Actively Recruiting
Treatment of BRAF ( B-Rapidly Accelerated Fibrosarcoma) Mutated Papillary Craniopharyngioma
Led by Eva Marie Erfurth, MD, PhD · Updated on 2024-02-14
25
Participants Needed
1
Research Sites
240 weeks
Total Duration
On this page
Sponsors
E
Eva Marie Erfurth, MD, PhD
Lead Sponsor
N
Novartis
Collaborating Sponsor
AI-Summary
What this Trial Is About
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. Progression free survival, cognition, ophthalmologic status, hypothalamic status and quality of life will be assessed 1 year after initiation of study treatment
CONDITIONS
Official Title
Treatment of BRAF ( B-Rapidly Accelerated Fibrosarcoma) Mutated Papillary Craniopharyngioma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed papillary craniopharyngioma
- BRAF V600E mutation confirmed by immunohistochemistry and genetic analysis
- Newly diagnosed tumor or recurrence where radical surgery is not possible without serious or permanent side effects
- Age over 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Adequate organ function including neutrophils > 1.5 x 10^9, platelets > 100 x 10^9, creatinine less than 1.5 times upper limit of normal or creatinine clearance <45 ml/min, bilirubin less than 1.5 times upper limit of normal, ASAT/ALAT less than 2.5 times upper limit of normal
- Ability to understand and provide informed consent
- Previous cancer allowed if no current treatment is required
- Agreement to use effective contraception to avoid pregnancy
You will not qualify if you...
- Current participation in another drug or experimental treatment study
- Previous treatment with BRAF or MEK inhibitors
- Allergic reaction to study drugs
- Use of unauthorized medications, including strong CYP2C8 or CYP3A4 inducers, unless stopped 14 days before study entry
- Known severe cardiovascular disease making MEK inhibitor treatment unsafe (e.g., severe heart failure, QT prolongation, uncontrolled arrhythmia, recent heart attack within 6 months, uncontrolled hypertension)
- Active bleeding or intracranial hemorrhage within 4 weeks before study
- Thromboembolic disease within 6 months and unstable blood thinning treatment less than 4 weeks before study
- Pregnancy or breastfeeding
- Previous central serous retinopathy or retinal vein occlusion
- Uveitis or iritis within 4 weeks before study
- Surgery within 3 weeks before study
- For postoperative patients, radiation therapy within 3 months before study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Department of Endocrinology
Lund, Sweden, 22185
Actively Recruiting
Research Team
E
Eva Marie Erfurth, MD. PhD.
CONTACT
S
Sara Kinhult, MD. PhD.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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