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

2024-512102-25-00 Protocol JIO-MC-JZHD Human pharmacology (Phase I) - Other Ongoing, recruitment ended

Start 29 Jul 2020 · Status Ongoing, recruitment ended · 1 EU/EEA countries · 2 sites · Protocol JIO-MC-JZHD

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - Other
Status Ongoing, recruitment ended
Participants planned 1
Countries 1
Sites 2

Neuroblastoma

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

Key facts

Sponsor
Eli Lilly & Co.
Participant type
Pediatric, Patients
Age range
0-17 years, 18-64 years
Gender
Male and Female
Therapeutic area
Diseases [C] - Neoplasms [C04]
Trial duration
29 Jul 2020 → ongoing
Decision date (initial)
2024-08-13
Transition trial
Yes
Low-intervention
No
Rare-disease indication
Yes
Vulnerable population
Yes

External identifiers

EU CT number
2024-512102-25-00
EudraCT number
2019-001042-18
WHO UTN
U1111-1308-9086
ClinicalTrials.gov
NCT04106219

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Safety, Pharmacogenetic, Efficacy, Others, Pharmacogenomic, Therapy

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

Conditions and MedDRA coding

Neuroblastoma

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 2

  1. 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.
  2. Participants must be able to swallow capsules.

Exclusion criteria 7

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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 5

  1. dose-limiting toxicity
  2. safety, including, but not limited to TEAEs (treatment-emergent adverse events), SAEs (serious adverse events), deaths, and clinical laboratory
  3. abnormalities per CTCAE (Common Terminology Criteria for Adverse Events) (Version 5.0)
  4. overall response rate
  5. overall Survival

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

(2R4R-1-3-CHLORO-2-FLUOROBENZYL-4-3-FLUORO-6-5-METHYL-1H-PYRAZOL-3-YLAMINOPYRIDIN-2-YLMETHYL-2-METHYLPIPERIDINE-4-CARBOXYLIC Acid

PRD7637246 · Product

Active substance
(2R4R-1-3-CHLORO-2-FLUOROBENZYL-4-3-FLUORO-6-5-METHYL-1H-PYRAZOL-3-YLAMINOPYRIDIN-2-YLMETHYL-2-METHYLPIPERIDINE-4-CARBOXYLIC Acid
Pharmaceutical form
CAPSULE
Route of administration
ORAL USE
Authorisation status
Not Authorised
MA holder
ELI LILLY AND COMPANY
Paediatric formulation
No
Orphan designation
No

(2R4R-1-3-CHLORO-2-FLUOROBENZYL-4-3-FLUORO-6-5-METHYL-1H-PYRAZOL-3-YLAMINOPYRIDIN-2-YLMETHYL-2-METHYLPIPERIDINE-4-CARBOXYLIC Acid

PRD7637245 · Product

Active substance
(2R4R-1-3-CHLORO-2-FLUOROBENZYL-4-3-FLUORO-6-5-METHYL-1H-PYRAZOL-3-YLAMINOPYRIDIN-2-YLMETHYL-2-METHYLPIPERIDINE-4-CARBOXYLIC Acid
Pharmaceutical form
CAPSULE
Route of administration
ORAL USE
Authorisation status
Not Authorised
MA holder
ELI LILLY AND COMPANY
Paediatric formulation
No
Orphan designation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Eli Lilly & Co.

137 Total trials 45 Recruiting 84 Ended
Commercial
Sponsor organisation
Eli Lilly & Co.
Address
1 Lilly Corporate Center
City
Indianapolis
Postcode
46285-0001
Country
United States

Scientific contact point

Organisation
Eli Lilly & Co.
Contact name
Lilly Clinical Trials information desk

Public contact point

Organisation
Eli Lilly & Co.
Contact name
Lilly Clinical Trials information desk

Third parties 1

OrganisationCity, countryDuties
IQVIA RDS Spain S.L.
ORG-100014508
 Madrid, Spain On site monitoring, Code 5

Locations

1 EU/EEA country · 2 investigational sites

By country

CountryMS statusPlanned subjectsSites
Spain Ongoing, recruitment ended 1 2
Rest of world — 0 —

Investigational sites

Spain

2 sites · Ongoing, recruitment ended
Hospital Universitari Vall D Hebron
Servei de Hematologia i Oncologia Pediatrica, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitari Vall D Hebron
Servei de Hematologia i Oncologia Pediatrica, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Spain 2020-07-29 2020-09-10 2021-11-04

Application history

2 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-08-06 Spain Acceptable with conditions
2024-08-13
 2024-08-13
2 SUBSTANTIAL MODIFICATION SM-1 2024-09-10 Spain Acceptable with conditions 2024-10-02

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