At a glance
ClinicalIndex Comparison Record- ✓Age ≥12 months and <18 years at enrollment
- ✓BRAF V600 mutation-positive tumor confirmed in CLIA-approved or equivalent laboratory
- ✓Recurrent, refractory, or progressive disease after ≥1 standard therapy (exception: metastatic unresectable melanoma eligible for first-line)
- ✓At least one evaluable lesion
- ✕Previous RAF inhibitor, MEK inhibitor, or dabrafenib treatment (Part 2 only); sorafenib exception allowed
- ✕Other active malignancy (exception: disease-free >3 years, completely resected non-melanoma skin cancer, in situ carcinoma, or CLL in stable remission)
- ✕Chemotherapy or radiotherapy within 3 weeks (6 weeks for nitrosoureas/mitomycin C) prior to first dose
- ✕Unresolved Grade 2 or higher toxicity from prior anti-cancer therapy (except clinically irrelevant effects like alopecia or neuropathy)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase I/IIa, 2-Part, Multi-Center, Single-Arm, Open-Label Study to Determine the Safety, Tolerability and Pharmacokinetics of Oral Dabrafenib in Children and Adolescent Subjects With Advanced BRAF V600-Mutation Positive Solid Tumors
In Brief
A Phase 2 clinical trial evaluating Dabrafenib for Neoplasms, Brain. Completed, enrolled 85 participants across 26 sites in 10 countries.
Detailed Summary
This was a 2-part, Phase I/IIa, multi-center, open label, study in pediatric and adolescent patients with advanced BRAF V600 mutation-positive solid tumors. Part 1 was a dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). Part 2 was an expansion study to further evaluate the safety, tolerability, and clinical activity of dabrafenib in 4 tumor-specific pediatric populations. Patients participated in only either part 1 or part 2 of the study.
Study Details
Timeline
Interventions
Dabrafenib is available as 50 mg or 75 mg capsules and as oral suspension (10 mg/mL for subjects unable to swallow capsules). Dabrafenib (either formulation) will be administered orally as a single dose on Day 1 and twice daily from Day 2, based on weight at the appropriate study dose level.