既治療の局所進行性または転移性胆管癌患者におけるイボシデニブの早期アクセス試験

基本情報

NCT ID

NCT05876754

ステータス

募集中

試験のフェーズ

第3相

試験タイプ

介入

目標被験者数

220

治験依頼者名

Servier

概要

A Phase 3b research study to consolidate the data that ivosidenib is safe and effective in adult patients with previously treated, locally advanced, or metastatic cholangiocarcinoma (CCA). All patients who meet inclusion criteria will be enrolled to receive ivosidenib tablets orally once daily for 28 day cycles, continuing as long as clinical benefit and consent for participation is maintained. There will be a minimum of 6 study visits from screening until the final follow-up, if one cycle of treatment is completed and consent is maintained through 18 months of follow-up. Each additional cycle completed will add one study visit, on the first day of each cycle.

対象疾患

介入

依頼者（Sponsor）

実施施設 (6)