A Randomized, Double-Blinded, Placebo-Controlled, Multi-Institutional, Cross-over, Phase II.5 Study of Saracatinib (AZD0530), a Selective Src Kinase Inhibitor, In Patients With Recurrent Osteosarcoma Localized to the Lung
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).
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- drug : Saracatinib
- drug : Placebo
Phase: Phase 2
Ages Eligible For Study:
- Patient had recurrence of osteosarcoma, localized to the lungs, had complete surgical removal of all lung nodules are eligible for enrollment. - Patient with suspected recurrence of osteosarcoma but who has not had surgery is eligible for enrollment but will not be randomized to receive study medication until deemed fully eligible following surgical removal of all lung nodules. - Patient had histological confirmed diagnosis of osteosarcoma of the recurrent sample. - Patient had recurrence of osteosarcoma in the lung following standard therapy including: adriamycin, cisplatin, ifosfamide and methotrexate. - Patient is ? 15 and < 75 years of age. - Weight ? 34 kg. - ECOG performance score of 0-2. - Adequate bone marrow function. - Adequate renal function. - Adequate hepatic function. - Adequate cardiac function. - Women of childbearing potential must have had a negative pregnancy test (urine or serum) ? 7 days prior to enrollment, and willingness to use an acceptable method of contraception during participation in the study and for 3 months after the last dose. - Randomization must occur ? 6 weeks after complete surgical resection. - Patient or legal guardian has signed informed consent.