Study of Sorafenib and Gemcitabine in Advanced Hepatocellular Carcinoma (HCC)

PHASE2UnknownINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

September 30, 2008

Primary Completion Date

October 31, 2009

Study Completion Date

December 31, 2009

Conditions
Hepatocellular Carcinoma
Interventions
DRUG

sorafenib

"Patients will be treated with 400 mg oral sorafenib twice a day on a continuous basis. Patients in this protocol may continue to be treated with this combination for a minimum of 4 cycles until any of the following criteria for protocol discontinuation is reached:~1. Progression of disease.~2. The patient is unlikely to benefit from further treatment as~ Judged by the Investigator.~3. Intolerable toxicity of the drugs.~4. Withdrawal of consent for any reason."

DRUG

Gemcitabine

"Patients will be treated with Gemcitabine 1000mg/m2 administered on day 1 \& 8 of a 4 week cycle. Patients in this protocol may continue to be treated with this combination for a minimum of 4 cycles until any of the following criteria for protocol discontinuation is reached:~Progression of disease. The patient is unlikely to benefit from further treatment as~Judged by the Investigator.~Intolerable toxicity of the drugs. Withdrawal of consent for any reason."

Trial Locations (1)

46000

RECRUITING

Combined Military Hospital, Rawalpindi

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bayer

INDUSTRY

lead

Combined Military Hospital, Pakistan

OTHER