Safety and Pharmacokinetic Study of Cabazitaxel in Patients With Advanced Solid Tumors and Liver Impairment
Information source: Sanofi
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Neoplasm Malignant
Intervention: Cabazitaxel (XRP6258) (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: Sanofi Official(s) and/or principal investigator(s):
Clinical Sciences & Operations, Study Director, Affiliation: Sanofi
Overall contact:
For site information, send an email with site number to, Email: Contact-Us@sanofi.com
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 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
Clinical Details
Official title: Phase I Safety and Pharmacokinetic Study of XRP6258 (Cabazitaxel) In Advanced Solid Tumor Patients With Varying Degrees of Hepatic Impairment
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Incidence of Dose Limiting Toxicities (DLT)
Secondary outcome: Safety investigations (physical examination, vital signs and laboratory tests)Pharmacokinetic profile of Cabazitaxel (AUC, Cmax, t1/2, CL, and Vss) from plasma concentration
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 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
For site information, send an email with site number to, Email: Contact-Us@sanofi.com
Investigational Site Number 840013, Loma Linda, California 92354, United States; Recruiting
Investigational Site Number 840014, San Francisco, California 94143, United States; Recruiting
Investigational Site Number 840020, Washington, District of Columbia 20037, United States; Recruiting
Investigational Site Number 840016, Jacksonville, Florida 32207, United States; Recruiting
Investigational Site Number 840002, Tampa, Florida 33612, United States; Completed
Investigational Site Number 840024, Augusta, Georgia 30912, United States; Recruiting
Investigational Site Number 840017, Decatur, Illinois 62526, United States; Recruiting
Investigational Site Number 840022, Indianapolis, Indiana 46202, United States; Recruiting
Investigational Site Number 840003, Metairie, Louisiana 70006, United States; Recruiting
Investigational Site Number 840019, Baltimore, Maryland 21201, United States; Recruiting
Investigational Site Number 840012, Boston, Massachusetts 02115, United States; Recruiting
Investigational Site Number 840004, Detroit, Michigan 48201, United States; Recruiting
Investigational Site Number 840001, St Louis, Missouri 63110, United States; Recruiting
Investigational Site Number 840021, Canton, Ohio 44718, United States; Recruiting
Investigational Site Number 840007, Cincinnati, Ohio 45267-0542, United States; Recruiting
Investigational Site Number 840010, Bethlehem, Pennsylvania 18015, United States; Recruiting
Investigational Site Number 840006, San Antonio, Texas 78229, United States; Recruiting
Additional Information
Starting date: May 2010
Last updated: December 4, 2012
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