Special Drug Use-results Surveillance of Tafinlar/Mekinist

Novartis

Status: Enrolling

Conditions: BRAF V600E Mutation-positive Unresectable Advanced or Recurrent Solid Tumor

Treatments: Drug: Tafinlar/Mekinist

Study type: Observational

Funder types: Industry

Identifiers

NCT06262919

CDRB436I1401

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 estimated patients

Sex: All

Ages: 6 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

110 participants in 1 patient group

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.

Treatment:

Drug: Tafinlar/Mekinist