A Study of LY3295668 Erbumine in Participants With Relapsed/Refractory Neuroblastoma
- Conditions
- Neuroblastoma
- Interventions
- Registration Number
- NCT04106219
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
The reason for this study is to see if the study drug LY3295668 erbumine is safe in participants with relapsed/refractory neuroblastoma.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 71
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LY3295668 Erbumine + Topotecan + Cyclophosphamide Escalation LY3295668 Erbumine LY3295668 Erbumine given orally and topotecan and cyclophosphamide given intravenously (IV). LY3295668 Erbumine + Topotecan + Cyclophosphamide Escalation Cyclophosphamide LY3295668 Erbumine given orally and topotecan and cyclophosphamide given intravenously (IV). LY3295668 Erbumine + Topotecan + Cyclophosphamide Expansion LY3295668 Erbumine LY3295668 Erbumine given orally and topotecan and cyclophosphamide given IV. LY3295668 Erbumine Escalation LY3295668 Erbumine LY3295668 Erbumine given orally. LY3295668 Erbumine Expansion LY3295668 Erbumine LY3295668 Erbumine given orally. LY3295668 Erbumine + Topotecan + Cyclophosphamide Expansion Topotecan LY3295668 Erbumine given orally and topotecan and cyclophosphamide given IV. LY3295668 Erbumine + Topotecan + Cyclophosphamide Escalation Topotecan LY3295668 Erbumine given orally and topotecan and cyclophosphamide given intravenously (IV). LY3295668 Erbumine + Topotecan + Cyclophosphamide Expansion Cyclophosphamide LY3295668 Erbumine given orally and topotecan and cyclophosphamide given IV.
- Primary Outcome Measures
Name Time Method Duration of Response (DoR) Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (Estimated up to 5 Years) DoR
Number of Participants with Dose Limiting Toxicities (DLTs) Baseline through Cycle 2 (28 Day Cycle) Number of Participants with DLTs
Overall Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR) Baseline through Measured Progressive Disease (Estimated up to 5 Years) ORR
- Secondary Outcome Measures
Name Time Method Best Overall Response (BOR): Percentage of Participants with CR, PR, Stable Disease (SD), or Progressive Disease (PD) Baseline to Date of Objective Disease Progression (Estimated up to 5 Years) BOR
Overall Survival (OS) Baseline to Date of Death from Any Cause (Estimated up to 6 Years) OS
Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3295668 Cycle 1 Day 1 through Cycle 1 Day 15 (28 Day Cycles) PK: AUC of LY3295668
PK: AUC of LY3295668 in Combination with Topotecan and Cyclophosphamide Cycle 1 Day 1 through Cycle 1 Day 15 (28 Day Cycles) PK: AUC of LY3295668 in Combination with topotecan and cyclophosphamide
Progression-Free Survival (PFS) Baseline to Objective Progression or Death Due to Any Cause (Estimated up to 5 Years) PFS
Trial Locations
- Locations (17)
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
UZ Gent
🇧🇪Gent, Oost-Vlaanderen, Belgium
National Cancer Center Hospital
🇯🇵Chuo-ku, Tokyo, Japan
Texas Childrens Hospital
🇺🇸Houston, Texas, United States
Alder Hey Children's Hospital
🇬🇧Liverpool, United Kingdom
Universitätsklinikum Köln
🇩🇪Köln, Germany
Hospital Infantil Universitario Niño Jesús
🇪🇸Madrid, Spain
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Barcelona [Barcelona], Spain
Istituto Nazionale dei Tumori
🇮🇹Milano, Lombardie, Italy
Institut Curie
🇫🇷Paris CEDEX 05, France
Perth Children's Hospital
🇦🇺Perth, Western Australia, Australia
Children's Hospital Colorado
🇺🇸Aurora, Colorado, United States
UCSF Medical Center at Mission Bay
🇺🇸San Francisco, California, United States
University of Chicago - Comer Children's Hospital
🇺🇸Chicago, Illinois, United States
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Cincinnati Childrens Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
Centre Leon Berard
🇫🇷Lyon, Rhône-Alpes, France