A Randomized, Double-Blinded, Placebo-Controlled, Multi-Institutional, Cross-over, Phase II.5 Study of Saracatinib (AZD0530), a Selective Src Kinase Inhibitor, In Patients With Recurrent Osteosarcoma Localized to the Lung
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 Saracatinib or placebo (a sugar pill) throughout the study. Patients will
take Saracatinib (or placebo) once daily by mouth for a total of 364 days. The duration of
treatment is divided into 13 cycles, 28 days each cycle with no breaks in between.
Patients will be seen for interim medical history, physical exam and laboratory studies
prior to each cycle. To monitor for recurrence of tumor, patients will undergo thoracic CT
scans at 3-4 weeks, 6-8 weeks, at 3 months, at 6 months, at 9 months, at 12 months, then
every 6 months up to 2 years, and then every year up to 5 years after starting treatment.
An electrocardiogram (ECG) will be taken at 3 months, and a bone scan will be performed at
Patients who recur in the lung while on-study and who are thought to be amenable to complete
surgical resection will be able to find out if they were receiving placebo or saracatinib.
Those patients who were receiving placebo may then have the option of undergoing surgical
resection. If fully resected of all recurrent disease,they will be given the option of
receiving oral therapy with saracatinib. Saracatinib will be administered as a once daily,
oral dose of 175 mg, for a 28-day cycle, with no breaks between cycles. The duration of
treatment with saracatinib will be thirteen 28-day cycles (364 days total). If complete
resection of all lung nodules is not achieved, the patient will be removed from the study.
Patients who recur in locations other than the lung while on-study will be taken off study
at that time.
Blood and tumor samples for research purposes will be collected at the time the tumor is
After completing all 13 cycles, patients will be followed for approximately every 3 months
until 2 years from starting treatment, then approximately every 6 months until 4 years from
starting treatment, and once at year 5.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
To determine the progression free survival rate among patients treated with Saracatinib and placebo.
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.
Kristin Baird, MD
National Cancer Institute - Pediatric Oncology Branch
United States: Food and Drug Administration
|University of Alabama||Birmingham, Alabama|
|University of Michigan||Ann Arbor, Michigan 48109-0624|
|UCSF||San Francisco, California 941430324|
|University of Iowa Hospitals and Clinics||Iowa City, Iowa 52242|
|University of Pittsburgh Cancer Institute||Pittsburgh, Pennsylvania 15213|
|Stanford University||Stanford, California 94305|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|USC/Norris Comprehensive Cancer Center and Hospital||Los Angeles, California 90033-0804|
|Children's Hospital Los Angeles||Los Angeles, California 90027-0700|
|St. Jude Children's Research Hospital||Memphis, Tennessee 38105-2794|
|Cincinnati Children's Hospital Medical Center||Cincinnati, Ohio 45229-3039|
|University of Florida||Gainesville, Florida 32610-0277|
|University of Miami||Miami, Florida 33136|
|Indiana University||Indianapolis, Indiana 46202|
|Johns Hopkins Sidney Kimmel Comprehensive Cancer Center||Baltimore, Maryland 21231|
|Sarcoma Oncology Center||Santa Monica, California 90403|
|National Cancer Institute||Bethesda, Maryland 20892-1922|
|UCLA/Mattel's Children's Hospital||Los Angeles, California 90095|
|Pennsylvania Hematology Oncology Associates||Philadelphia, Pennsylvania 19106|
|Seattle Cancer Care Alliance/University of Washington Medical Center||Seattle, Washington 98109|