Phase I Study of Sorafenib Dosed Continuously With Cyclophosphamide and Doxorubicin

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Study to access the safety, levels of drug in the blood and tumor effects of sorafenib dosed daily combined with Cyclophosphamide and Doxorubicin in cancer patients

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Treatments: Cyclophosphamide; Doxorubicin; Liposomal doxorubicin; Niacinamide; Sorafenib

Criteria

Inclusion Criteria:

• At least 18 years old

• Advanced histological or cytological documentation of cancer

• life-expectancy of at least 12 weeks

• able to swallow pills

• ECOG status of 0,1 or 2

• adequate bone marrow

• liver and renal function

Exclusion Criteria:

• > NYHA Class 2 CHF

• Serious myocardial dysfunction,

• or symptomatic coronary artery disease (MI more than 6 months prior to study entry is allowed)

• History of organ allograft

• uncontrolled hypertension

• renal dialysis

• Bleeding event/hemorrhage within 4 weeks of study treatment

• major surgery within 4 weeks of study treatment

• Previous exposure to doxorubicin or other anthracyclines exceeding a maximum lifetime cumulative dose