Phase II Trial of Alisertib in Combination with Irinotecan and Temozolomide for Patients with Relapsed or Refractory Neuroblastoma.

ABSTRACT:

Purpose

In phase I testing, alisertib tablets with irinotecan and temozolomide showed significant antitumor activity in patients with neuroblastoma. This study sought to confirm activity of this regimen; evaluate an alisertib oral solution; and evaluate biomarkers of clinical outcomes.

Patients and methods

We conducted a two-stage phase II trial of alisertib tablets (60 mg/m²/dose × 7 days), irinotecan (50 mg/m²/dose i.v. × 5 days), and temozolomide (100 mg/m²/dose orally × 5 days) in patients with relapsed or refractory neuroblastoma. The primary endpoint was best objective response. A separate cohort was treated with alisertib at 45 mg/m² using oral solution instead of tablets. Exploratory analyses sought to identify predictors o

SUBMITTER: DuBois SG 

PROVIDER: S-EPMC6295246 | biostudies-literature | 2018 Dec

REPOSITORIES: biostudies-literature