Safety and Pharmacokinetic Study of Cabazitaxel in Patients With Advanced Solid Tumors and Liver Impairment
- 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
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I Safety and Pharmacokinetic Study of XRP6258 (Cabazitaxel) In Advanced Solid Tumor Patients With Varying Degrees of Hepatic Impairment|
- Incidence of Dose Limiting Toxicities (DLT) [ Time Frame: cycle 1 (3 weeks) ] [ Designated as safety issue: Yes ]A clinical adverse event or a laboratory abnormality is defined as DLT when it is drug-related as assessed by the investigator and agreed upon by the study committee.
- Safety investigations (physical examination, vital signs and laboratory tests) [ Time Frame: up to 30 days after the last dosing ] [ Designated as safety issue: Yes ]
Physical examination includes Eastern Cooperative Oncology Group (ECOG) performance status and signs and symptoms.
Vital signs includes weight, temperature, blood pressure and heart rate.
Laboratory tests includes hematology, coagulation, biochemistry and urinalysis. Laboratory abnormalities are graded according to the NCI CTCAE v.4.0
- Pharmacokinetic profile of Cabazitaxel (AUC, Cmax, t1/2, CL, and Vss) from plasma concentration [ Time Frame: cycle 1 (3 weeks) ] [ Designated as safety issue: No ]
|Study Start Date:||May 2010|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
IV infusion is given over 1 hour on Day1 of each cycle (every 3 weeks).
Drug: Cabazitaxel (XRP6258)
Pharmaceutical form:solution for infusion
Route of administration: intravenous
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 case of unresolved toxicity.
Patients continue to receive treatment until they experience, unacceptable toxicities/AEs, disease progression ,withdraw their consent, or the investigator decides to discontinue the patient, or study cut-off, whichever comes first.
- a 30-day follow-up visit after the last dose of study medication.
The cut off date is when the last patient treated has completed cycle 1 and the subsequent 30 days follow-up.
Patients may continue to be treated as long as they are benefiting from study treatment and have not met study withdrawal criteria.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01140607
|United States, California|
|Investigational Site Number 840014|
|La Jolla, California, United States, 92093|
|Investigational Site Number 840013|
|Loma Linda, California, United States, 92354|
|United States, District of Columbia|
|Investigational Site Number 840020|
|Washington, District of Columbia, United States, 20037|
|United States, Florida|
|Investigational Site Number 840016|
|Jacksonville, Florida, United States, 32207|
|Investigational Site Number 840002|
|Tampa, Florida, United States, 33612|
|United States, Illinois|
|Investigational Site Number 840017|
|Decatur, Illinois, United States, 62526|
|United States, Louisiana|
|Investigational Site Number 840003|
|Metairie, Louisiana, United States, 70006|
|United States, Maryland|
|Investigational Site Number 840019|
|Baltimore, Maryland, United States, 21201|
|United States, Massachusetts|
|Investigational Site Number 840012|
|Boston, Massachusetts, United States, 02115|
|United States, Missouri|
|Investigational Site Number 840001|
|St Louis, Missouri, United States, 63110|
|United States, Ohio|
|Investigational Site Number 840021|
|Canton, Ohio, United States, 44718|
|Investigational Site Number 840007|
|Cincinnati, Ohio, United States, 45267-0542|
|United States, Pennsylvania|
|Investigational Site Number 840010|
|Bethlehem, Pennsylvania, United States, 18015|
|United States, Texas|
|Investigational Site Number 840006|
|San Antonio, Texas, United States, 78229|
|Study Director:||Clinical Sciences & Operations||Sanofi|