1. Phase 1 trial of olaratumab monotherapy and in combination with chemotherapy in pediatric patients with relapsed/refractory solid and central nervous system tumors
- Author
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Leo Mascarenhas, Chitose Ogawa, Theodore W. Laetsch, Brenda J. Weigel, Michael W. Bishop, Julie Krystal, Scott C. Borinstein, Emily K. Slotkin, Jodi A. Muscal, Pooja Hingorani, Donna E. Levy, Gary Mo, Ashwin Shahir, Jennifer Wright, and Steven G. DuBois
- Subjects
chemotherapy ,olaratumab ,pediatric cancer ,platelet‐derived growth factor receptor ,Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,RC254-282 - Abstract
Abstract Olaratumab is a monoclonal antibody that specifically binds to platelet‐derived growth factor receptor alpha (PDGFRα) and blocks receptor activation. We conducted a phase 1 trial to evaluate the safety of olaratumab and determine a recommended dose in combination with three different chemotherapy regimens in children. Patients 25% of patients included neutropenia, anemia, leukopenia, lymphopenia, and thrombocytopenia. Pharmacokinetic profiles of olaratumab with chemotherapy were within the projected range based on adult data. There was one complete response (rhabdomyosarcoma [Part B vincristine/irinotecan arm]) and three partial responses (two rhabdomyosarcoma [Part A doxorubicin arm and Part C doxorubicin arm]; one pineoblastoma [Part B vincristine/irinotecan arm]). Olaratumab was tolerable and safely administered in combination with chemotherapy regimens commonly used in children and adolescents.
- Published
- 2021
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