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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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11 March 2013 |
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Main ID: |
NCT01262820 |
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Date of registration:
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07/12/2010 |
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Primary sponsor: |
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Public title:
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Pazopanib In Stage IIIB/IV NSCLC Lung Cancer After Progression on First Line Therapy Containing Bevacizumab
LCCC0921 |
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Scientific title:
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A Multi-Center Open Label Phase II Study of Pazopanib in Stage IIIB/IV Non-Squamous Non-Small Cell Lung Cancer After Progression on First Line Therapy Containing Bevacizumab |
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Date of first enrolment:
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December 2010 |
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Target sample size:
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36 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01262820 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Maureen Tynan, RN |
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Address:
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Telephone:
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919-966-4432 |
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Email:
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tynanm@med.unc.edu |
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Affiliation:
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Name:
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Donna Rowe, RN |
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Address:
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Telephone:
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(919) 966-7359 |
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Email:
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donna_rowe@med.unc.edu |
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Affiliation:
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Name:
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Thomas Stinchcombe, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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North Carolina Cancer Hospital at University of NC at Chapel Hill |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age 18 or older
- Stage IIIB (with malignant pleural or pericardial effusion or supraclavicular lymph
node involvement) or stage IV NSCLC
- Evidence of progression while on bevacizumab
- Patients treated for CNS metastases who are asymptomatic with no requirement for
steroids for 2 weeks prior to first dose of study drug
Exclusion Criteria:
- Prior malignancy
- Clinically significant gastrointestinal abnormalities
- Presence of uncontrolled infection or nonhealing wound, fracture, or ulcer
- History of cardiovascular conditions within the past 6 months
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Lung Cancer
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Intervention(s)
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Drug: Pazopanib
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Primary Outcome(s)
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Best overall response and progression free survival
[Time Frame: Eight (8) months w additional time for response date to mature]
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Secondary Outcome(s)
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Estimate combined response rate CR + PF of pazopanib according to RECIST
[Time Frame: 8 months with additional time for response to mature]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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