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

Completed · Phase 1

Conditions studied: Carcinoma

In brief

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.

Key facts

Study ID

NCT00941863

Run by

Bayer

People needed

158

Starts

2002-07-01

Expected to finish

2008-04-01

Last updated by the study team

2016-03-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Study site — Philadelphia, Pennsylvania, United States
• Study site — Nashville, Tennessee, United States
• Study site — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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