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| Diagnosis | Solid Tumor | Study Status | Suspended |
| Phase | I/II |
| Age | up to 21 Years | Randomisation | NO |
| Line of treatment | Disease relapse or progression |
| Routes of Treatment Administration | Abemaciclib (Given Orally) in combination with:
Irinotecan and Temozolomide (Part A Only)
Temozolomide alone (Part B Only)
Dinutuximab, GM-CSF, Irinotecan, and Temozolomide (Part C Only) |
| Last Posted Update | 2024-05-02 |
| ClinicalTrials.gov # | NCT04238819 |
International Sponsor
Eli Lilly and CompanyPrincipal Investigators for Canadian Sites
Ste Justine - Dr. Pierre Teira
Centres
Medical contact
Dr. Henrique Bittencourt
Dr. Monia Marzouki
Dr. Sebastien Perreault (neuro-onc)
Social worker/patient navigator contact
Marie-Claude Charrette
Clinical research contact
Marie Saint-Jacques
Study Description
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.
Inclusion Criteria
- Participants must be ≤ 18 years of age (Part A and B only) or < 21 years of age (Part C only)
- Must have adequate body surface area (BSA)
- Participants must have a solid tumour (excluding lymphoma) that has come back or progressed on standard therapies
- PART C ONLY: Participants with neuroblastoma that has come back or progressed on standard therapies
- Participants must be able to be up and about for at least half of their waking hours
- Participants of reproductive potential must not be pregnant within 7 days of and during the study
- Ability to swallow
- Participants and their families (as applicable) must agree to the study assessments by signing an informed consent form
Other inclusion and exclusion criteria may apply and will be discussed with you by the study team
