Anti-angiogenesis Agent AG-013736 in Patients With Advanced Non-Small Cell Lung Cancer
NCT00094094
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
Adult Trials: 18+ Years
- Histologically documented non-small cell lung cancer with metastases (Stage IV or recurrent disease) or locally advanced (Stage IIIB) with malignant pleural effusion.
- At least 1 prior systemic therapy for metastatic disease (Prior adjuvant therapy for localized disease does not count as a prior therapy for metastatic disease).
- Central lung lesions involving major blood vessels (arteries or veins). (Central
lesions that maintain the structural integrity of vessels have the potential to bleed
if the tumor lesion undergoes necrosis. MRI or CT angiography should be used in any
case where there is any question as to whether blood vessels are involved.)
- Patients with a history of Grade 2 or worse hemoptysis are not eligible. Patients with
a history of Grade 1 hemoptysis within 30 days of entry are not eligible
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Irvine, California
- Orange, California
- Chicago, Illinois
- Park Ridge, Illinois
- Coon Rapids, Minnesota
- Fridley, Minnesota
- Robbinsdale, Minnesota
- Charlotte, North Carolina
- Nashville, Tennessee
- Madison, Wisconsin
- Gauting,
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Anti-angiogenesis Agent AG-013736 in Patients With Advanced Non-Small Cell Lung Cancer | |||
| Official Title ICMJE | Phase 2 Study of the Anti-Angiogenesis Agent AG-013736 as Second- or Later- Line Treatment in Patients With Advanced Non-Small Cell Lung Cancer | |||
| Brief Summary | This is a Phase 2 study being conducted at multiple centers in the United States and Germany. Patients having non-small cell lung cancer that has spread to other parts of the body (i.e., metastatic) or is locally advanced (i.e., Stage IIIB with malignant pleural effusion) are eligible to participate. Patients must have disease that has been treated with at least 1 prior treatment for metastatic disease (prior adjuvant treatment for localized disease does not count as prior treatment for metastatic disease). The purpose of the study is to test whether the angiogenesis inhibitor AG-013736 is an effective treatment for advanced non-small cell lung cancer as shown by the number of patients in the study who experience significant and durable tumor shrinkage | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 2 | |||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
| Condition ICMJE |
| |||
| Intervention ICMJE | Drug: axitinib
Axitinib (AG-013736) tablet administered orally at a dose of 5 milligrams (mg) twice daily (BID) in cycles of 4 weeks. | |||
| Study Arms ICMJE | Experimental: Axitinib
AG-013736 is a vascular endothelial growth factor [VEGF] inhibitor Intervention: Drug: axitinib | |||
| 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 | 32 | |||
| Original Enrollment ICMJE | Not Provided | |||
| Actual Study Completion Date ICMJE | July 2007 | |||
| Actual Primary Completion Date | July 2007 (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 | Germany, United States | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00094094 | |||
| Other Study ID Numbers ICMJE | A4061011 | |||
| Has Data Monitoring Committee | Not Provided | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Not Provided | |||
| Study Sponsor ICMJE | Pfizer | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
| |||
| PRS Account | Pfizer | |||
| Verification Date | June 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||