A Placebo-Controlled Study of Saracatinib (AZD0530) in Patients With Recurrent Osteosarcoma Localized to the Lung
Condition: Osteosarcoma
MeSH terms: Osteosarcoma
Intervention: Saracatinib; Placebo
Intervention description: Oral Agent; Oral Agent
Intervention MeSH terms: Saracatinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 38.0
Sex: All
Minimum age: 15 Years
Maximum age: 74 Years
Healthy volunteers: No
Keywords: AZD0530; Saracatinib; Osteosarcoma; Recurrent; Localized; to the Lung

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).
    

Eligibility criteria:

        Inclusion Criteria:

          -  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.

        Exclusion Criteria:

          -  Presence of metastatic disease in other locations in addition to the lung.

          -  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.