A Study of LY3295668 Erbumine in Participants With Relapsed/Refractory Neuroblastoma

Lilly

Status and phase: Active, not recruiting; Phase 1

Conditions: Neuroblastoma

Treatments: Drug: Topotecan; Drug: Cyclophosphamide; Drug: LY3295668 Erbumine

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT04106219

17295

2019-01

J1O-MC-JZHD (Other Identifier)

ITCC-085 (Other Identifier)

2019-001042-18 (EudraCT Number)

Details and patient eligibility

About

The reason for this study is to see if the study drug LY3295668 erbumine is safe in participants with relapsed/refractory neuroblastoma.

Enrollment: 71 estimated patients

Sex: All

Ages: 2 to 21 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants must have relapsed/refractory neuroblastoma and have active disease in at least one site: bone, bone marrow or soft tissue. Participants must be able to submit an archival sample of tissue.
• Participants must be able to swallow capsules.

Exclusion criteria

• Participants must not have had an allogeneic hematopoietic stem cell, bone marrow, or solid organ transplant.
• Participants must not have untreated tumor that has spread to the brain or spinal cord.
• Participants must not have a serious active disease other than neuroblastoma.
• Participants must not have a condition affecting absorption.
• Participants must not have had prior aurora kinase inhibitor exposure.
• Participants must not have a known allergy to the study treatment.
• Participants must not have symptomatic human immunodeficiency virus (HIV) infection or symptomatic activated/reactivated hepatitis A, B, or C.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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71 participants in 4 patient groups

LY3295668 Erbumine Escalation

Experimental group

Description:

LY3295668 Erbumine given orally.

Treatment:

Drug: LY3295668 Erbumine

LY3295668 Erbumine + Topotecan + Cyclophosphamide Escalation

Experimental group

Description:

LY3295668 Erbumine given orally and topotecan and cyclophosphamide given intravenously (IV).

Treatment:

Drug: LY3295668 Erbumine

Drug: Cyclophosphamide

Drug: Topotecan

LY3295668 Erbumine Expansion

Experimental group

Description:

LY3295668 Erbumine given orally.

Treatment:

Drug: LY3295668 Erbumine

LY3295668 Erbumine + Topotecan + Cyclophosphamide Expansion

Experimental group

Description:

LY3295668 Erbumine given orally and topotecan and cyclophosphamide given IV.

Treatment:

Drug: LY3295668 Erbumine

Drug: Cyclophosphamide

Drug: Topotecan