Abemaciclib Combination Therapy for Neuroblastoma

Recruiting at 62 trial locations

Overseen By There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Age: < 65

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Eli Lilly and Company

Must not be taking: CYP3A inhibitors, UGT1A1 inhibitors

Disqualifiers: Transplant, Pregnancy, Infections, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

117 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Eligibility Criteria

This trial is for children and young adults up to age 21 with solid tumors, including neuroblastoma, that haven't improved after treatment. They must be able to swallow pills, have a body weight over 10 kg, not be pregnant or breastfeeding, and agree to use contraception. Those with certain other health conditions or treatments are excluded.

Inclusion Criteria

I and my caregiver can commit to the full duration of the trial.

Participants must have measurable or evaluable disease by RECIST v1.1 or RANO.

I can swallow.

Exclusion Criteria

I have received a bone marrow or organ transplant from another person.

Serious and/or uncontrolled preexisting medical condition(s) that would preclude participation in this study.

Has received an experimental treatment in a clinical trial within the last 30 days or 5 half-lives, whichever is longer.

Treatment Details

Interventions

• Abemaciclib
• Dinutuximab
• Irinotecan
• Temozolomide

Trial Overview The study tests the safety and effectiveness of abemaciclib combined with other anti-cancer drugs (Irinotecan, Temozolomide, Dinutuximab, GM-CSF) in participants who have cancer that's resistant to previous treatments. The trial will last up to two years per participant.

Participant Groups

Group I: Part C Stage 2: Abemaciclib in Combination with Dinutuximab, GM-CSF, Irinotecan, and Temozolomide Experimental Treatment 5 Interventions

Abemaciclib given orally, dinutuximab given IV, GM-CSF given subQ, irinotecan given IV and temozolomide given orally or IV.

Group II: Part C Stage 1: Abemaciclib in Combination with Dinutuximab, GM-CSF, Irinotecan, and Temozolomide Experimental Treatment 5 Interventions

Abemaciclib given orally, dinutuximab given IV, granulocyte macrophage colony-stimulating factor (GM-CSF) given subcutaneously (subQ), irinotecan given IV and temozolomide given orally or IV.

Group III: Dose Expansion: Abemaciclib + Temozolomide Experimental Treatment 2 Interventions

Abemaciclib and temozolomide given orally.

Group IV: Dose Expansion: Abemaciclib + Irinotecan + Temozolomide Experimental Treatment 3 Interventions

Abemaciclib given orally, irinotecan given IV and temozolomide given orally.

Group V: Dose Escalation: Abemaciclib + Temozolomide Experimental Treatment 2 Interventions

Abemaciclib and temozolomide given orally.

Group VI: Dose Escalation: Abemaciclib + Irinotecan + Temozolomide Experimental Treatment 3 Interventions

Abemaciclib given orally, irinotecan given intravenously (IV) and temozolomide given orally.

Abemaciclib is already approved in United States, European Union for the following indications:

Approved in United States as Verzenio for:

• Hormone receptor-positive (HR+), human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer
• HR+, HER2- node-positive early breast cancer

Approved in European Union as Verzenio for:

• HR+, HER2- advanced or metastatic breast cancer
• HR+, HER2- node-positive early breast cancer

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University