Authorised Therapeutic exploratory (Phase II) papillary craniopharyngioma

Neoadjuvant and postoperative treatment with dabrafenib and trametinib for papillary craniopharyngioma

EU CTIS ID: 2024-517611-67-00

What this study is testing

To evaluate tumour response measured as reduction in tumour volume on MRI for patients with papillary craniopharyngioma on treatment with dabrafenib and trametinib.

  • Therapeutic exploratory (Phase II)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • 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

You likely can't join if

  • 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

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.