Dose Escalating Study With BAY43-9006 With Carboplatin, Paclitaxel and Bevacizumab in Untreated Stage IIIb Non-small Cell Lung Cancer (NSCLC)
NCT01069328 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 33
Last updated 2013-11-13
Summary
To determine the tolerability, maximum tolerated dose and pharmacokinetics of this drug.
Conditions
- Carcinoma, Non-Small-Cell Lung
- Lung Cancer
Interventions
- DRUG
-
Nexavar (Sorafenib, BAY43-9006)
Sorafenib 200 mg orally BID interrupted dosing
- DRUG
-
Nexavar (Sorafenib, BAY43-9006)
Sorafenib 400 mg orally BID interrupted dosing
- DRUG
-
Bevacizumab 2.5 mg/kg intravenously
- DRUG
-
Bevacizumab 5 mg/kg intravenously
- DRUG
-
Bevacizumab 7.5 mg/kg intravenously
- DRUG
-
Bevacizumab 10 mg/kg intravenously
- DRUG
-
Paclitaxel 200 mg/m² intravenously
- DRUG
-
Carboplatin AUC 6 intravenously
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Bayer Study Director · Bayer
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2006-07-31
- Primary Completion
- 2011-09-30
- Completion
- 2011-10-31
Countries
- United States
Study Locations
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