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A Placebo-Controlled Study of Saracatinib (AZD0530) in Patients With Recurrent Osteosarcoma Localized to the Lung
Phase 2
Waitlist Available
Led By Kristin Baird, MD
Research Sponsored by Sarcoma Alliance for Research through Collaboration
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 year overall survival
Summary
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 Saracatinib compared to patients taking placebo (a sugar pill).
Eligible Conditions
- Osteosarcoma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 year overall survival
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 year overall survival
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Progression Free Survival Rate Among Patients Treated With Saracatinib and Placebo.
Secondary study objectives
Biomarkers Related to Activation of Src and Src Substrates
Cell Lines and Murine Xenografts From Recurrent Tumor Samples
Change in Overall Survival With the Addition of Saracatinib to Pulmonary Metastasectomy, Versus Placebo and Pulmonary Metastasectomy
+3 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: SaracatinibActive Control1 Intervention
Saracatinib will be administered as a once daily, oral dose of 175 mg, for a 28-day cycle, with no breaks between cycles. The duration of treatment with saracatinib will be 13 cycles.
Group II: PlaceboPlacebo Group1 Intervention
Placebo will be administered as a once daily, oral dose of 175 mg, for a 28-day cycle, with no breaks between cycles. The duration of treatment with placebo will be 13 cycles.
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Who is running the clinical trial?
Sarcoma Alliance for Research through CollaborationLead Sponsor
25 Previous Clinical Trials
1,916 Total Patients Enrolled
3 Trials studying Osteosarcoma
233 Patients Enrolled for Osteosarcoma
AstraZenecaIndustry Sponsor
4,427 Previous Clinical Trials
289,164,414 Total Patients Enrolled
2 Trials studying Osteosarcoma
82 Patients Enrolled for Osteosarcoma
Kristin Baird, MDPrincipal InvestigatorNational Cancer Institute - Pediatric Oncology Branch