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

Primary Purpose

Gastric Cancer

Status

Completed

Phase

Phase 1

Locations

Korea, Republic of

Study Type

Interventional

Intervention

cabazitaxel XRP6258

About this trial

This is an interventional treatment trial for Gastric Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Investigational Site Number 410001

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cabazitaxel

Arm Description

Cabazitaxel, several dosages

Outcomes

Primary Outcome Measures

Objective Response Rate

Secondary Outcome Measures

Overall survival (OS)

Progression free survival (PFS)

Number of patients with adverse events

Pharmacokinetic parameter: Cmax

Pharmacokinetic parameter tmax

Pharmacokinetic parameter t1/2z

Pharmacokinetic parameter AUC

Pharmacokinetic parameter AUClast

Pharmacokinetic parameter CL

Pharmacokinetic parameter Vss

Full Information

NCT ID

NCT01497964

First Posted

December 6, 2011

Last Updated

November 7, 2014

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT01497964

Brief Title

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

Acronym

GASTANA

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2014

Overall Recruitment Status

Completed

Study Start Date

December 2011 (undefined)

Primary Completion Date

May 2013 (Actual)

Study Completion Date

May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastric Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cabazitaxel

Arm Type

Experimental

Arm Description

Cabazitaxel, several dosages

Intervention Type

Drug

Intervention Name(s)

cabazitaxel XRP6258

Intervention Description

Pharmaceutical form: solution for infusion Route of administration: intravenous

Primary Outcome Measure Information:

Title

Objective Response Rate

Time Frame

Up to 2 years

Secondary Outcome Measure Information:

Title

Overall survival (OS)

Time Frame

Up to a maximum of 2 years

Title

Progression free survival (PFS)

Time Frame

Up to a maximum of 2 years

Title

Number of patients with adverse events

Time Frame

Up to a maximum of 2 years

Title

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..

Title

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..

Title

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..

Title

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

Title

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

Title

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

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Sciences & Operations

Organizational Affiliation

Sanofi

Official's Role

Study Director

Facility Information:

Facility Name

Investigational Site Number 410001

City

Seoul

ZIP/Postal Code

138-736

Country

Korea, Republic of

12. IPD Sharing Statement

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

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