At a glance
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A Phase 1, Open-Label, Dose-Escalation Study of Olaratumab as a Single Agent and in Combination With Doxorubicin, Vincristine/Irinotecan, or High-Dose Ifosfamide in Pediatric Patients With Relapsed or Refractory Solid Tumors
In Brief
A Phase 1 clinical trial evaluating Olaratumab, Doxorubicin, and 3 other interventions for Neoplasm Metastasis. Completed, enrolled 68 participants across 21 sites in 2 countries.
Detailed Summary
The main purpose of this study is to evaluate the safety of different doses of olaratumab and to determine which dose should be used for future pediatric studies. The present study is open to children with advanced cancer or cancer that has spread to another part of the body. The study has three parts. In the first two parts, a specific dose of olaratumab will be given in 21 day cycles, followed by one of three standard chemotherapy regimens. In the third part, a specific dose of olaratumab will be given with one of three standard chemotherapy regimens in 21 day cycles. Participants will only enroll in one part.
Study Details
Timeline
Interventions
Olaratumab administered IV.
Doxorubicin administered IV.
Vincristine administered IV.
Irinotecan administered IV.
Ifosfamide administered IV.