Study of AZD1775 in Combination With Paclitaxel, in Advanced Gastric Adenocarcinoma Patients Harboring TP53 Mutation as a Second-line Chemotherapy

Advanced Gastric Adenocarcinoma Clinical Trial

Status Completed

Clinical Trial Summary

This study is a single arm, single center phase II study of AZD1775 in combination with paclitaxel in patients with advanced gastric adenocarcinoma harboring TP53 mutation as a second-line chemotherapy.

Patients will receive AZD 1775 plus weekly paclitaxel combination regimen. The arm is composed of 25 patients.

AZD1775 225 mg BID q 12 hours (x 5 doses) administered days 1~3 + paclitaxel 80 mg/m2 given days 1, 8 and 15 of a 28 day cycle.

Tumour evaluation using Response Evaluation Criteria in Solid Tumors 1.1 will be conducted at screening every 16 weeks until objective disease progression .

Clinical Trial Description

AZD1775 is an inhibitor of Wee1, a protein tyrosine kinase. Wee1 phosphorylates and inhibits cyclin-dependent kinases 1 (CDK1) and 2 (CDK2), and is involved in regulation of the intra-S and G2 cell cycle checkpoints.

In in vitro and in vivo preclinical models, AZD1775 selectively enhanced chemotherapy induced death of cells deficient in p53 signaling. Tumor context-specific sensitization to the DNA damaging agents gemcitabine and platinums was observed in TOV21G (ovarian carcinoma) cell lines matched for wild type and knock down of p53. ;

Related Conditions & MeSH terms

• Adenocarcinoma
• Advanced Gastric Adenocarcinoma

• NCT number: NCT02448329
• Study type: Interventional
• Source: Samsung Medical Center
• Status: Completed
• Phase: Phase 2
• Start date: January 14, 2015
• Completion date: April 19, 2021