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Treatment of BRAF ( B-Rapidly Accelerated Fibrosarcoma) Mutated Papillary Craniopharyngioma

NCT05525273 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2024-02-14

No results posted yet for this study

Summary

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

Interventions

DRUG

Oral dabrafenib and trametinib

Neoadjuvant or postoperative treatment of patients with verified BRAF mutated papillary craniopharyngioma

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Eva Marie Erfurth, MD, PhD

    lead OTHER

Principal Investigators

  • Peter Siesjö, MD. PhD. · Department of Neurosurgery, SUS, Lund Sweden

  • Sara Kinhult, MD. PhD · Department of Oncology, SUS, Lund Sweden

  • Eva Marie Erfurth, MD. PhD · Department of Endocrinology, SUS, Lund, Sweden

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-01
Primary Completion
2027-09-10
Completion
2028-04-10

Countries

  • Sweden

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05525273 on ClinicalTrials.gov