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CDK4/6 Inhibitor

Abemaciclib Combination Therapy for Neuroblastoma

Phase 1 & 2
Waitlist Available
Research Sponsored by Eli Lilly and Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must have discontinued all previous treatments for cancer or investigational agents and must have recovered from the acute effects to Grade ≤1 at the time of enrollment.
Participants have a BSA ≥0.3 m².
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through progressive disease or death (estimated up to 24 months)
Awards & highlights

Study Summary

This trial is testing the safety and effectiveness of two different combinations of drugs for treating pediatric and young adult cancer patients who have not responded to other treatments.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system's response to the drugs which can affect various organs; gastrointestinal issues like nausea and diarrhea; blood-related problems such as anemia; fatigue; and potential increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have stopped all cancer treatments and recovered from major side effects.
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My body surface area is at least 0.3 square meters.
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My doctor expects me to live at least 8 weeks and I can complete a treatment cycle.
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My neuroblastoma has come back or did not respond to treatment.
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I'm sorry, but I need more information about the specific criteria in order to provide a summary. Could you please provide more details about the criteria you would like me to summarize?
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I am younger than 21 years old.
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I can do most activities but may need help, regardless of my age.
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I am 18 years old or younger.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through disease progression or death (estimated up to 24 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through disease progression or death (estimated up to 24 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number or Participants with Dose Limiting Toxicities (DLTs)
Magnetic Resonance Imaging
PK: Mean Steady State Concentrations of Irinotecan
+2 more
Secondary outcome measures
Acceptability Questionnaire
Chromium
Disease Control Rate (DCR): Percentage of Participants with a Best Overall Response of CR, PR, MR (Part C, only), and Stable Disease (SD)
+3 more

Side effects data

From 2018 Phase 2 trial • 132 Patients • NCT02102490
91%
Diarrhoea
67%
Nausea
48%
Fatigue
45%
Decreased appetite
35%
Vomiting
27%
Anaemia
26%
Abdominal pain
23%
Asthenia
23%
Neutrophil count decreased
21%
Cough
20%
Constipation
20%
Headache
19%
Arthralgia
18%
White blood cell count decreased
18%
Neutropenia
15%
Alopecia
14%
Platelet count decreased
14%
Dry mouth
14%
Weight decreased
14%
Dysgeusia
13%
Dyspnoea
12%
Abdominal pain upper
12%
Back pain
12%
Dizziness
11%
Pyrexia
11%
Dyspepsia
11%
Oedema peripheral
11%
Blood creatinine increased
10%
Pain
9%
Stomatitis
9%
Aspartate aminotransferase increased
8%
Dry skin
8%
Thrombocytopenia
8%
Pruritus
8%
Lacrimation increased
8%
Dehydration
8%
Alanine aminotransferase increased
7%
Flatulence
7%
Urinary tract infection
7%
Upper respiratory tract infection
7%
Hypokalaemia
6%
Chills
6%
Musculoskeletal chest pain
6%
Musculoskeletal pain
6%
Anxiety
5%
Rash
5%
Gastrooesophageal reflux disease
5%
Myalgia
2%
Cellulitis
2%
Pleural effusion
1%
Atypical pneumonia
1%
Gastroenteritis viral
1%
Sepsis
1%
Hip fracture
1%
Pneumonitis
1%
Fall
1%
Lung infection
1%
Pneumothorax
1%
Febrile neutropenia
1%
Respiratory tract infection
1%
Haematotoxicity
1%
Sinus bradycardia
1%
Tachycardia
1%
Large intestinal obstruction
1%
Pancreatic enzyme abnormality
1%
Pancreatitis
1%
Varices oesophageal
1%
Electrocardiogram abnormal
1%
Liver function test abnormal
1%
Renal function test abnormal
1%
Bone pain
1%
Muscular weakness
1%
Acute kidney injury
1%
Pulmonary embolism
1%
Arterial thrombosis
1%
Epilepsy
100%
80%
60%
40%
20%
0%
Study treatment Arm
Abemaciclib

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
GM-CSF
2014
Completed Phase 4
~1340
Abemaciclib
2019
Completed Phase 2
~1710
Irinotecan
2017
Completed Phase 4
~2680
Temozolomide
2010
Completed Phase 3
~1930
Dinutuximab
2009
Completed Phase 3
~710

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,624 Previous Clinical Trials
3,216,807 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,349 Previous Clinical Trials
415,563 Total Patients Enrolled

Media Library

Abemaciclib (CDK4/6 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04238819 — Phase 1 & 2
Solid Tumors Research Study Groups: Dose Expansion: Abemaciclib + Temozolomide, Part C Stage 1: Abemaciclib in Combination with Dinutuximab, GM-CSF, Irinotecan, and Temozolomide, Part C Stage 2: Abemaciclib in Combination with Dinutuximab, GM-CSF, Irinotecan, and Temozolomide, Dose Expansion: Abemaciclib + Irinotecan + Temozolomide, Dose Escalation: Abemaciclib + Irinotecan + Temozolomide, Dose Escalation: Abemaciclib + Temozolomide
Solid Tumors Clinical Trial 2023: Abemaciclib Highlights & Side Effects. Trial Name: NCT04238819 — Phase 1 & 2
Abemaciclib (CDK4/6 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04238819 — Phase 1 & 2
~60 spots leftby May 2028
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