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Cabazitaxel in Asian Patients With Advanced Gastric Cancer Who Failed Prior Chemotherapy

NCT01497964 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2014-11-10

No results posted yet for this study

Summary

Primary Objective:

\- To evaluate the anti-tumor activity of cabazitaxel by assessing objective tumor response rate (ORR) at the recommended dose (RD) when administered as a single agent every 3 weeks in patients with advanced gastric adenocarcinoma who have failed prior chemotherapy regimens

Secondary Objectives:

* To determine the RD of cabazitaxel when administered as a single agent every 3 weeks
* To evaluate safety of cabazitaxel when administered as a single agent every 3 weeks
* To estimate the overall survival (OS) and progression free survival (PFS)
* To assess the pharmacokinetics (PK) profile of cabazitaxel in part 1

Conditions

Interventions

DRUG

cabazitaxel XRP6258

Pharmaceutical form: solution for infusion Route of administration: intravenous

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2013-05-31
Completion
2013-05-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT01497964 on ClinicalTrials.gov