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Complete title: 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
|Research Study Number||7008|
|Principal Investigator||Robin Jones|
Research Study Description
Eligibility Criteria (must meet the following to participate in this study)
Genders Eligible for Study: Both
- 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.
Other eligibility criteria may apply.
Exclusions (conditions that would prevent participation in this study)
- Disruption of the lung pleura by tumor.
- Paget's disease.
- Patient currently using, or has previously used CYP3A4 inducers or inhibitors within 2 to 14 days prior to the initiation of oral therapy.
- Known hypersensitivity to other Src/Abl non-receptor kinase inhibitors.
- Evidence of interstitial lung disease.
- Any concurrent condition which in the investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the protocol.
- Myocardial infarction within one year prior to study entry.
- Bleeding diathesis, resulting in symptomatic bleeding.
- Patient is pregnant or nursing/breast-feeding.
- Patient received chemotherapy, biological or investigational agent = 28 days prior to enrollment.
- Patient experiencing unresolved toxicity = CTCAE grade 2 (except alopecia) from previous agents.
Other exclusion criteria may apply.
Bone Cancer; Sarcoma; Solid Tumors
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