Status:
COMPLETED
A Study to Evaluate the Effects of Combining Cabazitaxel With Cisplatin Given Every 3 Weeks in Patients With Advanced Solid Cancer
Lead Sponsor:
Sanofi
Conditions:
Solid Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This study is designed as a phase 1, multicenter, open-label, single arm, dose-escalation, study of Cabazitaxel in combination with cisplatin, to determine safety, pharmacokinetics (PK), and efficacy ...
Detailed Description
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 vi...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT00925743
Start Date
June 1 2009
End Date
March 1 2013
Last Update
May 16 2013
Active Locations (7)
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1
Investigational Site Number 840008
Los Angeles, California, United States, 90048
2
Investigational Site Number 840003
San Diego, California, United States, 92123
3
Investigational Site Number 840010
Decatur, Illinois, United States, 62526
4
Investigational Site Number 840002
Baltimore, Maryland, United States, 21201