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
18 Years
N/A
Both
Solid Cancer
Trial Information
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.
Inclusion Criteria
Inclusion criteria:
- confirmed metastatic or unremovable advanced solid malignancy that is metastatic or
unresectable, and for which standard curative measures do not exist, but for which
cisplatin based therapy is appropriate
- signed informed consent
Exclusion criteria
- limited physical functioning (as evaluated by the Eastern Cooperative Oncology Group
(ECOG) scale)
- inability to follow study requirements and schedule
- treatment of cancer within 3 weeks of study, concurrent treatment in another clinical
trial or with any other cancer therapy
- serious medical illness at same time of study and/or significantly abnormal lab
reports
- lack of pregnancy contraception (women of childbearing potential), pregnancy, or
breast feeding.
- Women of childbearing potential not protected by highly effective contraceptive
method of birth control OTHER than hormonal contraception (Part 4 only).
- prior significant hearing or kidney problems
- continued toxic effects of prior chemotherapy
- cancers that cannot be physically measured (Part 2 only)
The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Dose Limiting Toxicities (DLT)'s of the combination of cabazitaxel and cisplatin (part 1)
Outcome Time Frame:
first cycle (i.e.3 weeks)
Safety Issue:
Yes
Principal Investigator
Clinical Sciences & Operations
Investigator Role:
Study Director
Investigator Affiliation:
Sanofi
Authority:
United States: Food and Drug Administration
Study ID:
TCD10870
NCT ID:
NCT00925743
Start Date:
June 2009
Completion Date:
March 2013
Related Keywords:
- Solid Cancer
- Phase 1
- XRP6258
- cisplatin
- Antineoplastic Combined Chemotherapy Protocols
Name | Location |
|---|---|
| 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 |
