HMAによる治療歴のあるMDSまたはCMMLの成人患者におけるグアデシタビン（SGI-110）と治療選択の比較

基本情報

NCT ID

NCT02907359

ステータス

完了

試験のフェーズ

第3相

試験タイプ

介入

目標被験者数

417

治験依頼者名

Astex Pharmaceuticals, Inc.

概要

A Phase 3, randomized, open-label, parallel-group, multicenter study designed to evaluate the efficacy and safety of guadecitabine in participants with MDS or CMML who failed or relapsed after adequate prior treatment with azacitidine, decitabine, or both. This global study will be conducted in approximately 15 countries. Approximately 408 participants from approximately 100 study centers will be randomly assigned in a 2:1 ratio to either guadecitabine (approximately 272 participants) or Treatment Choice (approximately 136 participants). The study consists of a 21-day screening period, a treatment period, a safety follow-up visit, and a long-term follow-up period. The study is expected to last more than 2 years, and the duration of individual participant participation will vary. Participants may continue to receive treatment for as long as they continue to benefit.

対象疾患

介入

依頼者（Sponsor）

実施施設 (22)