A Randomized, Double-Blinded, Placebo-Controlled, Multi-Institutional, Phase II.5 Study of Saracatinib (AZD0530), a Selective Src Kinase Inhibitor, in Patients With Recurrent Osteosarcoma Localized to the Lung
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Kristin Baird, M.D.
1-877-624-4878 (Toll free)
- Saracatinib is a potent and selective Src kinase inhibitor
- In vitro studies demonstrate that 95 percent of patients with osteosarcoma have activation of Src or one of its substrates
- A Phase I study of saracatinib given daily in adult patients with advanced solid malignancies has identified 175 mg as the maximum tolerated dose
- Determine if the addition of saracatinib to pulmonary metastasectomy versus placebo and pulmonary metastasectomy results in an increase in progression free survival
- Secondary objectives:
- Determine if the addition of saracatinib to pulmonary metastasectomy versus placebo and pulmonary metastasectomy results in an increase in overall survival
- Determine if the addition of saracatinib to pulmonary metastasectomy versus placebo and pulmonary metastasectomy results in an increase in time-to-treatment failure, defined as a composite endpoint measuring time from randomization to discontinuation of treatment for any reason, including disease progression, treatment toxicity, or death
- Perform microarray analysis of tumor samples to identify a gene signature that predicts for recurrence of osteosarcoma
- Evaluate tumor samples for biomarkers related to activation of Src and Src substrates
- Establish cell lines and murine xenografts from recurrent tumor samples
- Perform sequencing analysis of DNA and RNA in tumor samples compared to normal blood to detect mutations that may be causative for recurrent osteosarcoma
Key Eligibility Criteria:
- Patients > 15 and < 75 years of age with suspected recurrence of osteosarcoma, localized to the lung, are eligible for enrollment
- Patients with histological confirmation of recurrent osteosarcoma, localized to the lung, who have had complete surgical removal of all lung nodules, will be eligible for randomization
- After complete resection of all lung nodules, patients will be randomized to treatment with saracatinib or placebo
- Eighty-eight patients will be randomized, 44 patients in each arm of the study
- Multi-institutional study
- Saracatinib or placebo will be administered as a once daily, oral dose of 175 mg, for a 28-day cycle, with no breaks between cycles
- Treatment with saracatinib or placebo will be 13 cycles (364 days)
- Patients will begin Cycle 1 after complete surgical resection
- This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
- There is no charge for medical care received at NIH Clinical Center.
- PDQ (Physicians Data Query) - provides additional details about this study for health care providers.