At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 47 enrolled
Drug / intervention
Abemaciclib +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1b/2 Study of Abemaciclib in Combination With Irinotecan and Temozolomide (Part A) and Abemaciclib in Combination With Temozolomide (Part B) in Pediatric and Young Adult Patients With Relapsed/Refractory Solid Tumors and Abemaciclib in Combination With Dinutuximab, GM-CSF, Irinotecan, and Temozolomide in Pediatric and Young Adult Patients With Relapsed/Refractory Neuroblastoma (Part C)
In Brief
A Phase 2 clinical trial evaluating Abemaciclib, Irinotecan, and 3 other interventions for Relapsed Solid Tumor and Refractory Solid Tumor. Completed, enrolled 47 participants across 25 sites in 8 countries.
Detailed Summary
The study's purpose is to see if the drug, abemaciclib, is safe and effective when given with other drugs to kill cancer cells. The study is open to children and young adults with solid tumors, including neuroblastoma, that did not respond or grew during other anti-cancer treatment. For each participant, the study is estimated to last up to 2 years.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRelapsed Solid Tumor, Refractory Solid Tumor
CountriesAustralia, Belgium, France, Germany, Italy, Japan, Spain, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2020202120222023202420252026
First PostedJan 2020
Enrollment StartNov 2020
Primary CompletionMar 2024
Study CompletionAug 2025
TodayJul 2026
First PostedJan 23, 2020
Enrollment StartNov 9, 2020
Primary CompletionMar 15, 2024
Study CompletionAug 19, 2025
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 6.4 years ago
Interventions
Abemaciclibdrug
Administered orally
Irinotecandrug
Administered IV
Temozolomidedrug
Administered orally
Dinutuximabdrug
Administered IV
GM-CSFdrug
Administered SC