A Phase 1 Study of LY3295668 Erbumine Monotherapy and in Combination in Patients with Relapsed/Refractory Neuroblastoma

Phase 1

• Conditions: Relapsed/Refractory Neuroblastoma; MedDRA version: 20.0Level: PTClassification code 10029260Term: NeuroblastomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2019-001042-18-GB
• Lead Sponsor: Eli Lilly and Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-11-11
• Last Update Posted: 3 August 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 71

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

- 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

Study & Design

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