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Anti-angiogenesis Agent AG-013736 in Patients With Advanced Non-Small Cell Lung Cancer

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Irvine, California, 92612 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Lung Neoplasms, 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 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).

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

- 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

NCT00094094
Pfizer
Completed
Anti-angiogenesis Agent AG-013736 in Patients With Advanced Non-Small Cell Lung Cancer

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Anti-angiogenesis Agent AG-013736 in Patients With Advanced Non-Small Cell Lung Cancer
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
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
Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Lung Neoplasms
  • Carcinoma, Non-small Cell Lung
Drug: axitinib
Axitinib (AG-013736) tablet administered orally at a dose of 5 milligrams (mg) twice daily (BID) in cycles of 4 weeks.
Experimental: Axitinib
AG-013736 is a vascular endothelial growth factor [VEGF] inhibitor
Intervention: Drug: axitinib
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
July 2007
July 2007   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany,   United States
 
 
NCT00094094
A4061011
Not Provided
Not Provided
Not Provided
Not Provided
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2012

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 thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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