Phase I Safety and Pharmacokinetic Study of XRP6258 (Cabazitaxel) In Advanced Solid Tumor Patients With Varying Degrees of Hepatic Impairment
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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Incidence of Dose Limiting Toxicities (DLT)
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.
cycle 1 (3 weeks)
Yes
Clinical Sciences & Operations
Study Director
Sanofi
United States: Food and Drug Administration
POP6792
NCT01140607
May 2010
May 2014
Name | Location |
---|---|
Investigational Site Number 840007 | Cincinnati, Ohio 45267-0542 |
Investigational Site Number 840013 | Loma Linda, California 92354 |
Investigational Site Number 840014 | San Francisco, California 94143 |
Investigational Site Number 840020 | Washington, District of Columbia 20037 |
Investigational Site Number 840016 | Jacksonville, Florida 32207 |
Investigational Site Number 840002 | Tampa, Florida 33612 |
Investigational Site Number 840017 | Decatur, Illinois 62526 |
Investigational Site Number 840003 | Metairie, Louisiana 70006 |
Investigational Site Number 840019 | Baltimore, Maryland 21201 |
Investigational Site Number 840012 | Boston, Massachusetts 02115 |
Investigational Site Number 840001 | St Louis, Missouri 63110 |
Investigational Site Number 840021 | Canton, Ohio 44718 |
Investigational Site Number 840010 | Bethlehem, Pennsylvania 18015 |
Investigational Site Number 840006 | San Antonio, Texas 78229 |
Investigational Site Number 840024 | Augusta, Georgia 30912 |
Investigational Site Number 840022 | Indianapolis, Indiana 46202 |
Investigational Site Number 840004 | Detroit, Michigan 48201 |