Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Sarcoma Alliance for Research through Collaboration AstraZeneca |
---|---|
Information provided by: | Sarcoma Alliance for Research through Collaboration |
ClinicalTrials.gov Identifier: | NCT00752206 |
The purpose of this study is to determine how long patients who undergo complete surgical removal of recurrent osteosarcoma in the lung will remain free of cancer after taking AZD0530 compared to patients taking placebo (a sugar pill).
Condition | Intervention | Phase |
---|---|---|
Osteosarcoma |
Drug: AZD0530 Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blinded, Placebo-Controlled, Multi-Institutional, Phase II.5 Study of AZD0530, a Selective Src Kinase Inhibitor, In Patients With Recurrent Osteosarcoma Localized to the Lung |
Estimated Enrollment: | 88 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | September 2014 |
Estimated Primary Completion Date: | September 2014 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator |
Drug: AZD0530
Oral Agent
|
2: Placebo Comparator |
Drug: Placebo
Oral Agent
|
Further details provided by SARC (Sarcoma Alliance for Research through Collaboration):
After complete surgical removal of their cancer, patients will be randomly assigned to receive either AZD0530 or placebo (a sugar pill) throughout the study. Patients will take AZD0530 (or placebo) once daily by mouth for a total of 364 days. The duration of treatment is divided into 13 cycles, 28 days each cycle with no breaks in between.
Patients will be seen for interim medical history, physical exam and laboratory studies prior to each cycle. To monitor for recurrence of tumor, patients will undergo thoracic CT scans at 3-4 weeks, 6-8 weeks, at 3 months, at 6 months, at 9 months, at 12 months, then every 6 months up to 2 years, and then every year up to 5 years after starting treatment. An electrocardiogram (ECG) will be taken at 3 months, and a bone scan will be performed at 12 months.
Blood and tumor samples for research purposes will be collected at the time the tumor is removed.
After completing all 13 cycles, patients will be followed for approximately every 3 months until 2 years from starting treatment, then approximately every 6 months until 4 years from starting treatment, and once at year 5.
Ages Eligible for Study: | 15 Years to 74 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Denise Reinke, MS, NP, President | 734-930-7600 | sarc@sarctrials.org |
Contact: Kathleen Granlund | 734-930-7607 | kegranlund@sarctrials.org |
United States, California | |
Cedars-Sinai Outpatient Cancer Center | |
Los Angeles, California, United States | |
Stanford University | |
Palo Alto, California, United States | |
United States, Iowa | |
University of Iowa Hospitals and Clinics | |
Iowa City, Iowa, United States | |
United States, Maryland | |
National Cancer Institute | |
Bethesda, Maryland, United States, 20892 | |
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center | |
Baltimore, Maryland, United States | |
United States, Minnesota | |
University of Minnesota | |
Minneapolis, Minnesota, United States | |
United States, New York | |
Memorial Sloan Kettering Cancer Center | |
New York, New York, United States | |
United States, North Carolina | |
Carolinas Hematology Oncology Associates | |
Charlotte, North Carolina, United States | |
United States, Pennsylvania | |
Pennsylvania Hematology Oncology Associates | |
Philadelphia, Pennsylvania, United States | |
University of Pittsburgh Cancer Institute | |
Pittsburgh, Pennsylvania, United States | |
United States, Texas | |
MD Anderson | |
Houston, Texas, United States |
Principal Investigator: | Lee J Helman, MD | National Cancer Institute - Pediatric Oncology Branch |
Responsible Party: | SARC (Sarcoma Alliance for Research through Collaboration) ( Denise Reinke, MS, NP / President ) |
Study ID Numbers: | SARC012, D8180C00039 |
Study First Received: | September 11, 2008 |
Last Updated: | December 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00752206 |
Health Authority: | United States: Food and Drug Administration |
AZD0530 Osteosarcoma Recurrent |
Osteosarcoma Localized to the Lung |
Neoplasms, Connective and Soft Tissue Malignant mesenchymal tumor Sarcoma Osteosarcoma |
Osteogenic sarcoma Soft tissue sarcomas Recurrence |
Neoplasms Neoplasms by Histologic Type Neoplasms, Bone Tissue Neoplasms, Connective Tissue |