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

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.