A Dose-Escalation Study Of The Safety, Tolerability, And Pharmacokinetics Of Cabazitaxel In Combination With Cisplatin Administered Every 3 Weeks In Subjects With Advanced Solid Malignancies
The total duration on the study per subject will be about 26 weeks broken down as follows:
- A maximum of 21-day screening phase,
- 21-days (+/- 2 weeks) study treatment cycles,
- 30-day follow-up visit after the last dose of study medication.
- Cut-off date for parts 1, 2, 3 and 4: when the last patient has completed 6 cycles
(parts 1 and 2) or 2 cycles (parts 3 and 4) of treatment or discontinued study
treatment (for disease progression, unacceptable toxicity, withdrawal of consent, or
investigator's decision to withdraw), whichever comes first, in the corresponding part.
Patients still receiving treatment at the cut-off date may continue to receive treatment
beyond the cut-off date at investigator's discretion if benefiting.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Dose Limiting Toxicities (DLT)'s of the combination of cabazitaxel and cisplatin (part 1)
first cycle (i.e.3 weeks)
Clinical Sciences & Operations
United States: Food and Drug Administration
|Investigational Site Number 840010||Naperville, Illinois 60540|
|Investigational Site Number 840008||Los Angeles, California 90048|
|Investigational Site Number 840003||San Diego, California 92123|
|Investigational Site Number 840002||Baltimore, Maryland 21201|
|Investigational Site Number 840006||St Louis, Missouri 63110|
|Investigational Site Number 840007||Cincinnati, Ohio 45267-0542|
|Investigational Site Number 840005||San Antonio, Texas 78229|