Clinical trial · Observational
Special Drug Use-results Surveillance of Tafinlar/Mekinist
Observational Study to Assess Safety and Effectiveness of Dabrafenib and Trametinib in Patients With BRAF V600E Mutation-positive Unresectable Advanced or Recurrent Solid Tumor
NCT06262919CI-TRIAL-00115021recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a prospective, multicenter, single-arm, non-interventional and observational J-PMS conducted by the central registration system and operated in Electronic data capture.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| BRAF V600E Mutation-positive Unresectable Advanced or Recurrent Solid Tumor | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tafinlar/Mekinist | Drug | Dabrafenib/Trametinib Regimen | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Tafinlar/Mekinist
- description
- Patients with BRAF V600E mutation positive unresectable advanced or recurrent solid tumors treated with dabrafenib and trametinib as per Japanese Package Insert.
- interventionNames
- Drug: Tafinlar/Mekinist
Primary outcomes (2)
- measure
- [Pediatric patients] Number of patients and incidence of adverse events/adverse reactions with respect to skeletal and sexual maturation
- timeFrame
- Up to 8 years
- description
- To evaluate impairment in growth and development in pediatric patients (skeletal and sexual maturation) of dabrafenib and/or trametinib in pediatric patients under 18 years old in the post marketing phase.
- measure
- [Adult patients] overall response rate (ORR)
- timeFrame
- 1 year
- description
- The Overall Response Rate (ORR) is defined as the proportion of patients with a best OR of confirmed Complete Response (CR) or Partial Response (PR)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 6 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients who have given written consent to cooperate in this surveillance 2. For patients aged \< 18 years at the start of treatment with the product, their legally authorized representative must have given written informed consent for cooperation in this surveillance prior to patient enrollment. 3. Patients who start treatment with the product for BRAF-mutation-positive advanced/recurrent solid tumors (excluding colorectal cancer) after the approval of additional indications Exclusion Criteria: 1. Patients who have received or are receiving a product containing the same ingredient as the product in any other study or research than this surveillance 2. Patients with BRAF-mutation-positive malignant melanoma 3. Patients with BRAF-mutation-positive non-small cell lung cancer 4. Patients with BRAF-mutation-positive hairy cell leukemia
References
Publications (0)
Data not yet available
No reference posted for this study.