(2R,4R)-1-(3-CHLORO-2-FLUOROBENZYL)-4-((3-FLUORO-6-((5-METHYL-1H-PYRAZOL-3-YL)AMINO)PYRIDIN-2-YL)METHYL)-2-METHYLPIPERIDINE-4-CARBOXYLIC ACID for Neuroblastoma

Inclusion criteria

• {"criterion_text":"- 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.\n- Participants must be able to swallow capsules."}

Exclusion criteria

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

Primary endpoints

• {"endpoint_text":"- dose-limiting toxicity","definition_or_measurement_approach":""}
• {"endpoint_text":"- safety, including, but not limited to TEAEs (treatment-emergent adverse events), SAEs (serious adverse events), deaths, and clinical laboratory","definition_or_measurement_approach":"Safety assessed by occurrence of TEAEs, SAEs, deaths, and clinical laboratory abnormalities as recorded during the study."}
• {"endpoint_text":"- abnormalities per CTCAE (Common Terminology Criteria for Adverse Events) (Version 5.0)","definition_or_measurement_approach":"Adverse event severity graded using CTCAE Version 5.0."}
• {"endpoint_text":"- overall response rate","definition_or_measurement_approach":""}
• {"endpoint_text":"- overall Survival","definition_or_measurement_approach":""}

Spain

Earliest CTIS Part Ii Submission Date

30-07-2024

Latest Decision Or Authorization Date

02-10-2024

Processing Time Days

64

Number Of Sites

2

Number Of Participants

1

Primary sponsor

Full Name

Eli Lilly & Co.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

IQVIA RDS Spain S.L.

Responsibilities

sponsorDuties codes: 1, 5

Third parties

• {"country":"Spain","full_name":"IQVIA RDS Spain S.L.","duties_or_roles":"sponsorDuties codes: 1, 5","organisation_type":"Pharmaceutical company"}