Abemaciclib Combination Therapy for Neuroblastoma

Recruiting in Palo Alto (17 mi)

+62 other locations

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Eli Lilly and Company

No Placebo Group

Breakthrough Therapy

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.

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.

+15 more

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.

+10 more

Participant Groups

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.

6Treatment groups

Experimental Treatment

Group I: Part C Stage 2: Abemaciclib in Combination with Dinutuximab, GM-CSF, Irinotecan, and TemozolomideExperimental Treatment5 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 TemozolomideExperimental Treatment5 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 + TemozolomideExperimental Treatment2 Interventions

Abemaciclib and temozolomide given orally.

Group IV: Dose Expansion: Abemaciclib + Irinotecan + TemozolomideExperimental Treatment3 Interventions

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

Group V: Dose Escalation: Abemaciclib + TemozolomideExperimental Treatment2 Interventions

Abemaciclib and temozolomide given orally.

Group VI: Dose Escalation: Abemaciclib + Irinotecan + TemozolomideExperimental Treatment3 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: