Abstract
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
Journal of clinical oncology, Vol.31(15_suppl), pp.TPS10591-TPS10591
05/20/2013
DOI: 10.1200/jco.2013.31.15_suppl.tps10591
Abstract
TPS10591
Background: Osteosarcoma is a rare cancer and 33% of patients who have completed primary treatment will recur. The Src pathway has been implicated in the metastatic behavior of several tumors including osteosarcoma where 95% of samples express Src or have evidence of downstream activation of this pathway. Saracatinib (AZD0530) is a potent and selective Src kinase inhibitor. The recommended phase II dose in adults was found to be 175mg daily. The primary goal of this study is to determine if treatment with Saracatinib can increase progression free survival (PFS) for patients who have undergone complete resection of metastatic osteosarcoma nodules in the lung. Secondary goals are evaluation of overall survival, time to treatment failure, and evaluation of several biological correlatives. Methods: This is a multi-institutional, phase II.5, placebo-controlled study with an accrual goals of 88 randomized patients. Patients between 15 and 75 years, with histological confirmation of recurrent osteosarcoma, localized to the lung, who have potential for complete surgical resection, are eligible for enrollment. After complete resection, patients are randomized to treatment with saracatinib or placebo, of a daily oral dose of 175 mg, continuously for up to 1 year or until progression. Patients who recur in the lung while on-study and who are amenable to complete surgical resection will be un-blinded. Those patients who received placebo may have the option to undergo surgical resection. If fully resected, they will be offered therapy with saracatinib under the same treatment guidelines as above. As of January 2013, 38 patients have enrolled and 32 patients met the criteria to be randomized and began oral therapy with either saracatinib or placebo. An interim analysis is planned after 40 patients have been randomized. Clinical trial information: NCT00752206.
Details
- Title: Subtitle
- 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
- Creators
- Kristin Baird - National Cancer InstituteDenise K. Reinke - Sarcoma Alliance for Research through CollaborationJoseph Gerald Pressey - University of Alabama at BirminghamLeo Mascarenhas - Children's Hospital of Los AngelesNoah Federman - University of California, Los AngelesNeyssa Marina - Stanford UniversitySant P. Chawla - Sarcoma Oncology CenterJoanne Pigues Lagmay - Nationwide Children's HospitalJohn M. Goldberg - University of MiamiMohammed M. Milhem - University of IowaDavid Mark Loeb - Johns Hopkins UniversityJames E. Butrynski - Dana-Farber Cancer InstituteKatherine A. Janeway - Dana-Farber Cancer InstituteBrian Turpin - Cincinnati Children's Hospital Medical CenterArthur P. Staddon - University of PennsylvaniaSheri L. Spunt - St. Jude Children's Research HospitalEve T. Rodler - Seattle Cancer Care AllianceScott Schuetze - University of Michigan–Ann ArborScott H. Okuno - Mayo ClinicLee J. Helman - Center for Cancer Research, National Cancer Institute, Bethesda, MD
- Resource Type
- Abstract
- Publication Details
- Journal of clinical oncology, Vol.31(15_suppl), pp.TPS10591-TPS10591
- DOI
- 10.1200/jco.2013.31.15_suppl.tps10591
- ISSN
- 0732-183X
- eISSN
- 1527-7755
- Language
- English
- Date published
- 05/20/2013
- Academic Unit
- Hematology, Oncology, and Blood & Marrow Transplantation; Internal Medicine
- Record Identifier
- 9984363185402771
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