NCT00430261

Brief Summary

This is an open-label study of a new oral drug for advanced stage (IIIB or IV) lung cancer. The cancer must be EITHER bronchoalveolar carcinoma (BAC) type, or if the patient is a never-smoker (less than 100 cigarettes lifetime) the cancer can be any type of adenocarcinoma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_2 lung-cancer

Timeline
Completed

Started Jan 2007

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

January 1, 2007

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

January 30, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 1, 2007

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

October 6, 2010

Status Verified

October 1, 2010

Enrollment Period

3.8 years

First QC Date

January 30, 2007

Last Update Submit

October 5, 2010

Conditions

Lung CancerAdenocarcinoma

Keywords

bronchoalveolar carcinomaBACadenocarcinomalung canceroralStage IIIB and IV lung cancerAny bronchoalveolar carcinoma (BAC)Any adenocarcinoma in a never-smoker

Outcome Measures

Primary Outcomes (1)

  • Progression-Free Survival

    January 2009

Interventions

sunitinibDRUG

50mg po qd x 4 weeks on followed by 2 weeks off for a 6 week cycle.

Also known as: SU011248

Eligibility Criteria

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

You may qualify if:

  • Bronchoalveolar carcinoma with disease measurable on CAT scan
  • Any lung adenocarcinoma in a never-smoker (less than 100 cigarettes lifetime) with disease measurable on CAT scan
  • Stage IIIB or IV

You may not qualify if:

  • Uncontrolled hypertension
  • Unstable brain metastases
  • Pregnant/nursing women
  • Uncontrolled thyroid disease

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 NeoplasmsAdenocarcinomaAdenocarcinoma, Bronchiolo-Alveolar

Interventions

Sunitinib

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeAdenocarcinoma of Lung

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Howard 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

January 30, 2007

First Posted

February 1, 2007

Study Start

January 1, 2007

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

October 6, 2010

Record last verified: 2010-10

Locations

US(1)