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
Inclusion 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.