A Placebo-Controlled Study of Saracatinib (AZD0530) in Patients With Recurrent Osteosarcoma Localized to the Lung
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).
Checked against the public recordLast updated Jan 18, 2020 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Sarcoma Alliance for Research through Collaboration
- Interventions being studied
- Drug: Saracatinib; Drug: Placebo
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- University of AlabamaBirmingham, Alabama
- Children's Hospital Los AngelesLos Angeles, California
- USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California
- UCLA/Mattel's Children's HospitalLos Angeles, California
- Stanford UniversityPalo Alto, California
- UCSFSan Francisco, California
- Sarcoma Oncology CenterSanta Monica, California
- University of FloridaGainesville, Florida
- University of MiamiMiami, Florida
- Indiana UniversityIndianapolis, Indiana
- University of Iowa Hospitals and ClinicsIowa City, Iowa
- Johns Hopkins Sidney Kimmel Comprehensive Cancer CenterBaltimore, Maryland
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jan 18, 2020. Always confirm current availability with the study team.