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Study Of SU011248 In Patients With Metastatic Non-Small Cell Lung Cancer

Last updated on November 21, 2019

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Study Location
Pfizer Investigational Site
Baltimore, Maryland, 21231-1000 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Non-Small-Cell Lung Carcinoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00092001
Pfizer
Completed
Study Of SU011248 In Patients With Metastatic Non-Small Cell Lung Cancer

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[email protected]

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Descriptive Information
Brief Title  ICMJE Study Of SU011248 In Patients With Metastatic Non-Small Cell Lung Cancer
Official Title  ICMJE A Phase 2 Efficacy And Safety Study Of SU011248 In Patients With Metastatic Non-Small Cell Lung Cancer
Brief SummaryThe 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.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Carcinoma, Non-Small-Cell Lung
Intervention  ICMJE Drug: Sunitinib
Sunitinib 50 mg by oral capsule daily for 4 weeks in every 6 week cycle until progression or unacceptable toxicity.
Other Name: Sutent, SU011248
Study Arms  ICMJE Experimental: 1
Intervention: Drug: Sunitinib
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 14, 2006)
111
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE March 2007
Actual Primary Completion DateMarch 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00092001
Other Study ID Numbers  ICMJE A6181040
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer Inc
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateOctober 2008

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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