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

Phase 1

• Conditions: eoplasm Metastasis; MedDRA version: 19.0Level: LLTClassification code 10049280Term: Solid tumourSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-005721-39-Outside-EU/EEA
• Lead Sponsor: Eli Lilly and Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06-28
• Last Update Posted: 4 July 2016

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• 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:
• Absolute neutrophil count (ANC) =750 cubic millimeters (mm³)
• Platelets =75,000/mm³
• Hemoglobin =8 grams per deciliter (g/dL)
• 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 study drug, as appropriate.
• 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

Are the trial subjects under 18? yes
Number of subjects for this age range: 70
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

• Have received treatment within 21 days of the initial dose of study drug 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified