Phase II study of TP300 in patients with advanced gastric or gastro-oesophageal junction adenocarcinoma.

ABSTRACT:

Background

TP300, a recently developed synthetic camptothecin analogue, is a highly selective topoisomerase I inhibitor. A phase I study showed good safety and tolerability. As camptothecins have proven active in oesophago-gastric adenocarcinomas, in this phase II study we assessed the efficacy and safety of TP300 in patients with gastric or gastro-oesophageal junction (GOJ) adenocarcinomas.

Methods

Eligible patients had metastatic or locally advanced gastric or Siewert Types II or III GOJ inoperable adenocarcinoma. Patients were chemotherapy naïve unless this had been administered in the perioperative setting. TP300 was administered as a 1-h intravenous infusion every 3 weeks (a cycle) for up to 6 cycles at a starting dose of 8 mg/m² with intra-patient escalation

SUBMITTER: Propper D 

PROVIDER: S-EPMC5057500 | biostudies-literature | 2016 Oct

REPOSITORIES: biostudies-literature