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

Gastric Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01497964
• Other study ID #: ARD12417
• Secondary ID: U1111-1121-6247
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: December 6, 2011
• Last updated: November 7, 2014
• Start date: December 2011
• Est. completion date: May 2013

Study information

• Verified date: November 2014
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• cabazitaxel XRP6258
Pharmaceutical form: solution for infusion Route of administration: intravenous

Locations

Country	Name	City	State
Korea, Republic of	Investigational Site Number 410001	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate		Up to 2 years	No
Secondary	Overall survival (OS)		Up to a maximum of 2 years	No
Secondary	Progression free survival (PFS)		Up to a maximum of 2 years	No
Secondary	Number of patients with adverse events		Up to a maximum of 2 years	Yes
Secondary	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..	No
Secondary	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..	No
Secondary	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..	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No