Relapsed/Refractory Neuroblastoma MedDRA version: 20.0 Level: PT Classification code 10029260 Term: Neuroblastoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Code: LY3295668
Pharmaceutical Form: Capsule
INN or Proposed INN: LY3295668
Other descriptive name: LY3295668
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - having a refractory/recurrent neuroblastoma - patient must be between 2-21 years old - must have demonstrated active disease - providing a mandatory archival sample of tissue - being able to swallow capsules Are the trial subjects under 18? yes Number of subjects for this age range: 70 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - having untreated central nervous system metastases - serious concomitant disorder: e.g. active infection, GI disorder, profound immune suppression - malabsorption - serious heart condition: congestive heart failure, arrhythmias, valvulopathy - body surface area (BSA) < 0.5 square meter - pregnant or breastfeeding - have symptomatic human immunodeficiency virus (HIV) infection or symptomatic activated/reactivated hepatitis A, B, or C
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Because this is a dose-finding study, data will be reviewed on a patient-by-patient basis during the study until the RP2Ds are determined for each treatment regimen. Interim analyses for monotherapy and combination therapy will occur after all patients in each first stage have had the opportunity to receive 4 cycles of treatment and 2 postbaseline response assessments. The interim analysis based on safety and early signs of efficacy will be conducted if the total number of patients with DLT equivalent toxicities at the RP2D in both Part I and Part II has reached boundaries calculated based on the posterior probability that the true DLT equivalent rate is = 25% with a probability of =70%;Main Objective: Determination of recommended Phase 2 dose of LY3295668 alone and in combination through safety and tolerability analysis Evaluation of the activity of Ly3295668 on tumors of patient with recurrent/ refractory neuroblastoma ;Secondary Objective: To determine pharmacokinetics of Ly3295668 alone and in combination To investigate if LY3295668 exposition is associated with response in terms of efficacy;Primary end point(s): - dose-limiting toxicity -safety, including, but not limited to TEAEs (treatment-emergent adverse events), SAEs (serious adverse events), deaths, and clinical laboratory abnormalities per CTCAE (Common Terminology Criteria for Adverse Events) (Version 5.0) - overall response rate - overall Survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Plasma concentrations of LY3295668 - BOR (best overall response), PFS (progression-free survival) , OS (overall survival);Timepoint(s) of evaluation of this end point: Efficacy will be assessed both at the conclusion of Part I-A, I-B, and during interim analysis of Part II. | — |
Countries
Belgium, Canada, France, Germany, Italy, Japan, Spain, United Kingdom, United States
Contacts
Public ContactClinical Trial Registry Office
Eli Lilly and Company
Outcome results
None listed