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

NCT02448329 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2022-06-15

No results posted yet for this study

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 .

Conditions

  • Advanced Gastric Adenocarcinoma

Interventions

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

Sponsors & Collaborators

  • Samsung Medical Center

    lead OTHER

Principal Investigators

  • Jee yun Lee, MD,Ph.D. · Samsung Medical Center,Seoul,Korea

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-14
Primary Completion
2019-12-31
Completion
2021-04-19

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02448329 on ClinicalTrials.gov