check_circleStudy Completed
Neoplasms
Bayer Identifier:
12438
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Sorafenib/Docetaxel Dose Escalation Trial
Trial purpose
The purpose of this study is to: 1.) Evaluate how your body reacts to sorafenib when taken daily (continuously) in combination with docetaxel given every 3 weeks, and to determine the safety of the two drugs together.2.) Measure your blood levels of sorafenib and docetaxel at specific times after taking the medications.
Key Participants Requirements
Sex
BothAge
18 YearsTrial summary
Enrollment Goal
17Trial Dates
November 2007 - March 2009Phase
Phase 1Could I Receive a placebo
NoProducts
Nexavar (Sorafenib, BAY43-9006)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | H. Lee Moffitt Cancer Center & Research Institute | Tampa, 33612, United States |
Completed | Fox Chase Cancer Center | Philadelphia, 19111-2497, United States |
Primary Outcome
- To determine the safety, maximum tolerated dose and dose-limiting toxicities of oral sorafenibdate_rangeTime Frame:6 weeksenhanced_encryptionyesSafety Issue:
Secondary Outcome
- To determine if there is a pharmacokinetic interaction between sorafenib and docetaxel when they are administered togetherdate_rangeTime Frame:6 weeksenhanced_encryptionyesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
Non-randomizedBlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
1