Phase I Study of Sorafenib Dosed Continuously With Cyclophosphamide and Doxorubicin

Bayer

Status and phase: Completed; Phase 1

Conditions: Cancer

Treatments: Drug: Nexavar (Sorafenib, BAY43-9006)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00562913

12347

Details and patient eligibility

About

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

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

Arm 1

Experimental group

Treatment:

Drug: Nexavar (Sorafenib, BAY43-9006)