drugset / Trial / NCT02448329

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

NCT02448329

Phase 2 Completed 26 enrolled Samsung Medical Center
NaSingle-groupOpen-labelTreatment

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 .

Timeline

Start
2015-01-14
Primary completion
2019-12
Completion
2021-04-19

Drugs

EvaluationDrugModalityDoseRoute
Subject Adavosertib Small molecule 225 mg
Background Paclitaxel Small molecule 80 mg/m2 Intravenous