Post-marketing Surveillance Protocol Number; CDRB436I1401

Special drug use-results surveillance of Tafinlar/Mekinist (BRAF-mutation-positive advanced/recurrent solid tumors(excluding colorectal cancer), CDRB436I1401)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT2031230623

Enrollment

Registered

2024-02-08

Start date

2024-01-31

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

BRAF V600E mutation-positive unresectable advanced or recurrent solid tumor

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Pediatric patients:Number of patients and incidence of adverse events / adverse drug reactions of impairment in growth and development Adult patients:ORR	—

Contacts

Public ContactNovartis Direct

Novartis Pharma. K.K.

sm.pms@novartis.com+81-120-003-293

Outcome results