Neoplasm Metastasis MedDRA version: 19.0 Level: LLT Classification code 10049280 Term: Solid tumour System Organ Class: 100000004864
Conditions
Interventions
Product Name: Olaratumab
Pharmaceutical Form: Concentrate and solvent for solution for injection/infusion
INN or Proposed INN: Olaratumab
CAS Number: 1024603-93-7
Other descriptive name: OLARATUMAB
Co
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
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 (=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Determine a recommended dose of olaratumab in combination with at least one of the studied chemotherapy regimens in pediatric patients based on any dose-limiting toxicities (DLTs) as well as olaratumab serum exposure-matching between the adult and pediatric populations;Primary end point(s): Number of Participants with Olaratumab Dose Limiting Toxicities (DLTs) ;Timepoint(s) of evaluation of this end point: Number of Participants with Olaratumab Dose Limiting Toxicities (DLTs), Time Frame: Cycle 1 in each arm (21 day cycle) ;Secondary Objective: Pharmacokinetics (PK): Maximum Concentration (Cmax) of Olaratumab, Time Frame: Cycle 1 in each arm (21 day cycle) Pharmacokinetics (PK): Trough Serum Concentration (Cmin) of Olaratumab, Time Frame: Cycle 1 through Cycle 5 in each arm (21 day cycles) Proportion of Participants With a Complete or Partial Response (Objective Response Rate [ORR]), Time Frame: Baseline to objective progression or start of new anti-cancer therapy (estimated up to 6 months) Progression Free Survival, Time Frame: Baseline to objective progression or death from any cause (estimated up to 6 months) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Pharmacokinetics (PK): Maximum Concentration (Cmax) of Olaratumab Pharmacokinetics (PK): Trough Serum Concentration (Cmin) of Olaratumab Proportion of Participants With a Complete or Partial Response (Objective Response Rate [ORR]), Progression Free Survival;Timepoint(s) of evaluation of this end point: Pharmacokinetics (PK): Maximum Concentration (Cmax) of Olaratumab, Time Frame: Cycle 1 in each arm (21 day cycle) Pharmacokinetics (PK): Trough Serum Concentration (Cmin) of Olaratumab, Time Frame: Cycle 1 through Cycle 5 in each arm (21 day cycles) Proportion of Participants With a Complete or Partial Response (Objective Response Rate [ORR]), Time Frame: Baseline to objective progression or start of new anti-cancer therapy (estimated up to 6 months) Progression Free Survival, Time Frame: Baseline to objective progression or death from any cause (estimated up to 6 months) | — |
Countries
United States
Contacts
Public ContactClinical Trial Registry Office
Eli Lilly and Company
Outcome results
None listed