Osteosarcoma Clinical Trial
Official title:
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
Verified date | April 2019 |
Source | Sarcoma Alliance for Research through Collaboration |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Terminated |
Enrollment | 38 |
Est. completion date | December 2017 |
Est. primary completion date | August 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 15 Years to 74 Years |
Eligibility |
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 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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan | Ann Arbor | Michigan |
United States | Johns Hopkins Sidney Kimmel Comprehensive Cancer Center | Baltimore | Maryland |
United States | National Cancer Institute | Bethesda | Maryland |
United States | University of Alabama | Birmingham | Alabama |
United States | Dana-Farber Cancer Institute | Boston | Massachusetts |
United States | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio |
United States | University of Florida | Gainesville | Florida |
United States | Indiana University | Indianapolis | Indiana |
United States | University of Iowa Hospitals and Clinics | Iowa City | Iowa |
United States | Children's Hospital Los Angeles | Los Angeles | California |
United States | UCLA/Mattel's Children's Hospital | Los Angeles | California |
United States | USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles | California |
United States | St. Jude Children's Research Hospital | Memphis | Tennessee |
United States | University of Miami | Miami | Florida |
United States | Stanford University | Palo Alto | California |
United States | UCSF | San Francisco | California |
United States | Sarcoma Oncology Center | Santa Monica | California |
United States | Seattle Cancer Care Alliance/University of Washington Medical Center | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
Sarcoma Alliance for Research through Collaboration | AstraZeneca |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression Free Survival Rate Among Patients Treated With Saracatinib and Placebo. | To determine if the addition of saracatinib to pulmonary metastasectomy, versus placebo and pulmonary metastasectomy, results in a change in progression free survival. | 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. | |
Secondary | Change in Overall Survival With the Addition of Saracatinib to Pulmonary Metastasectomy, Versus Placebo and Pulmonary Metastasectomy | To determine if the addition of saracatinib to pulmonary metastasectomy, versus placebo and pulmonary metastasectomy, results in a change in overall survival. | 5 year overall survival | |
Secondary | Change in Time to Treatment Failure With the Addition of Saracatinib to Pulmonary Metastasectomy, Versus Placebo and Pulmonary Metastasectomy | To determine if the addition of saracatinib to pulmonary metastasectomy, versus placebo and pulmonary metastasectomy, results in a change in the time to treatment failure. Time to treatment failure is the time from randomization to treatment discontinuation. | Up to 12 months | |
Secondary | Number of Genes Identified for Prediction of Recurrence of Osteosarcoma | To perform microarray analysis of tumor samples to identify a gene signature that predicts for recurrence of osteosarcoma using methodology that relies on preparation of RNA, followed by cDNA. Fluorescent labeling followed by hybridization to a DNA chip allows for quantitative scanning for hybridized complexes. | Up to 12 months | |
Secondary | Biomarkers Related to Activation of Src and Src Substrates | To evaluate tumor samples for biomarkers related to activation of Src and Src substrates. | Up to 12 months | |
Secondary | Cell Lines and Murine Xenografts From Recurrent Tumor Samples | To establish cell lines and murine xenografts from recurrent tumor samples. | Up to 12 months | |
Secondary | Number of Mutations Identified That May be Causative For Recurrent Osteosarcoma | To perform sequencing analysis of DNA and RNA in tumor samples compared to normal blood to detect mutations that may be causative for recurrent osteosarcoma. The methodology uses transcriptome sequencing, exon re-sequencing and mate-pair end sequencing, allowing us to detect translocations. The availability of matched normal DNA in the blood will allow us to determine which changes are unique to the tumor. | Up to 12 months |
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