Dose Escalating Study With BAY43-9006 With Carboplatin, Paclitaxel and Bevacizumab in Untreated Stage IIIb Non-small Cell Lung Cancer (NSCLC)

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Bayer
Study ID
NCT01069328
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nexavar (Sorafenib, BAY43-9006) — DRUG
    Sorafenib 200 mg orally BID interrupted dosing
  • Nexavar (Sorafenib, BAY43-9006) — DRUG
    Sorafenib 400 mg orally BID interrupted dosing
  • Bevacizumab — DRUG
    Bevacizumab 2.5 mg/kg intravenously
  • Bevacizumab — DRUG
    Bevacizumab 5 mg/kg intravenously
  • Bevacizumab — DRUG
    Bevacizumab 7.5 mg/kg intravenously
  • Bevacizumab — DRUG
    Bevacizumab 10 mg/kg intravenously
  • Paclitaxel — DRUG
    Paclitaxel 200 mg/m² intravenously
  • Carboplatin — DRUG
    Carboplatin AUC 6 intravenously

Study Details

To determine the tolerability, maximum tolerated dose and pharmacokinetics of this drug.

Key Dates

First listed
Feb 17, 2010
Start date
Jul 31, 2006
Status verified
Nov 2013
Primary completion
Sep 30, 2011
Completion
Oct 31, 2011

Study Design

Enrollment
33 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Arm 1
  • Experimental: Arm 2
  • Experimental: Arm 3
  • Experimental: Arm 4
  • Experimental: Arm 5
  • Experimental: Arm 6

Primary Outcome Measure

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 ]

Locations (2)

FacilityCityStateZIPSite coordinators
-RochesterMinnesota55905-
-HoustonTexas77030-

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By specialty
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