NCT00092001

Brief Summary

The purpose of this study is to test whether SU011248 has activity and is safe in patients with metastatic non-small cell lung cancer (NSCLC) who have failed a platinum-containing regimen and docetaxel.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
111

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2005

Geographic Reach
3 countries

14 active sites

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

First Submitted

Initial submission to the registry

September 21, 2004

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 27, 2004

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2005

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

October 16, 2008

Status Verified

October 1, 2008

Enrollment Period

2.2 years

First QC Date

September 21, 2004

Last Update Submit

October 15, 2008

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

Non-small cell lung cancer, carcinoma, sunitinib, Phase 2

Outcome Measures

Primary Outcomes (1)

  • Overall confirmed objective response rate (ORR)

    From screening until at least 28 days beyond discontinuation of study treatment.

Secondary Outcomes (5)

  • Progression-free survival (PFS)

    From screening until disease progression or discontinuation of study

  • Time to progression (TTP)

    From screening until disease progression or discontinuation of study

  • Duration of response (DR)

    From screening until disease progression or discontinuation of study

  • Overall survival (OS)

    From screening until disease progression or discontinuation of study

  • Probability of survival at 1 year

    From screening until disease progression or discontinuation of study

Study Arms (1)

1

EXPERIMENTAL
Drug: Sunitinib

Interventions

SunitinibDRUG

Sunitinib 50 mg by oral capsule daily for 4 weeks in every 6 week cycle until progression or unacceptable toxicity.

Also known as: Sutent, SU011248
1

Eligibility Criteria

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

You may qualify if:

  • Histologically confirmed advanced or metastatic Non-Small Cell Lung Cancer that cannot be cured with surgery, radiation, or combination thereof
  • No more than 2 prior chemotherapy treatments including treatment with a platinum containing therapy
  • Evidence of measurable disease by radiographic technique
  • Male or Female, 18 years or older
  • ECOG performance status of 0 or 1
  • Resolution of all acute toxicities of prior therapies
  • Adequate organ function

You may not qualify if:

  • Major surgery or radiation therapy within 4 weeks
  • Severe hemorrhage within 4 weeks
  • Previous treatment with anti-angiogenesis agents
  • Diagnosis of second malignancy within last five 5 years
  • History of or known brain metastases, spinal cord compression, or carcinomatous meningitis
  • Known HIV
  • Serious acute or chronic illness
  • Current treatment on another clinical trial
  • Pregnant or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Pfizer Investigational Site

Baltimore, Maryland, 21231-1000, United States

Location

Pfizer Investigational Site

City of Saint Peters, Missouri, 63376, United States

Location

Pfizer Investigational Site

St Louis, Missouri, 63110-1094, United States

Location

Pfizer Investigational Site

St Louis, Missouri, 63110, United States

Location

Pfizer Investigational Site

Chapel Hill, North Carolina, 27599-7600, United States

Location

Pfizer Investigational Site

Clinton, North Carolina, 28382, United States

Location

Pfizer Investigational Site

Goldsboro, North Carolina, 27534, United States

Location

Pfizer Investigational Site

Pollocksville, North Carolina, 28573, United States

Location

Pfizer Investigational Site

Wilson, North Carolina, 27893, United States

Location

Pfizer Investigational Site

Pittsburgh, Pennsylvania, 15232, United States

Location

Pfizer Investigational Site

Charlottesville, Virginia, 22908, United States

Location

Pfizer Investigational Site

Orbassano (Torino), 10043, Italy

Location

Pfizer Investigational Site

Badalona, Barcelona, 08916, Spain

Location

Pfizer Investigational Site

Barcelona, BARCELONA, 08025, Spain

Location

Related Links

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungCarcinoma

Interventions

Sunitinib

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

September 21, 2004

First Posted

September 27, 2004

Study Start

January 1, 2005

Primary Completion

March 1, 2007

Study Completion

March 1, 2007

Last Updated

October 16, 2008

Record last verified: 2008-10

Locations

US(11)IT(1)ES(2)