A Study In Patients With Non-Small Cell Lung Cancer Testing If Erlotinib Plus SU011248 (Sunitinib) Is Better Than Erlotinib Alone
NCT00265317
Last updated date
ABOUT THIS STUDY
This study will test whether treatment with erlotinib plus SU011248 is better than erlotinib
alone in patients with advanced/metastatic lung cancer who have received previous treatment
with a platinum-based regimen
Study Location
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
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
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- Patients with locally advanced/metastatic non-small cell lung cancer
- Prior treatment with no more than 2 chemotherapy regimens including a platinum-based regimen
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- Prior treatment with any receptor tyrosine kinase inhibitors, Vascular endothelial
growth factor (VEGF) inhibitors or other angiogenic inhibitors
- History of or known brain metastases
NEED INFO?
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- Oshawa, Ontario
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- Montreal, Quebec
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ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | A Study In Patients With Non-Small Cell Lung Cancer Testing If Erlotinib Plus SU011248 (Sunitinib) Is Better Than Erlotinib Alone | |||
| Official Title ICMJE | Randomized, Double-Blind, Phase 2 Study Of Erlotinib With Or Without SU011248 In The Treatment Of Metastatic Non-Small Cell Lung Cancer | |||
| Brief Summary | This study will test whether treatment with erlotinib plus SU011248 is better than erlotinib alone in patients with advanced/metastatic lung cancer who have received previous treatment with a platinum-based regimen | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 2 | |||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment | |||
| Condition ICMJE | Carcinoma, Non-Small-Cell Lung | |||
| Intervention ICMJE |
| |||
| Study Arms ICMJE |
| |||
| Publications * | Groen HJ, Socinski MA, Grossi F, Juhasz E, Gridelli C, Baas P, Butts CA, Chmielowska E, Usari T, Selaru P, Harmon C, Williams JA, Gao F, Tye L, Chao RC, Blumenschein GR Jr. A randomized, double-blind, phase II study of erlotinib with or without sunitinib for the second-line treatment of metastatic non-small-cell lung cancer (NSCLC). Ann Oncol. 2013 Sep;24(9):2382-9. doi: 10.1093/annonc/mdt212. Epub 2013 Jun 20. | |||
* 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 | 162 | |||
| Original Enrollment ICMJE | 136 | |||
| Actual Study Completion Date ICMJE | January 2012 | |||
| Actual Primary Completion Date | January 2010 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| 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 | Canada, Hungary, Italy, Netherlands, Poland, Romania, Spain, United States | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00265317 | |||
| Other Study ID Numbers ICMJE | A6181058 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Pfizer | |||
| Study Sponsor ICMJE | Pfizer | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
| |||
| PRS Account | Pfizer | |||
| Verification Date | January 2013 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||