check_circleStudy Completed
Neoplasms
Bayer Identifier:
11988
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Sorafenib/ Carboplatin/ Paclitaxel in patients with solid tumors
Trial purpose
The purpose of this study is to:
1.) Evaluate how the body reacts to sorafenib when taken daily in combination with paclitaxel and carboplatin,
2.) Measure the blood levels of sorafenib, paclitaxel and carboplatin at specific times after taking the medication, and
3.) To determine the safety of sorafenib.
1.) Evaluate how the body reacts to sorafenib when taken daily in combination with paclitaxel and carboplatin,
2.) Measure the blood levels of sorafenib, paclitaxel and carboplatin at specific times after taking the medication, and
3.) To determine the safety of sorafenib.
Key Participants Requirements
Sex
BothAge
18 - N/ATrial summary
Enrollment Goal
16Trial Dates
May 2007 - February 2009Phase
Phase 1Could I Receive a placebo
NoProducts
Nexavar (Sorafenib, BAY43-9006)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Yale Cancer Center | New Haven, 06511-5991, United States |
Completed | South Texas Accelerated Research Therapeutics | San Antonio, 78229-3307, United States |
Primary Outcome
- Safety and pharmacokinetics of the three agents: sorafenib administered daily, without a break in dosing, in combination with carboplatin and paclitaxel, administered every 3 weeksdate_rangeTime Frame:2 yearsenhanced_encryptionnoSafety Issue:
Secondary Outcome
- To determine the safety profile and pharmacokinetics of oral sorafenib daily in combination with every 3-weekly carboplatin and paclitaxel.date_rangeTime Frame:2 yearsenhanced_encryptionnoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
Non-randomizedBlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
1