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

• Status: Completed
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi

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.