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To determine the tolerability, maximum tolerated dose and pharmacokinetics of this drug.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
| |
| Arm 2 | Experimental |
| |
| Arm 3 | Experimental |
| |
| Arm 4 | Experimental |
| |
| Arm 5 | Experimental |
| |
| Arm 6 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nexavar (Sorafenib, BAY43-9006) | Drug | Sorafenib 200 mg orally BID interrupted dosing |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary objective of this study is to define the safety profile and maximum tolerated dose (MTD) of BAY43-9006 (sorafenib) administered in combination with, carboplatin, paclitaxel and bevacizumab | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| The secondary objectives include evaluation of pharmacokinetics, biomarkers, pharmacodynamics and tumor response of patients treated with BAY43-9006 (sorafenib) in combination with bevacizumab, paclitaxel and carboplatin | 2 years |
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Inclusion Criteria:
Patients must have Stage IIIB (with malignant pleural effusions) or Stage IV histological or cytological confirmation of non-small cell carcinoma (excluding squamous)
Age >/= 18 years old
Patients must have at least 1 evaluable lesion. Lesions must be evaluated by CT scan or MRI
ECOG Performance Status of 0 to 1
Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to start of first dose:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rochester | Minnesota | 55905 | United States | |||
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| Nexavar (Sorafenib, BAY43-9006) | Drug | Sorafenib 400 mg orally BID interrupted dosing |
|
| Bevacizumab | Drug | Bevacizumab 2.5 mg/kg intravenously |
|
| Bevacizumab | Drug | Bevacizumab 5 mg/kg intravenously |
|
| Bevacizumab | Drug | Bevacizumab 7.5 mg/kg intravenously |
|
| Bevacizumab | Drug | Bevacizumab 10 mg/kg intravenously |
|
| Paclitaxel | Drug | Paclitaxel 200 mg/m² intravenously |
|
| Carboplatin | Drug | Carboplatin AUC 6 intravenously |
|
| Houston |
| Texas |
| 77030 |
| United States |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008175 | Lung Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000077157 | Sorafenib |
| D000068258 | Bevacizumab |
| D017239 | Paclitaxel |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D010671 | Phenylurea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009536 | Niacinamide |
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |
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