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Sarcoma

AZD0530 for Recurrent Osteosarcoma Localized to the Lung (7008)
A Randomized, Double-Blinded, Placebo-Controlled, Multi-Institutional, Phase II.5 Study of AZD0530, a Selective Src Kinase Inhibitor, In Patients with Recurrent Osteosarcoma Localized to the Lung
Status Conditions Phase Study ID
Recruiting Osteosarcoma Phase II 7008
NCT00923286
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).

 

Investigator
Robin L. Jones, MD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)
Ages Eligible for Study:   15 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
Last Updated
August 20, 2012
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.