EGFR変異を有する固形悪性腫瘍を有する成人患者を対象とした、EGFR変異チロシンキナーゼ阻害剤EGF816の経口投与に関する第I/II相多施設共同非盲検試験
基本情報
- NCT ID
- NCT02108964
- ステータス
- 完了
- 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
- 225
- 治験依頼者名
- Novartis
概要
This is a Phase I/II, multi-center, open-label study, composed with a Phase I part (dose-escalation phase) followed by a Phase II part (expansion phase). The dose escalation phase was designed to determine as primary objective the maximum tolerated dose (MTD) or recommended Phase II dose (RP2D) of EGF816 monotherapy in adult subjects with locally advanced (stage IIIB) or metastatic (stage IV) NSCLC harboring specific EGFR mutations. Patients may have or not have received prior lines of antineoplastic therapy. An adaptive Bayesian Logistic Regression Model (BLRM) employing the escalation with overdose control (EWOC) principle will be used during the dose escalation part for dose level selection and MTD recommendation. The primary objective of the Phase II part is to estimate antitumor activity of EGF816 as measured by overall response rate (ORR) determined by Blinded Independent Review Committee (BIRC) assessment in accordance to RECIST 1.1.