Phase I/II study of sorafenib in combination with erlotinib for recurrent glioblastoma as part of a 3-arm sequential accrual clinical trial: NABTC 05-02.

Huanwen Chen,John Kuhn,Kathleen R Lamborn,Lauren E Abrey,Lisa M DeAngelis,Frank Lieberman,H Ian Robins,Susan M Chang,W K Alfred Yung,Jan Drappatz,Minesh P Mehta,Victor A Levin,Kenneth Aldape,Janet E Dancey,John J Wright,Michael D Prados,Timothy F Cloughesy,Patrick Y Wen,Mark R Gilbert

Neuro-oncology advances（2020）

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摘要

This study identified the MTD and DLTs for sorafenib and erlotinib combination therapy for recurrent GBMs; however, efficacy data did not meet the primary endpoint. This study also demonstrates the feasibility of a novel sequential accrual clinical trial design that optimizes patient recruitment for multiarm studies, which is particularly effective for multicenter clinical trials.

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关键词

erlotinib,glioblastoma,molecular therapy,novel trial design,sorafenib

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