 in Washington D.C., and Cincinnati Children’s Hospital Medical Center in Ohio."
Answered by AI
How many geographical sites are participating in the trial?
"At present, 10 sites situated in Washington, Cincinnati, Phoenix and other cities are enrolling participants for the trial. To reduce travel burdens associated with enrollment, it is wise to select a situate close by."
Answered by AI
Who else is applying?
What state do they live in?
Texas
New York
What site did they apply to?
Memorial Sloan Kettering Cancer Center
St Jude Children's Research Hospital
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1
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