NCT00456716

Brief Summary

Open label study of sorafenib

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_2 lung-cancer

Timeline
Completed

Started Mar 2007

Shorter than P25 for phase_2 lung-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 3, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 5, 2007

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

March 4, 2010

Status Verified

March 1, 2010

Enrollment Period

1.8 years

First QC Date

April 3, 2007

Last Update Submit

March 2, 2010

Conditions

Lung Cancer

Keywords

BAC lung canceradenocarcinoma of the lung

Outcome Measures

Primary Outcomes (3)

  • Response rate

    January 2009

  • One-year survival

    January 2009

  • Median survival

    January 2009

Secondary Outcomes (2)

  • Median progression-free survival

    January 2009

  • Toxicities

    January 2009

Interventions

sorafenibDRUG

400mg po bid

Also known as: BAY 43-9006

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Swedish Cancer Institute

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Lung NeoplasmsAdenocarcinoma of Lung

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Phenylurea CompoundsUreaAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsNiacinamideNicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Howard J West, M.D.

    Swedish Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 3, 2007

First Posted

April 5, 2007

Study Start

March 1, 2007

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

March 4, 2010

Record last verified: 2010-03

Locations

US(1)