TRAMETINIB for Papillary craniopharyngioma

Inclusion criteria

• {"criterion_text":"- 1. Histologically verified papillary craniopharyngioma\n- 2. BRAFmut V600E, verified immunohistochemically and with sequencing.\n- 3. Newly diagnosed tumour or recurrence after previous surgery, where additional surgery would give serious or permanent sequelae.\n- 4. Age over 18 years.\n- 5. Performance status acccording to ECOG 0-2\n- 6. Adequate organ function"}

Exclusion criteria

• {"criterion_text":"- 1. Ongoing treatment with prohibited drugs (strong inducers of CYP2C8 or CYP3A4).\n- 2. Known cardiovascular disease where MEK-inhibitor is contraindicated, e g serious heart failure, increased QTc time, uncontrolled arrythmia, recent myocardial infarction, uncontrolled hypertension\n- 3. Active bleeding\n- 4. Thromboembolic event last 6 months\n- 5- Known serious ocular disease\n- 6. Surgery last 3 weeks\n- 7. Cohort b: radiotherapy last 3 months"}

Primary endpoints

• {"endpoint_text":"- To evaluate tumour response measured as reduction in tumour volume on MRI for patients with papillary craniopharyngioma on treatment with dabrafenib and trametinib.","definition_or_measurement_approach":"Tumour response measured as reduction in tumour volume on MRI (reduction in tumour volume on MRI)."}

Secondary endpoints

• {"endpoint_text":"- To evaluate treatment with dabrafenib and trametinib for the following aspects: - response according to RECIST - response duration for patients who are treated without subsequent surgery - number of patients that become operable after neoadjuvant treatment - progression free survival after 1 and 2 years - quality of life during and after treatment - the effect of treatment on vision, cognition and hypothalamic function","definition_or_measurement_approach":"As stated: response according to RECIST; response duration for patients treated without subsequent surgery; number of patients rendered operable after neoadjuvant treatment; progression-free survival at 1 and 2 years; quality of life assessments during and after treatment; assessment of vision, cognition and hypothalamic function."}

Sweden

Earliest CTIS Part Ii Submission Date

24-09-2024

Latest Decision Or Authorization Date

18-10-2024

Processing Time Days

24

Number Of Sites

2

Number Of Participants

25

Primary sponsor

Full Name

Region Skane

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Sweden

Third parties

• {"country":"","full_name":"Novartis","duties_or_roles":"Monetary support","organisation_type":""}