Special Drug Use-results Surveillance of Tafinlar/Mekinist
- Conditions
- BRAF V600E Mutation-positive Unresectable Advanced or Recurrent Solid Tumor
- Interventions
- Drug: Tafinlar/Mekinist
- Registration Number
- NCT06262919
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
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.
- Detailed Description
In the Post-Marketing Surveillance (PMS), dabrafenib and trametinib are used as the marketed drugs. Registration of the corresponding patients is to be conducted by the central registered system under current medical practice.
Target number of adult patient is 65 (as the number of patients in the effectiveness analysis set).
Target number of pediatric patient is not determined. Estimated number of enrolled patients is approximately 20 (as the number of patients in the enrolled set)
The observation period for pediatric patients will last after the start of treatment until 8 years (planned, November 2031) after the approval of additional indications, regardless of discontinuation of the product, in order to collect long-term information from as many patients as possible during the reexamination period. The duration of observation for adult patients will be 1 year after the start of treatment with the product.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 110
- Patients who have given written consent to cooperate in this surveillance
- 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.
- Patients who start treatment with the product for BRAF-mutation-positive advanced/recurrent solid tumors (excluding colorectal cancer) after the approval of additional indications
- 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
- Patients with BRAF-mutation-positive malignant melanoma
- Patients with BRAF-mutation-positive non-small cell lung cancer
- Patients with BRAF-mutation-positive hairy cell leukemia
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Tafinlar/Mekinist Tafinlar/Mekinist Patients with BRAF V600E mutation positive unresectable advanced or recurrent solid tumors treated with dabrafenib and trametinib as per Japanese Package Insert.
- Primary Outcome Measures
Name Time Method [Pediatric patients] Number of patients and incidence of adverse events/adverse reactions with respect to skeletal and sexual maturation Up to 8 years 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.
[Adult patients] overall response rate (ORR) 1 year 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)
- Secondary Outcome Measures
Name Time Method [Pediatric patients] Incidence proportion of ORR 1 year 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)
[Pediatric patients] Number of patients with changes in height and body weight and sexual maturation Up to 8 years Number of pediatric patients with changes in height and body weight and sexual maturation is going to be collected
[Pediatric and adult patients] Incidence proportion of PFS 1 year Progression Free Survival (PFS) is the percentage of participants who did not have a progression event.
Trial Locations
- Locations (1)
Novartis Investigative Site
🇯🇵Yamagata, Japan