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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Page 1 of 1 (3 locations)

1

Philadelphia, Pennsylvania, United States, 19104

2

Nashville, Tennessee, United States, 37232

3

Madison, Wisconsin, United States, 53792