Phase I Study of Sorafenib Dosed Continuously With Cyclophosphamide and Doxorubicin
- Registration Number
- NCT00562913
- Lead Sponsor
- Bayer
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 21
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm 1 Nexavar (Sorafenib, BAY43-9006) -
- Primary Outcome Measures
Name Time Method To determine the pharmacokinetics and safety of cyclophosphamide when co-administered with 400 mg BID sorafenib and doxorubicin administered 6 weeks
- Secondary Outcome Measures
Name Time Method To evaluate the tumor response to the combination of cyclophosphamide, doxorubicin and sorafenib 6 weeks