A Dose-Escalation, Single Arm, Combination Study of Cabazitaxel With Gemcitabine to Determine The Safety, And Pharmacokinetics In Subjects With Advanced Solid Malignancies
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 2 additional
weeks in case of unresolved toxicity. Patients will be treated until disease progression or
unacceptable toxicities, withdrawal of consent or Investigator's decision.There will be a
30-day follow-up visit after the last dose of study medication. Patients who discontinue
study treatment prior to disease progression will continue to have tumor assessments every 6
weeks until disease progression or start of an other anticancer therapy.
The cut off date for the study is defined as follows: all patients will be followed up until
disease progression, unacceptable toxicity, consent withdrawal or when the last patient had
completed 26 weeks or 6 cycles on study treatment, whichever comes first. Patients may
continue to be treated on study as long as they are benefiting from study treatment and have
not met study withdrawal criteria. After withdrawal from study treatment, further treatment,
if any, is at the discretion of the Investigator.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Part 1: DLTs of the combination of cabazitaxel and gemcitabine
3 weeks (cycle 1)
Yes
Clinical Sciences & Operations
Study Director
Sanofi
United States: Food and Drug Administration
TCD11068
NCT01001221
November 2009
October 2011
Name | Location |
---|---|
Investigational Site Number 840002 | Detroit, Michigan 48201 |
Investigational Site Number 840005 | Cincinnati, Ohio 45267-0542 |
Investigational Site Number 840004 | Philadelphia, Pennsylvania 19111 |
Investigational Site Number 840001 | Nashville, Tennessee 37232 |