Status:
COMPLETED
Safety and Pharmacokinetic Study of Cabazitaxel in Patients With Advanced Solid Tumors and Liver Impairment
Lead Sponsor:
Sanofi
Conditions:
Neoplasm Malignant
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
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 determ...
Detailed Description
The study consists of: * a screening phase (maximum length of 21-day). * a treatment phase with 21-day study treatment cycles. Cycle lengths may be extended up to maximum of 12 additional days in cas...
Eligibility Criteria
Inclusion
- 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
- Prior history of bone marrow transplant
- Any treatment known to induce CYP isoenzymes or to inhibit CYP3A4 activities within 2 weeks before or during the test period of the pharmacokinetic sampling. Moderate inhibitors within one week prior and during the pharmacokinetic sampling.
- Any contra-indications to midazolam, according to the applicable labeling.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Exclusion
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT01140607
Start Date
May 1 2010
End Date
July 1 2014
Last Update
July 21 2015
Active Locations (14)
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1
Investigational Site Number 840014
La Jolla, California, United States, 92093
2
Investigational Site Number 840013
Loma Linda, California, United States, 92354
3
Investigational Site Number 840020
Washington D.C., District of Columbia, United States, 20037
4
Investigational Site Number 840016
Jacksonville, Florida, United States, 32207