NCT02677116

A Study of Olaratumab Alone and in Combination With Standard Chemotherapies in Children With Cancer

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neoplasm Metastasis

Interventions

Type	Name	Description
DRUG	Olaratumab	Olaratumab administered IV.
DRUG	Doxorubicin	Doxorubicin administered IV.
DRUG	Vincristine	Vincristine administered IV.
DRUG	Irinotecan	Irinotecan administered IV.
DRUG	Ifosfamide	Ifosfamide administered IV.

Timeline

• Start date: 2016-08-29
• Primary completion: 2018-10-10
• Completion: 2019-04-03
• First posted: 2016-02-09
• Last updated: 2020-05-20
• Results posted: 2020-05-20

Locations

21 sites across 2 countries: United States, Japan