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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.

Must not have

Received allogenic bone marrow or solid organ transplant.

Prior treatment with drugs known to be strong inhibitors or inducers of isoenzyme cytochrome P450 3A (CYP3A) or strong inhibitors of uridine diphosphate-glucuronosyl transferase 1A1 (UGT1A1) if the treatment cannot be discontinued or switched to a different medication at least 5 half-lives prior to starting study drug.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline through measured progressive disease (estimated up to 24 months)

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I haven't taken strong drugs affecting liver enzymes recently.

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I do not have any ongoing infections or high viral levels.

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I haven't had cancer that could interfere with this study's results in the last 3 years, except for certain skin cancers or treated cervical/breast cancers.

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I have received a live vaccine recently.

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I have been treated with CDK 4 & 6 inhibitors before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline through progressive disease or death (estimated up to 24 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline through progressive disease or death (estimated up to 24 months)

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number or Participants with Dose Limiting Toxicities (DLTs)

Magnetic Resonance Imaging

PK: Mean Steady State Concentrations of Irinotecan

+2 more

Secondary study objectives

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%

Dry mouth

14%

Platelet count decreased

14%

Weight decreased

14%

Dysgeusia

13%

Dyspnoea

12%

Abdominal pain upper

12%

Back pain

12%

Dizziness

11%

Oedema peripheral

11%

Dyspepsia

11%

Pyrexia

11%

Blood creatinine increased

10%

Pain

Stomatitis

Aspartate aminotransferase increased

Thrombocytopenia

Lacrimation increased

Dehydration

Dry skin

Pruritus

Alanine aminotransferase increased

Flatulence

Upper respiratory tract infection

Urinary tract infection

Hypokalaemia

Chills

Musculoskeletal chest pain

Musculoskeletal pain

Anxiety

Gastrooesophageal reflux disease

Rash

Myalgia

Cellulitis

Pleural effusion

Atypical pneumonia

Gastroenteritis viral

Lung infection

Sepsis

Fall

Hip fracture

Pneumonitis

Pneumothorax

Febrile neutropenia

Respiratory tract infection

Haematotoxicity

Sinus bradycardia

Tachycardia

Large intestinal obstruction

Pancreatic enzyme abnormality

Pancreatitis

Varices oesophageal

Electrocardiogram abnormal

Liver function test abnormal

Renal function test abnormal

Bone pain

Muscular weakness

Acute kidney injury

Pulmonary embolism

Arterial thrombosis

Epilepsy

100%

80%

60%

40%

20%

Study treatment Arm

Abemaciclib

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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