Status:
TERMINATED
A Placebo-Controlled Study of Saracatinib (AZD0530) in Patients With Recurrent Osteosarcoma Localized to the Lung
Lead Sponsor:
Sarcoma Alliance for Research through Collaboration
Collaborating Sponsors:
AstraZeneca
Conditions:
Osteosarcoma
Eligibility:
All Genders
15-74 years
Phase:
PHASE2
Brief 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 ...
Detailed Description
Further details provided by SARC (Sarcoma Alliance for Research through Collaboration): After complete surgical removal of their cancer, patients will be randomly assigned to receive either Saracatin...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00752206
Start Date
March 1 2009
End Date
December 1 2017
Last Update
January 18 2020
Active Locations (18)
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1
University of Alabama
Birmingham, Alabama, United States, 35233
2
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
3
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90089
4
UCLA/Mattel's Children's Hospital
Los Angeles, California, United States, 90095