A Placebo-Controlled Study of Saracatinib (AZD0530) in Patients With Recurrent Osteosarcoma Localized to the Lung

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Osteosarcoma

In brief

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).

Key facts

Study ID

NCT00752206

Run by

Sarcoma Alliance for Research through Collaboration

People needed

38

Starts

2009-03-01

Expected to finish

2017-12-01

Last updated by the study team

2020-01-18

Who can join

Age: 15 and older, up to 74. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Alabama — Birmingham, Alabama, United States
• Children's Hospital Los Angeles — Los Angeles, California, United States
• USC/Norris Comprehensive Cancer Center and Hospital — Los Angeles, California, United States
• UCLA/Mattel's Children's Hospital — Los Angeles, California, United States
• Stanford University — Palo Alto, California, United States
• UCSF — San Francisco, California, United States
• Sarcoma Oncology Center — Santa Monica, California, United States
• University of Florida — Gainesville, Florida, United States
• University of Miami — Miami, Florida, United States
• Indiana University — Indianapolis, Indiana, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• Johns Hopkins Sidney Kimmel Comprehensive Cancer Center — Baltimore, Maryland, United States
• National Cancer Institute — Bethesda, Maryland, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• St. Jude Children's Research Hospital — Memphis, Tennessee, United States
• Seattle Cancer Care Alliance/University of Washington Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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