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

This study is currently recruiting participants.

Verified July 2012 by Sanofi

Sponsor:

Information provided by (Responsible Party):

Sanofi

ClinicalTrials.gov Identifier:

NCT01497964

First received: December 6, 2011

Last updated: July 25, 2012

Last verified: July 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

December 6, 2011

Last Updated Date

July 25, 2012

Start Date ^ICMJE

January 2012

Estimated Primary Completion Date

June 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Objective Response Rate [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01497964 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Overall survival (OS) [ Time Frame: Up to a maximum of 2 years ] [ Designated as safety issue: No ]
Progression free survival (PFS) [ Time Frame: Up to a maximum of 2 years ] [ Designated as safety issue: No ]
Number of patients with adverse events [ Time Frame: Up to a maximum of 2 years ] [ Designated as safety issue: Yes ]
Pharmacokinetic parameter: Cmax [ Time Frame: 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.. ] [ Designated as safety issue: No ]
Pharmacokinetic parameter tmax [ Time Frame: 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.. ] [ Designated as safety issue: No ]
Pharmacokinetic parameter t1/2z [ Time Frame: 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.. ] [ Designated as safety issue: No ]
Pharmacokinetic parameter AUC [ Time Frame: 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 ] [ Designated as safety issue: No ]
Pharmacokinetic parameter AUClast [ Time Frame: 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 ] [ Designated as safety issue: No ]
Pharmacokinetic parameter CL [ Time Frame: 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 ] [ Designated as safety issue: No ]
Pharmacokinetic parameter Vss [ Time Frame: 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 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Phase 2, Multicenter Study of Cabazitaxel Single Agent Administered as a 1-Hour Intravenous Infusion Every 3 Weeks to Evaluate the Safety, Tolerability and Anti-tumor Activity of Cabazitaxel in Patients With Advanced Gastric Adenocarcinoma Who Have Failed Prior Chemotherapy Regimens

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 Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Gastric Cancer

Intervention ^ICMJE

Drug: cabazitaxel XRP6258

Pharmaceutical form: solution for infusion Route of administration: intravenous

Study Arm (s)

Experimental: Cabazitaxel

Cabazitaxel, several dosages

Intervention: Drug: cabazitaxel XRP6258

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

June 2013

Estimated Primary Completion Date

June 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion criteria:

Histologically or cytologically confirmed unresectable or metastatic gastric adenocarcinoma including adenocarcinoma of gastroesophageal junction, which have failed 2 prior chemotherapy regimens. (For countries where a standard of care has not been established for the 2nd line treatment for advanced gastric cancer, those who failed 1 or 2 prior chemotherapy regimens can be included)
Signed informed consent

Exclusion criteria:

Patients who have received >2 prior systemic chemotherapy regimens for advanced gastric cancer.
For patients entering part 2, those without at least one measurable lesion at baseline according to Response Evaluation Criteria in Solid Tumors 1.1 criteria
Eastern Cooperative Oncology Group performance status >1
Age <18 years
Inadequate organ and bone marrow function
Prior surgery, chemotherapy, targeted agents, investigational agents, or other anti-cancer therapy within 4 weeks prior to enrollment in the study
Prior radiation therapy within 6 weeks prior to enrollment (except palliative radiation for a local pain control)
Previous treatment with cabazitaxel
Known brain or leptomeningeal involvement of cancer
Patients with known acquired immunodeficiency syndrome (AIDS) related illness or known HIV infection requiring antiretroviral treatment.
Patients with active varicella zoster infection, or known hepatitis B or C infection.
History of severe hypersensitivity reaction ≥ grade 3 to drugs formulated with polysorbate 80 such as docetaxel

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: For site information, send an email with site number to

Contact-Us@sanofi-aventis.com

Location Countries ^ICMJE

Korea, Republic of

Administrative Information

NCT Number ^ICMJE

NCT01497964

Other Study ID Numbers ^ICMJE

ARD12417, U1111-1121-6247

Has Data Monitoring Committee

Responsible Party

Sanofi

Study Sponsor ^ICMJE

Sanofi

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Clinical Sciences & Operations

Sanofi

Information Provided By

Sanofi

Verification Date

July 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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