小児におけるNTRK融合遺伝子を有する腫瘍の治療におけるラロトレクチニブの安全性と有効性を検証する研究

基本情報

NCT ID

NCT02637687

ステータス

実施中（募集終了）

試験のフェーズ

第1/第2相

試験タイプ

介入

目標被験者数

154

治験依頼者名

Bayer

概要

The study is being done to test the safety of a cancer drug called larotrectinib in children. The cancer must have a change in a particular gene (NTRK1, NTRK2 or NTRK3). Larotrectinib blocks the actions of these NTRK genes in cancer cells and can therefore be used to treat cancer. The first study part (Phase 1) is done to determine what dose level of larotrectinib is safe for children, how the drug is absorbed and changed by their bodies and how well the cancer responds to the drug. The main purpose of the second study part (Phase 2) is to investigate how well and how long different cancer types respond to the treatment with larotrectininb.

対象疾患

介入

依頼者（Sponsor）

実施施設 (3)