NCT02448329

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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 .

Detailed 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.

Conditions

• Advanced Gastric Adenocarcinoma

Interventions

Type	Name	Description
DRUG	AZD1775	AZD1775 225 mg BID q 12 hours (x5 doses, 2.5 days) administered days 1\~3
DRUG	paclitaxel	paclitaxel 80 mg/m2 given days 1, 8 and 15 of a 28 day cycle

Timeline

• Start date: 2015-01-14
• Primary completion: 2019-12-01
• Completion: 2021-04-19
• First posted: 2015-05-19
• Last updated: 2022-06-15

Locations

1 site across 1 country: South Korea