Status:
COMPLETED
Study to Determine the Safety, Maximum Tolerated Dose, Pharmacokinetics of Sorafenib (BAY43-9006)
Lead Sponsor:
Bayer
Collaborating Sponsors:
Amgen
Conditions:
Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The primary objective of the study was to define the safety profile and maximum tolerated dose (MTD) of sorafenib tablets in combination with carboplatin and paclitaxel chemotherapy in patients with a...
Eligibility Criteria
Inclusion
- Histologically confirmed solid tumors
- Evaluable disease
- Eastern Cooperative Oncology Group (ECOG) 0 or 1
- Life expectancy minimum 12 weeks
Exclusion
- Congestive heart failure
- Serious arrhythmias
- Coronary artery disease (CAD) or ischemia
- HIV (human immunodeficiency virus)
- Hepatitis B or C
- Serious active infection
- Metastatic brain or meningeal tumors
Key Trial Info
Start Date :
July 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
158 Patients enrolled
Trial Details
Trial ID
NCT00941863
Start Date
July 1 2002
End Date
April 1 2008
Last Update
March 22 2016
Active Locations (3)
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1
Philadelphia, Pennsylvania, United States, 19104
2
Nashville, Tennessee, United States, 37232
3
Madison, Wisconsin, United States, 53792