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Recruiting NCT06262919

Special Drug Use-results Surveillance of Tafinlar/Mekinist

— Observational BRAF V600E Mutation-positive Unresectable Advanced or Recurrent Solid Tumor

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Tafinlar/Mekinist.
Who it may be relevant to
Registry conditions: BRAF V600E Mutation-positive Unresectable Advanced or Recurrent Solid Tumor. Basic parameters: 6 years — 99 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Japan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Observational Study to Assess Safety and Effectiveness of Dabrafenib and Trametinib in Patients With BRAF V600E Mutation-positive Unresectable Advanced or Recurrent Solid Tumor

Overview

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.

Interventions

  • Drug Tafinlar/Mekinist
    There is no treatment allocation. Patients administered Tafinlar/Mekinist by prescription that have started before inclusion of the patient into the study will be enrolled.

Primary outcome measures

  • [Pediatric patients] Number of patients and incidence of adverse events/adverse reactions with respect to skeletal and sexual maturation [Time frame: Up to 8 years]
  • [Adult patients] overall response rate (ORR) [Time frame: 1 year]
Secondary outcome measures (3)
  • [Pediatric patients] Incidence proportion of ORR [Time frame: 1 year]
  • [Pediatric and adult patients] Incidence proportion of PFS [Time frame: 1 year]
  • [Pediatric patients] Number of patients with changes in height and body weight and sexual maturation [Time frame: Up to 8 years]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Japan · 70 centers
  • Novartis Investigative Site — Nagakute
  • Novartis Investigative Site — Nagoya
  • Novartis Investigative Site — Nagoya
  • Novartis Investigative Site — Nagoya
  • Novartis Investigative Site — Toyohashi
  • Novartis Investigative Site — Toyota
  • Novartis Investigative Site — Daisen
  • Novartis Investigative Site — Chiba
  • … and 62 more centers

Identifiers

NCT: NCT06262919 · CDRB436I1401

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗