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

Phase 1

Completed

• Conditions: Gastric Cancer
• Interventions: Drug: cabazitaxel XRP6258

• Registration Number: NCT01497964
• Lead Sponsor: Sanofi

Brief 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

Detailed Description

Patients will be treated until disease progression, unacceptable toxicity, or patient's refusal of further study treatment. All patients will be followed during and after the study treatment until death or the end of study, whichever comes first.

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2011-12-06
• Study First Submitted QC: 2011-12-22
• Study First Posted: 2011-12-23
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-07
• Last Update Posted: 2014-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cabazitaxel	cabazitaxel XRP6258	Cabazitaxel, several dosages

Primary Outcome Measures

Name	Time	Method
Objective Response Rate	Up to 2 years

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic parameter AUClast	pre-infusion, end of infusion, 5, 15, 30 min, 1, 3, 5, 8 hours after end of infusion, 24, 48, 72, 120, 168, 216 hours after start of infusion
Pharmacokinetic parameter Vss	pre-infusion, end of infusion, 5, 15, 30 min, 1, 3, 5, 8 hours after end of infusion, 24, 48, 72, 120, 168, 216 hours after start of infusion
Overall survival (OS)	Up to a maximum of 2 years
Pharmacokinetic parameter: Cmax	pre-infusion, end of infusion, 5, 15, 30 min, 1, 3, 5, 8 hours after end of infusion, 24, 48, 72, 120, 168, 216 hours after start of infusion..
Pharmacokinetic parameter tmax	pre-infusion, end of infusion, 5, 15, 30 min, 1, 3, 5, 8 hours after end of infusion, 24, 48, 72, 120, 168, 216 hours after start of infusion..
Progression free survival (PFS)	Up to a maximum of 2 years
Number of patients with adverse events	Up to a maximum of 2 years
Pharmacokinetic parameter AUC	pre-infusion, end of infusion, 5, 15, 30 min, 1, 3, 5, 8 hours after end of infusion, 24, 48, 72, 120, 168, 216 hours after start of infusion
Pharmacokinetic parameter CL	pre-infusion, end of infusion, 5, 15, 30 min, 1, 3, 5, 8 hours after end of infusion, 24, 48, 72, 120, 168, 216 hours after start of infusion
Pharmacokinetic parameter t1/2z	pre-infusion, end of infusion, 5, 15, 30 min, 1, 3, 5, 8 hours after end of infusion, 24, 48, 72, 120, 168, 216 hours after start of infusion..

Trial Locations

Locations (1)

Investigational Site Number 410001; 🇰🇷 Seoul, Korea, Republic of