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Kinase Inhibitor

Dabrafenib + Trametinib for Brain Tumors

Phase 4
Waitlist Available
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
Must not have
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 has participated in a combination trial where dabrafenib and/or trametinib was dispensed in combination with another study medication
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to approximately 7 years
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group

Summary

This trial is studying the effects of two cancer medications, dabrafenib and trametinib, in children. These drugs work by stopping signals that make cancer cells grow. Dabrafenib and trametinib have shown benefits in various BRAF-mutant tumors, including melanoma, lung cancer, and thyroid cancer. The goal is to see how these treatments affect children over time.

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.
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.
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 below
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I have participated in a Novartis study like CTMT212X2101.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My medication (dabrafenib/trametinib) is approved and paid for in my country.
Select...
I have been part of a study where I received dabrafenib and/or trametinib with another drug.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to approximately 7 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to approximately 7 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of participants with Adverse Events and Serious Adverse Events (SAEs)
Secondary study objectives
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 more

Side effects data

From 2016 Phase 2 trial • 12 Patients • NCT01928940
67%
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%
Leukopenia
17%
Mitral valve incompetence
17%
Deafness neurosensory
17%
Blood glucose increased
17%
Platelet count decreased
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

Awards & Highlights

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.

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
2018
Completed Phase 2
~260

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Astrocytoma, particularly those involving targeted therapies like Dabrafenib (a BRAF inhibitor) and Trametinib (a MEK inhibitor), work by blocking specific proteins involved in cell growth and division. Dabrafenib inhibits the BRAF protein, while Trametinib targets the MEK protein, both of which are part of the same signaling pathway. By disrupting this pathway, these drugs can effectively slow down or halt the proliferation of cancer cells. This targeted approach is crucial for Astrocytoma patients with BRAF mutations, offering a more personalized and potentially more effective treatment compared to conventional chemotherapy.
Imposing Phase II and Phase III Clinical Trials of Targeted Drugs for Glioblastoma: Current Status and Progress.Multiple lesions in receptor tyrosine kinase pathway determine glioblastoma response to pan-ERBB inhibitor PF-00299804 and PI3K/mTOR dual inhibitor PF-05212384.Targeting Ras-RAF-ERK and its interactive pathways as a novel therapy for malignant gliomas.

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,913 Previous Clinical Trials
4,252,997 Total Patients Enrolled
5 Trials studying Astrocytoma
652 Patients Enrolled for Astrocytoma

Media Library

Dabrafenib (Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03975829 — Phase 4
Astrocytoma Research Study Groups: Dabrafenib and/or trametinib
Astrocytoma Clinical Trial 2023: Dabrafenib Highlights & Side Effects. Trial Name: NCT03975829 — Phase 4
Dabrafenib (Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03975829 — Phase 4
~36 spots leftby May 2026