Dose Escalating Study With BAY43-9006 With Carboplatin, Paclitaxel and Bevacizumab in Untreated Stage IIIb Non-small Cell Lung Cancer (NSCLC)
Primary Purpose
Carcinoma, Non-Small-Cell Lung, Lung Cancer
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Nexavar (Sorafenib, BAY43-9006)
Nexavar (Sorafenib, BAY43-9006)
Bevacizumab
Bevacizumab
Bevacizumab
Bevacizumab
Paclitaxel
Carboplatin
Sponsored by
About this trial
This is an interventional basic science trial for Carcinoma, Non-Small-Cell Lung focused on measuring Lung, cancer, NSCLC
Eligibility Criteria
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:
- 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:
- Patients with squamous histology
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01069328
Brief Title
Dose Escalating Study With BAY43-9006 With Carboplatin, Paclitaxel and Bevacizumab in Untreated Stage IIIb Non-small Cell Lung Cancer (NSCLC)
Official Title
Study of BAY43-9006 (Sorafenib) in Combination With Carboplatin, Paclitaxel and Bevacizumab in Previously Untreated Patients With Stage IIIB (With Malignant Pleural Effusions) or Stage IV Non-small Cell Lung Cancer (NSCLC)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
October 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To determine the tolerability, maximum tolerated dose and pharmacokinetics of this drug.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Non-Small-Cell Lung, Lung Cancer
Keywords
Lung, cancer, NSCLC
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Title
Arm 2
Arm Type
Experimental
Arm Title
Arm 3
Arm Type
Experimental
Arm Title
Arm 4
Arm Type
Experimental
Arm Title
Arm 5
Arm Type
Experimental
Arm Title
Arm 6
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Nexavar (Sorafenib, BAY43-9006)
Intervention Description
Sorafenib 200 mg orally BID interrupted dosing
Intervention Type
Drug
Intervention Name(s)
Nexavar (Sorafenib, BAY43-9006)
Intervention Description
Sorafenib 400 mg orally BID interrupted dosing
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Intervention Description
Bevacizumab 2.5 mg/kg intravenously
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Intervention Description
Bevacizumab 5 mg/kg intravenously
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Intervention Description
Bevacizumab 7.5 mg/kg intravenously
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Intervention Description
Bevacizumab 10 mg/kg intravenously
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
Paclitaxel 200 mg/m² intravenously
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Carboplatin AUC 6 intravenously
Primary Outcome Measure Information:
Title
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
Time Frame
2 years
Secondary Outcome Measure Information:
Title
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
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
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:
Patients with squamous histology
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Dose Escalating Study With BAY43-9006 With Carboplatin, Paclitaxel and Bevacizumab in Untreated Stage IIIb Non-small Cell Lung Cancer (NSCLC)
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