A Placebo-Controlled Study of Saracatinib (AZD0530) in Patients With Recurrent Osteosarcoma Local… (NCT00752206) | Clinical Trial Compass
TerminatedPhase 2
A Placebo-Controlled Study of Saracatinib (AZD0530) in Patients With Recurrent Osteosarcoma Localized to the Lung
Stopped: The Data Safety Monitoring Board (DSMB) recommended study termination for slow accrual and futility.
United States38 participantsStarted 2009-03
Plain-language 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).
Who can participate
Age range15 Years – 74 Years
SexALL
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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 th…
What they're measuring
1
Progression Free Survival Rate Among Patients Treated With Saracatinib and Placebo.
Timeframe: Evaluation for recurrence/progression will be made every 3 months for the 1st year, then every 6 months up to 2 years, then every year up to 5 years after starting treatment.
Trial details
NCT IDNCT00752206
SponsorSarcoma Alliance for Research through Collaboration