Sorafenib in BAC or Never-Smokers With Lung Adenocarcinoma

NCT ID: NCT00456716

Last Updated: 2010-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2008-12-31

Brief Summary

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Open label study of sorafenib

Detailed Description

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Open label study using oral sorafenib 800 mg daily in any stage III-IV BAC lung cancer and Stage III-IV adenocarcinoma of the lung in nonsmokers (less than \< 100 cigarettes lifetime).

Conditions

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Lung Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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sorafenib

400mg po bid

Intervention Type DRUG

Other Intervention Names

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BAY 43-9006

Eligibility Criteria

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Inclusion Criteria

* Age \> 18
* Life expectancy \> 12 weeks
* Biopsy-proven BAC or adenocarcinoma
* Willing to provide smoking status
* Selected IIIB or stage IV cancer that is incompletely resected or unresectable

Exclusion Criteria

* O2 saturation \< 88% on room air
* Pregnant or nursing women
* Surgery or radiation therapy within 4 weeks of starting study
* Major heart condition within 6 months of starting therapy
* Certain concomitant medications prohibited
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role collaborator

Amgen

INDUSTRY

Sponsor Role collaborator

Swedish Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Swedish Medical Center, Swedish Cancer Institute

Principal Investigators

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Howard J West, M.D.

Role: PRINCIPAL_INVESTIGATOR

Swedish Cancer Institute

Locations

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Swedish Cancer Institute

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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CRC 0639

Identifier Type: -

Identifier Source: org_study_id

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