Pharmacokinetics and Safety Study of Cabazitaxel in Cancer Patients With Renal Impairment

• Status: Completed
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Primary Objective:

• To assess potential impact of moderate and severe renal impairment on the pharmacokinetics of cabazitaxel

Secondary Objective:

• To assess the safety of cabazitaxel in patients with various degrees of renal impairment

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

Details

• Lead Sponsor: Sanofi

Criteria

Inclusion criteria :

• Diagnosis of histologically or cytologically proven non-hematologic malignancy. The cancer must be one that is either refractory to standard therapy or for which no standard therapy exists. Cabazitaxel is an adequate treatment option, as judged by investigator.

• Eastern Cooperative Oncology Group performance status 0 - 2

• Stable renal function

• Patients must have adequate liver and marrow function as defined below:

• Absolute neutrophil count ≥ 1.5x10^9/L

• Platelets ≥ 100x10^9/L

• Total bilirubin ≤ 1.0 x the institutions upper limit of normal

• AST (SGOT)/ALT (SGPT) ≤ 2.5 x the institutions upper limit of normal

• Alkaline phosphatase ≤ 2.5 x the institutions upper limit of normal

• Patient may have a Grade 1 or less neurotoxicity at study entry.

• Life expectancy > 3 months

• Age ≥ 18 years old

• If female, subject must use a double contraception method, except if she is sterilized for more than 3 months or postmenopausal.

• Having given written informed consent prior to any procedure related to the study

Exclusion criteria:

• Less than 4 weeks have elapsed from prior anticancer therapy (surgery, chemotherapy, radiation therapy, hormonal therapy and immunotherapy). Prior isotope therapy and radiotherapy to ≥ 30% of bone marrow are not allowed.

• Any of the following within 6 months prior to study enrollment: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, class III or IV congestive heart failure, stroke or transient ischemic attack.

• Any of the following within 3 months prior to study start: treatment resistant peptic ulcer disease, erosive esophagitis or gastritis, infectious or inflammatory bowel disease, diverticulitis, pulmonary embolism, or other uncontrolled thromboembolic event.

• Active hepatitis

• Acute renal failure (new or superimposed to pre-existing chronic renal impairment), nephrotic syndrome.

• Patients requiring dialysis during the study.

• History of hypersensitivity to docetaxel or polysorbate 80.

• Known acquired immunodeficiency syndrome (AIDS-related illnesses) or known HIV disease requiring antiretroviral treatment.

• Known brain metastases.

• If female, pregnancy or breast-feeding.

• Any treatment known to induce CYP isoenzymes (e.g., phenobarbital, phenytoin, carbamazepine, rifampicin, St John's Wort) or to strongly inhibit CYP3A4 activities (e.g., ketoconazole, itraconazole, macrolides, antiprotease agents, etc) is not allowed within 2 weeks before or during the test period of the pharmacokinetic sampling

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