Trial Condition(s):

Carcinoma

Study to Determine the Safety, Maximum Tolerated Dose, Pharmacokinetics of Sorafenib (BAY43-9006)

Bayer Identifier:

100375

ClinicalTrials.gov Identifier:

NCT00941863

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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 advanced, refractory solid tumors.

The secondary objectives were evaluation of pharmacokinetics (PK) and tumor response of these patients being treated with sorafenib in combination with paclitaxel and carboplatin.

Inclusion Criteria
- Histologically confirmed solid tumors
- Evaluable disease
- Eastern Cooperative Oncology Group (ECOG) 0 or 1
- Life expectancy minimum 12 weeks
Exclusion Criteria
- 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

Trial Summary

Enrollment Goal
158
Trial Dates
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Phase
1
Could I receive a placebo?
No
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Vanderbilt University Medical School

Nashville, United States, 37232

Status
Completed
 
Locations

University of Wisconsin - Madison

Madison, United States, 53792

Status
Completed
 
Locations

University of Pennsylvania

Philadelphia, United States, 19104

Status
Completed
 

Trial Design