What side effects are associated with this type of intervention?

Common treatments for Astrocytoma, particularly those involving BRAF inhibitors like Dabrafenib and MEK inhibitors like Trametinib, often have side effects such as fever, fatigue, nausea, vomiting, diarrhea, and skin rashes. Additionally, patients may experience more severe side effects including liver enzyme abnormalities, hypertension, and cardiomyopathy. It is important for patients to discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

The FDA has approved the combination of Dabrafenib (a BRAF inhibitor) and Trametinib (a MEK inhibitor) for the treatment of BRAF V600E-mutant low-grade and high-grade gliomas, which include certain types of astrocytomas. This combination has shown clinically meaningful activity in patients with these mutations, providing a targeted therapy option that disrupts the BRAF/MEK pathway involved in tumor growth.

What other types of research exist?

Promising novel alternatives for Astrocytoma patients in 2024 include: 1) Tumor-Treating Fields (TTFields) combined with Temozolomide, which has shown improved survival rates in glioblastoma patients. 2) Immunotherapy agents such as Nivolumab (PD-1 inhibitor) and Pembrolizumab (PD-1 inhibitor), which are being investigated for their efficacy in brain tumors. 3) Targeted therapies like Bevacizumab (VEGF inhibitor) and Everolimus (mTOR inhibitor), which have shown potential in treating recurrent or progressive brain tumors. 4) Novel tyrosine kinase inhibitors like Osimertinib for patients with specific genetic mutations (e.g., EGFR mutations).

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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 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

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%

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

0 / 3Eligibility criteria met

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.