Phase II Study of Cediranib (AZD2171) in Patients With Alveolar Soft Part Sarcoma
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|ClinicalTrials.gov Identifier: NCT00942877|
Recruitment Status : Active, not recruiting
First Posted : July 21, 2009
Last Update Posted : May 8, 2020
- Alveolar soft part sarcoma is a type of cancer that develops in tissues that connect, support, or surround other organs in the body. It relies heavily on new blood vessels to grow and spread through the body. There is no effective systemic treatment for patients with alveolar soft part sarcoma.
- The drug AZD2171 (cediranib) is an experimental drug, not yet approved by the Food and Drug Administration. The drug blocks the creation of new blood vessels. The drug has had initial clinical trials, and researchers are interested in determining whether cediranib is effective in inhibiting tumor growth in individuals who have alveolar soft part sarcoma.
- To find out whether AZD2171 works in patients who have alveolar soft part sarcoma.
- Individuals 18 years of age and older who have been diagnosed with alveolar soft part sarcoma.
- After an initial screening visit, patients will take AZD2171 by mouth once a day, every day for the duration of the study. The treatment will be given in 28-day cycles.
- Patients will keep a study diary to record the doses taken, any missed doses, and any side effects.
- Patients will have the following tests and procedures during the treatment period: clinic visit with physical examination every 2 weeks, regular blood pressure monitoring, blood and urine tests, heart function tests, imagining scans to evaluate tumor size and response to the treatment, and possible tumor biopsy.
|Condition or disease||Intervention/treatment||Phase|
|Sarcoma, Alveolar Soft Part||Drug: AZD2171||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||53 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Cediranib (AZD2171) in Patients With Alveolar Soft Part Sarcoma|
|Actual Study Start Date :||September 1, 2009|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||December 31, 2020|
Pediatric patients (<16 years old) will be treated with 12 mg/m2/day once a day for 28 days (28-day cycles).
Cediranib (AZD2171), a VEGF/KIT tyrosine kinase inhibitor, has demonstrated antitumor activity in early phase clinical trials in adult and pediatric patients with ASPS.
- Response rate [ Time Frame: 2 cycles ]To determine if pediatric patients with ASPS will experience at least a minimal response rate when treated with AZD2171
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00942877
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Alice P Chen, M.D.||National Cancer Institute (NCI)|