Safety and Pharmacokinetic Study of Cabazitaxel in Patients With Advanced Solid Tumors and Liver Impairment
Status: Recruiting
Phase:
Diagnosis: Solid Tumor/Phase I
NCT ID: NCT01140607
(View complete trial on ClinicalTrials.gov)
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:
Susan Pandya, MD,
Beth Israel Deaconess Medical Center
Site-responsible Investigators:
Geoffrey Shapiro, MD, PhD,
Dana-Farber Cancer Institute
Contacts:
Beth-Israel Deaconess Medical Center:
Cancer Trials Call Center, 617-667-3060
Dana-Farber Cancer Institute:
Linda Pointon, 617-632-4391,
linda_pointon@dfci.harvard.edu
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.