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

Phase 1Active Not RecruitingNCT04106219

Eli Lilly and Company71 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Neuroblastoma

Interventions

LY3295668 ErbumineDRUG

Administered orally.

TopotecanDRUG

Administered IV.

CyclophosphamideDRUG

Administered IV.

Eligibility

Sex: ALLMin age: 2 YearsMax age: 21 Years

Medical Language ↔ Plain English

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.

Locations (17)

UCSF Medical Center at Mission Bay

San Francisco, California, United States

Children's Hospital Colorado

Aurora, Colorado, United States

Outcomes

Primary Outcomes

Number of Participants with Dose Limiting Toxicities (DLTs)

Number of Participants with DLTs

Time frame: Baseline through Cycle 2 (28 Day Cycle)

Overall Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR)

ORR

Time frame: Baseline through Measured Progressive Disease (Estimated up to 5 Years)

Duration of Response (DoR)

DoR

Time frame: Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (Estimated up to 5 Years)

Secondary Outcomes

Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3295668

PK: AUC of LY3295668

Time frame: Cycle 1 Day 1 through Cycle 1 Day 15 (28 Day Cycles)

PK: AUC of LY3295668 in Combination with Topotecan and Cyclophosphamide

PK: AUC of LY3295668 in Combination with topotecan and cyclophosphamide

Time frame: Cycle 1 Day 1 through Cycle 1 Day 15 (28 Day Cycles)

Best Overall Response (BOR): Percentage of Participants with CR, PR, Stable Disease (SD), or Progressive Disease (PD)

BOR

Time frame: Baseline to Date of Objective Disease Progression (Estimated up to 5 Years)

Progression-Free Survival (PFS)

PFS

Time frame: Baseline to Objective Progression or Death Due to Any Cause (Estimated up to 5 Years)

Data from ClinicalTrials.gov

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