Special Drug Use-results Surveillance of Tafinlar/Mekinist

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат 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.

Первичные конечные точки

• [Pediatric patients] Number of patients and incidence of adverse events/adverse reactions with respect to skeletal and sexual maturation [Срок оценки: Up to 8 years]
• [Adult patients] overall response rate (ORR) [Срок оценки: 1 year]

Вторичные конечные точки (3)

• [Pediatric patients] Incidence proportion of ORR [Срок оценки: 1 year]
• [Pediatric and adult patients] Incidence proportion of PFS [Срок оценки: 1 year]
• [Pediatric patients] Number of patients with changes in height and body weight and sexual maturation [Срок оценки: Up to 8 years]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Япония · 70 центров

• 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
• … и ещё 62 центра

Идентификаторы

NCT: NCT06262919 · CDRB436I1401

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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