Treatment with the drugs dabrafenib and trametinib before or after operation for the tumour papillary craniopharyngioma

Neoadjuvant and postoperative treatment with dabrafenib and trametinib for papillary craniopharyngioma

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-000087-30-SE

Enrollment

Registered

2021-04-14

Start date

2021-07-06

Completion date

Unknown

Last updated

2025-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Papillary craniopharyngioma MedDRA version: 23.1 Level: LLT Classification code 10084813 Term: Papillary craniopharyngioma System Organ Class: 100000004864

Interventions

Trade Name: Tafinlar Pharmaceutical Form: Capsule, hard Trade Name: Mekinist Pharmaceutical Form: Film-coated tablet

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Histologically verified papillary craniopharyngioma 2. BRAFmut V600E, verified immunohistochemically and with sequencing. 3. Newly diagnosed tumour or recurrence after previous surgery, where additional surgery would give serious or permanent sequelae. 4. Age over 18 years. 5. Performance status acccording to ECOG 0-2 6. Adequate organ function Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 22 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 3

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate tumour response measured as reduction in tumour volume on MRI for patients with papillary craniopharyngioma on treatment with dabrafenib and trametinib.;Secondary Objective: 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;Primary end point(s): To evaluate tumour response measured as reduction in tumour volume on MRI for patients with papillary craniopharyngioma on treatment with dabrafenib and trametinib.;Timepoint(s) of evaluation of this end point: 5 years after initiation of study	—

Measure

Time frame

Main Objective: To evaluate tumour response measured as reduction in tumour volume on MRI for patients with papillary craniopharyngioma on treatment with dabrafenib and trametinib.;Secondary Objective: 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;Primary end point(s): To evaluate tumour response measured as reduction in tumour volume on MRI for patients with papillary craniopharyngioma on treatment with dabrafenib and trametinib.;Timepoint(s) of evaluation of this end point: 5 years after initiation of study

—

Secondary

Measure	Time frame
Secondary end point(s): 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;Timepoint(s) of evaluation of this end point: 5 years after study initiation	—

Measure

Time frame

Secondary end point(s): 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;Timepoint(s) of evaluation of this end point: 5 years after study initiation

—

Countries

Sweden

Contacts

Public ContactEndokrinmottagningen

Skane University Hospital, Dept of Endocrinology

eva-marie.erfurth@med.lu.se+46461710007123

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026