Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Eli Lilly and Company
Age
0–17
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
The participant must have histological or cytological evidence of a diagnosis of solid tumor, excluding lymphomas and melanoma, but including central nervous system (CNS) tumors, that is relapsed or refractory, not be amenable to curative treatment.
The participant has the presence of measurable and/or nonmeasurable but evaluable disease as defined by the Response Evaluation Criteria In Solid Tumors (RECIST Version 1.1). Response Assessment in Neuro-Oncology (RANO) Criteria or Macdonald Criteria should be used for CNS tumors.
The participant has a Lansky (\<16 years of age) or Karnofsky (≥16 years of age) performance score of at least 50.
The participant has adequate hematologic, organ, and coagulation function ≤2 weeks (14 days) prior to first dose of study drug:
* Total bilirubin (sum of conjugated + unconjugated) ≤1.5 x upper limit of normal (ULN) for age
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0 x ULN
* Serum creatinine is based on age/gender
* Adequate coagulation function as defined by International Normalized Ratio ≤1.5 or prothrombin time ≤1.5 x ULN, and partial thromboplastin time ≤1.5 x ULN
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 olaratumab, or longer for other study drugs according to their label.
Participants must have fully recovered from the acute toxic effects of all prior anticancer therapies or must adhere to post-treatment conditions as follows:
* Myelosuppressive chemotherapy
* Hematopoietic growth factors
* Biologic (anti-neoplastic agent)
* Antibody therapy
* Radiation
* Stem cell infusion without traumatic brain injury
* Corticosteroids
You may not be if
Have received treatment within 21 days of the initial dose of olaratumab with an investigational product or non-approved use of a drug or device or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
Participants that have had bone marrow or solid organ transplant are excluded.
The participant has an active fungal, bacterial, and/or known severe viral infection including human immunodeficiency virus (HIV) or viral (A, B, or C) hepatitis (screening is not required).
Female participants who are pregnant or breastfeeding are excluded.
If the participant is to be enrolled in the doxorubicin combination arm, a left ventricular dysfunction (LVEF \< 50%) or shortening fraction of \<27% by echocardiogram (either multigated acquisition \[MUGA\] or echocardiogram \[ECHO\] are required, not both).
Participants that have received prior anthracycline therapy if the participant is to be enrolled in the doxorubicin combination arm.
