BAY 43-9006 in Previously Untreated Patients With Non-Small Cell Lung Cancer (NSCLC)
Part of paid clinical trials in Houston, Texas.
- Sponsor
- M.D. Anderson Cancer Center
- Study ID
- NCT00533585
- Phase
- PHASE1
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- BAY 43-9006 — DRUGStarting 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.
- Paclitaxel — DRUG200 mg/m\^2 By Vein Over 3 Hours on Day 1.
- Carboplatin — DRUGArea under curve (AUC) 6 By Vein Over 30 Minutes on Day 1.
- Bevacizumab — DRUGStarting Dose of 5 mg/kg By Vein Over 90 minutes on Day 1.
Study Details
The goal of this study is to find the highest tolerable dose of BAY 43-9006 (sorafenib) and bevacizumab that can be given with paclitaxel and carboplatin in patients with non-small cell lung cancer (NSCLC). The safety and effectiveness of this drug combination will also be studied.
Key Dates
- First listed
- Sep 21, 2007
- Start date
- May 31, 2006
- Status verified
- Feb 2016
- Primary completion
- Jan 31, 2016
- Completion
- Jan 31, 2016
Study Design
- Enrollment
- 23 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: BAY 43-9006 + BevacizumabBAY 43-9006 (Sorafenib) + Bevacizumab + Paclitaxel + Carboplatin
Primary Outcome Measure
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 ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | - |
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