Safety and Pharmacokinetic Study of Cabazitaxel in Patients With Advanced Solid Tumors and Liver Impairment

Status: Recruiting
Diagnosis: Solid Tumor/Phase I
NCT ID: NCT01140607 (View complete trial on
DFCI Protocol ID: 10-162


Primary Objectives: - To determine the maximum tolerated dose (MTD) and safety of Cabazitaxel when administered to advanced solid tumor patients with varying degrees of hepatic impairment - To determine the pharmacokinetics (PKs) of Cabazitaxel in patients with varying degrees of hepatic impairment - To correlate PK variables with pharmacodynamic (PD) safety parameters in order to guide prescribers with regard to dosing in this patient population


Conducting Institutions:
Beth-Israel Deaconess Medical Center, Dana-Farber Cancer Institute

Overall PI:
Daniel Cho, MD, Beth Israel Deaconess Medical Center

Site-responsible Investigators:
Geoffrey Shapiro, MD, PhD, Dana-Farber Cancer Institute

Beth-Israel Deaconess Medical Center: Cancer Trials Call Center, 617-667-3060
Dana-Farber Cancer Institute: Andrew Wolanski, 617-632-6623,

Eligibility Criteria

Inclusion criteria: - Patients with a diagnosis of advanced, measurable or non-measurable, non-hematological cancer who have varying degrees of hepatic impairment. The cancer must be one that is either refractory to standard therapy or for which no standard therapy exists. Exclusion criteria: - Eastern Cooperative Oncology Group (ECOG) performance status (PS) >2 - Life expectancy <3 months - Need for a major surgical procedure or radiation therapy during the study - Evidence of another active malignancy - Prior chemotherapy, other investigational drug, biological therapy, targeted non-cytotoxic therapy and radiotherapy within 3 weeks prior to registration - Patients with known history of Gilbert's syndrome - Prior treatment with Cabazitaxel and a history of severe (Grade ≥3) hypersensitivity to taxanes, polysorbate-80, or to compounds with similar chemical structures The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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