Dose Escalating Study With BAY43-9006 With Carboplatin, Paclitaxel and Bevacizumab in Untreated Stage IIIb Non-small Cell Lung Cancer (NSCLC)
NCT ID: NCT01069328
Last Updated: 2013-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
33 participants
INTERVENTIONAL
2006-07-31
2011-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Arm 1
Nexavar (Sorafenib, BAY43-9006)
Sorafenib 200 mg orally BID interrupted dosing
Bevacizumab
Bevacizumab 5 mg/kg intravenously
Paclitaxel
Paclitaxel 200 mg/m² intravenously
Carboplatin
Carboplatin AUC 6 intravenously
Arm 2
Nexavar (Sorafenib, BAY43-9006)
Sorafenib 200 mg orally BID interrupted dosing
Bevacizumab
Bevacizumab 10 mg/kg intravenously
Paclitaxel
Paclitaxel 200 mg/m² intravenously
Carboplatin
Carboplatin AUC 6 intravenously
Arm 3
Nexavar (Sorafenib, BAY43-9006)
Sorafenib 400 mg orally BID interrupted dosing
Bevacizumab
Bevacizumab 2.5 mg/kg intravenously
Paclitaxel
Paclitaxel 200 mg/m² intravenously
Carboplatin
Carboplatin AUC 6 intravenously
Arm 4
Nexavar (Sorafenib, BAY43-9006)
Sorafenib 400 mg orally BID interrupted dosing
Bevacizumab
Bevacizumab 5 mg/kg intravenously
Paclitaxel
Paclitaxel 200 mg/m² intravenously
Carboplatin
Carboplatin AUC 6 intravenously
Arm 5
Nexavar (Sorafenib, BAY43-9006)
Sorafenib 400 mg orally BID interrupted dosing
Bevacizumab
Bevacizumab 7.5 mg/kg intravenously
Paclitaxel
Paclitaxel 200 mg/m² intravenously
Carboplatin
Carboplatin AUC 6 intravenously
Arm 6
Nexavar (Sorafenib, BAY43-9006)
Sorafenib 400 mg orally BID interrupted dosing
Bevacizumab
Bevacizumab 10 mg/kg intravenously
Paclitaxel
Paclitaxel 200 mg/m² intravenously
Carboplatin
Carboplatin AUC 6 intravenously
Interventions
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Nexavar (Sorafenib, BAY43-9006)
Sorafenib 200 mg orally BID interrupted dosing
Nexavar (Sorafenib, BAY43-9006)
Sorafenib 400 mg orally BID interrupted dosing
Bevacizumab
Bevacizumab 2.5 mg/kg intravenously
Bevacizumab
Bevacizumab 5 mg/kg intravenously
Bevacizumab
Bevacizumab 7.5 mg/kg intravenously
Bevacizumab
Bevacizumab 10 mg/kg intravenously
Paclitaxel
Paclitaxel 200 mg/m² intravenously
Carboplatin
Carboplatin AUC 6 intravenously
Eligibility Criteria
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Inclusion Criteria
* 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:
* Hemoglobin \>/= 9.0 g/dL
* White blood cell (WBC) count \>/= 2,500/mm3
* Absolute neutrophil count (ANC) \>/= 1,500/mm3
* Platelet count \>/= 100,000/mm3
* Total bilirubin \</= 1.5 times the upper limit of normal (ULN)
* ALT and AST \</= 2.5 X ULN (\</= 5 X ULN for patients with liver involvement)
* INR \</= 1.5 and aPTT within normal limits
* Serum creatinine \</= ULN or creatinine clearance (CrCl) \>/= 45 mL/min (CrCl = Wt (kg) x (140-age)/72 x Cr level, female x 0.85) for patients with creatinine levels above institutional normal
* Urinalysis (UA) must show less than 1+ protein in urine, or the patient will require a repeat UA. If repeat UA shows 1+ protein or more, a 24 hour urine collection will be required and must show total protein \</= 1000 mg/24 hour to be eligible
Exclusion Criteria
* Cardiac disease: Congestive heart failure \> Class II NYHA; active coronary artery disease (MI more than 6 months prior to study entry is allowed); or serious cardiac ventricular arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted)
* Uncontrolled hypertension defined as systolic blood pressure \> 150 mmHg or diastolic pressure \> 90 mmHg despite optimal medical management
* HIV infection or chronic hepatitis B or C
* Active clinically serious infections (\> Grade 2 NCI-CTC Version 3.0)
* Evidence or history of CNS disease, including primary brain tumors, seizures disorders, or any brain metastasis
18 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Rochester, Minnesota, United States
Houston, Texas, United States
Countries
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Other Identifiers
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11956
Identifier Type: -
Identifier Source: org_study_id