Post-marketing Surveillance Protocol Number; CDRB436I1401
- Conditions
- BRAF V600E mutation-positive unresectable advanced or recurrent solid tumor
- Registration Number
- JPRN-jRCT2031230623
- Lead Sponsor
- sato masayuki
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 90
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
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pediatric patients:Number of patients and incidence of adverse events / adverse drug reactions of impairment in growth and development <br>Adult patients:ORR
- Secondary Outcome Measures
Name Time Method