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Study of AZD5363 in Combination With Paclitaxel, in Advanced Gastric Adenocarcinoma Patients Harboring PIK3CA Mutation and/or PIK3CA Amplification as a Second-line Chemotherapy

NCT02451956 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2019-12-30

No results posted yet for this study

Summary

This study is a single arm, single center phase II study of AZD5363 in combination with paclitaxel in patients with advanced gastric adenocarcinoma harboring PIK3CA mutation or amplification as a second line chemotherapy.

Patients will receive AZD 5363 plus weekly paclitaxel combination regimen. A arm is composed of 25 patients.

Tumour evaluation using RECIST 1.1 will be conducted at screening (within 28 days prior to first dose) and every 8 weeks relative to the date of enrollment, up to week 40, then every 16 weeks until objective disease progression (within a window of +/- 7 days of the scheduled date).

Study treatment will be continued until objective disease progression.

Conditions

  • Advanced Gastric Cancer

Interventions

DRUG

AZD5363

Dosage and Schedule : AZD5363 400mg bid 4 days on/ 3 days off of a 7 day cycle for each week

DRUG

paclitaxel

paclitaxel 80mg/m2 given days 1, 8 and 15 of a 28 day cycle.

Sponsors & Collaborators

  • Samsung Medical Center

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-07
Primary Completion
2019-05-24
Completion
2019-05-24

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 NCT02451956 on ClinicalTrials.gov