BAY 43-9006 in Previously Untreated Patients With Non-Small Cell Lung Cancer (NSCLC)
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|ClinicalTrials.gov Identifier: NCT00533585|
Recruitment Status : Completed
First Posted : September 21, 2007
Last Update Posted : February 10, 2016
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: BAY 43-9006 Drug: Paclitaxel Drug: Carboplatin Drug: Bevacizumab||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Dose-Escalating, Open-Label, Non-Placebo Controlled Study of BAY 43-9006 (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 Start Date :||May 2006|
|Actual Primary Completion Date :||January 2016|
|Actual Study Completion Date :||January 2016|
Experimental: BAY 43-9006 + Bevacizumab
BAY 43-9006 (Sorafenib) + Bevacizumab + Paclitaxel + Carboplatin
Drug: BAY 43-9006
Starting Dose of 200 mg orally twice a day on Day 3 through Day 19 of Cycle 1 and Days 2 through 19 of Cycle 2 and remaining cycles. Cycle is 21 days.
Other Name: Sorafenib
200 mg/m^2 By Vein Over 3 Hours on Day 1.
Other Name: Taxol
Area under curve (AUC) 6 By Vein Over 30 Minutes on Day 1.
Other Name: Paraplatin
Starting Dose of 5 mg/kg By Vein Over 90 minutes on Day 1.
- Maximum Tolerated Dose (MTD) of BAY 43-9006 (sorafenib) and Bevacizumab in Combination with Carboplatin and Paclitaxel [ Time Frame: First day of every 21 day cycle ]If a dose limiting toxicity (DLT) occurs in ≥ 2 out of 6 patients at dose levels 2 - 6, dose escalation will be stopped and that dose will be declared the toxic dose. The dose level below will be declared the maximum tolerated dose if at this dose level 6 patients can be treated such that no more than 1 patient experiences a DLT.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00533585
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||George Blumenschein, MD||M.D. Anderson Cancer Center|