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New treatment option for Craniopharyngioma
Official title Treatment of BRAF ( B-Rapidly Accelerated Fibrosarcoma) Mutated Papillary Craniopharyngioma
ClinicalTrials.gov ID: NCT05525273
What this study is testing
What is Oral dabrafenib and trametinib?
Oral dabrafenib and trametinib is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for craniopharyngioma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Subjects with papillary craniopharyngioma harboring a BRAF mutation will be treated with a BRAF + MEK inhibitor (dabrafenib + trametinib) after informed consent. Study participants will be administered oral dabrafenib and trametinib until maximal tumor volume reduction assessed by MRI.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histologically verified papillary craniopharyngioma.
- BRAF mutated V600E (valine 600 glutamine), verified immunohistochemically and by molecular genetic analysis
- Newly diagnosed tumor, or recurrence after previous surgery, where surgery is not considered to be able to be performed radically without the risk of...
- Age over 18 years
- Functional status according to ECOG (Eastern Cooperative Oncology Group performance status) 0-2
You likely can't join if
- Ongoing treatment in another drug study or other experimental treatment.
- Previous treatment with BRAF or MEK inhibitors.
- Hypersensitivity to study drugs.
- Ongoing treatment with non-authorized drugs, (strong inducers of CYP2C8 or CYP3A4). If the patient is on unauthorized drugs, they must be...
- Known cardiovascular disease where treatment with MEK inhibitors is considered inappropriate, eg severe heart failure, prolongation of QT time...
- Active bleeding; intracranial hemorrhage last 4 weeks before inclusion.
See the full eligibility criteria
- Histologically verified papillary craniopharyngioma.
- BRAF mutated V600E (valine 600 glutamine), verified immunohistochemically and by molecular genetic analysis
- Newly diagnosed tumor, or recurrence after previous surgery, where surgery is not considered to be able to be performed radically without the risk of serious or permanent sequelae.
- Age over 18 years
- Functional status according to ECOG (Eastern Cooperative Oncology Group performance status) 0-2
- Adequate organ function: neutrophils\> 1.5 x 109 platelets\> 100 x 109 creatinine \<1.5 x ULN (upper limit of normal) or creatinine clearance \<45 ml / min bilirubin \<1.5 x ULN ASAT (aspartate aminotransferase) / ALAT...
- Ability to understand and give informed consent.
- Previous cancer, which does not require current treatment is allowed.
- The patient agrees to use an adequate method to avoid pregnancy.
- Ongoing treatment in another drug study or other experimental treatment.
- Previous treatment with BRAF or MEK inhibitors.
- Hypersensitivity to study drugs.
- Ongoing treatment with non-authorized drugs, (strong inducers of CYP2C8 or CYP3A4). If the patient is on unauthorized drugs, they must be discontinued at least 14 days before inclusion.
- Known cardiovascular disease where treatment with MEK inhibitors is considered inappropriate, eg severe heart failure, prolongation of QT time, uncontrolled arrhythmia, recent (\<6 months) cardiac infarction...
- Active bleeding; intracranial hemorrhage last 4 weeks before inclusion.
- Thromboembolic disease last 6 months and unstable anticoagulant treatment less than 4 weeks before inclusion.
- Women who are pregnant or breastfeeding.
- Previous central serous retinopathy or retinal vein occlusion.
- Previous uveitis or iritis last 4 weeks before inclusion.
- Surgery within the last 3 weeks.
- For postoperative patients; radiation therapy within the last 3 months.
The study team makes the final eligibility decision.
Where it's taking place
- Lund, Sweden
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lund, Sweden. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.