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

PHASE1CompletedINTERVENTIONAL
Enrollment

158

Participants

Timeline

Start Date

July 31, 2002

Primary Completion Date

May 31, 2005

Study Completion Date

April 30, 2008

Conditions
Carcinoma
Interventions
DRUG

Sorafenib 100 mg (50-mg tablet)

Sorafenib (Nexavar, BAY43-9006) 100 mg twice daily (50-mg tablet)

DRUG

Sorafenib 200 mg (50-mg tablet)

Sorafenib (Nexavar, BAY43-9006) 200 mg twice daily (50-mg tablet)

DRUG

Sorafenib 400 mg (50-mg tablet)

Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (50-mg tablet)

DRUG

Sorafenib 400 mg (200-mg tablet)

Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet)

DRUG

Sorafenib 400 mg (Expansion)

Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet) expansion

Trial Locations (3)

19104

Philadelphia

37232

Nashville

53792

Madison

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Amgen

INDUSTRY

lead

Bayer

INDUSTRY

NCT00941863 - Study to Determine the Safety, Maximum Tolerated Dose, Pharmacokinetics of Sorafenib (BAY43-9006) | Biotech Hunter | Biotech Hunter