Study Condition(s): Pediatric Neoplasm Metastasis

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

Study Alias: JGDN

Study Identifier(s): Tool Tip Icon {{ defaultRegistry.registryAnchorText }} NCT02677116 {{ currentLocaleObject.registryAnchorText }}

Study Purpose

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 two parts. In each part, a specific dose of olaratumab will be given alone for 21 days and followed by one of three standard chemotherapy regimens. Participants will enroll in one part only.

Key Participation Requirements Tool Tip Icon

All clinical trials have rules about who can participate. This section outlines some of those rules. Please contact a study center to discuss the full set of criteria

Gender

Male Female

Age

≤17 years

Time Commitment

Your participation could last up to 3 years depending on how you and your tumor respond.
  • Participant must have a diagnosis of solid tumor, excluding lymphomas and melanoma, but including central nervous system (CNS) tumors that is confirmed by histology or cytology

  • Female participant must not be pregnant or breastfeeding and both female and male participants of child-bearing potential must agree to use highly effective contraceptive precautions during the trial and up to 3 months following the last dose of study drug

  • Participant must not have had bone marrow or solid organ transplant

  • Participant must not have an active fungal, bacterial, and/or known severe viral infection including human immunodeficiency virus (HIV) or viral (A, B, or C) hepatitis

Where to Participate

20 locations are currently available of 20 planned
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