Dose-Escalation, Safety, Pharmacokinetics Study of Cabazitaxel With Gemcitabine In Patients With Solid Tumor

Inclusion criteria:

• Histologically or cytologically confirmed advanced solid malignancy that is metastatic or unresectable, and for which standard curative measures do not exist.

Exclusion criteria:

• ECOG performance status (PS) > or =2
• Anticipation of need for a major surgical procedure or radiation therapy during the study treatment
• Absence of completion of all prior chemotherapy, biological therapy, targeted non-cytotoxic therapy > or = 3 weeks; and radiotherapy > or = 4 weeks prior to registration. For part 2 only, prior treatment with radiotherapy, chemoembolization therapy, or cryotherapy is allowed if these therapies are not directed to the areas of measurable disease being used for the purposes of this protocol. (4 weeks of washout period is required prior to start the treatment in Part 2)
• Concurrent treatment in another clinical trial or with any other cancer therapy or patients planning to receive these treatments during the study
• Other concurrent serious illness or medical condition, including active infection or HIV disease
• History of any other malignancy with the exception of adequately treated basal cell or squamous cell skin cancer, or in situ carcinoma of the cervix uteri
• Patients without resolution of all clinically significant toxic effects (excluding alopecia) of any prior therapy to grade < or = 1 by NCI-CTCAE, version 3.0 or to within the limits listed in the specific inclusion/exclusion criteria
• Other severe acute or chronic medical or psychiatric condition, or significant laboratory abnormality requiring further investigation that may cause undue risk for the patient's safety, inhibit protocol participation, or interfere with interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study
• Symptomatic brain metastases or leptomeningeal disease. Patients with asymptomatic or stable brain metastases are allowed
• Women of childbearing potential not protected by highly effective contraceptive method of birth control. All patients of childbearing potential that do not have a negative pregnancy test within the 7 days prior to registration
• Patients who are pregnant or breastfeeding
• For part 2, absence of measurable disease as defined by the most current version of the RECIST 1.1. For the Part 1 component, patients with non-measurable disease are accepted
• Inadequate bone marrow or liver or renal organ function
• Any condition which is considered a contraindication to gemcitabine in the local labelling
• Prior treatment with cabazitaxel within the last 2 years
• History of severe hypersensitivity grade 3 or 4 to taxanes, Polysorbate-80, or to compounds with similar chemical structures
• Any treatment known to potentially interact with midazolam

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.