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

Phase 1

• Conditions: Papillary craniopharyngioma; MedDRA version: 23.1Level: LLTClassification code 10084813Term: Papillary craniopharyngiomaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2021-000087-30-SE
• Lead Sponsor: Skane University Hospital, Dept of Endocrinology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-14
• Last Update Posted: 3 June 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 25

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified