再発性および/または難治性固形腫瘍および非ホジキンリンパ腫患者を対象としたCC-90011の安全性および有効性試験
基本情報
- NCT ID
- NCT02875223
- ステータス
- 中止
- 試験のフェーズ
- 第1相
- 試験タイプ
- 介入
- 目標被験者数
- 75
- 治験依頼者名
- Celgene
概要
Study CC-90011-ST-001 is an open-label, Phase 1, dose escalation and expansion, First-In-Human (FIH) clinical study of CC-90011 in subjects with advanced unresectable solid tumors (enriched for grade 2 NENs, grade 2 NETs and NECs) and R/R NHL (MZL, including extranodal MZL \[EMZL\], splenic MZL \[SMZL\], nodal MZL \[NMZL\], and histologic transformation of MZL). The dose escalation part (Part A) of the study will explore escalating oral doses of CC-90011 to estimate the maximum tolerated dose (MTD) of CC-90011. The expansion part (Part B) will further evaluate the safety and efficacy of CC-90011 administered at or below the MTD in 3 selected expansion cohorts of approximately 10-20 evaluable subjects each, in order to further define the RP2D.