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CDK 4/6 Inhibitor

Abemaciclib in Children With DIPG or Recurrent/Refractory Solid Tumors (AflacST1501 Trial)

Phase 1
Waitlist Available
Led By Thomas Cash, MD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up end of study (up to two years)
Awards & highlights
No Placebo-Only Group

Summary

This trial is studying how well abemaciclib works in treating patients with newly diagnosed diffuse intrinsic pontine glioma or relapsed/refractory/progressive malignant brain and solid tumors.

Eligible Conditions
  • Diffuse Intrinsic Pontine Glioma
  • Cancer
  • Brain Tumor
  • Osteosarcoma
  • Ewing Sarcoma
  • Solid Tumors
  • Neuroblastoma
  • Brain Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~end of study (up to two years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and end of study (up to two years) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Abemaciclib Maximum Tolerated Dose (MTD) for Diffuse Intrinsic Pontine Glioma (DIPG)
Abemaciclib Maximum Tolerated Dose (MTD) for Recurrent/Refractory Solid Tumors
Secondary study objectives
Number of hematological toxicities
Number of non-hematological toxicities
Number of participants with adverse events

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
9%
Stomatitis
9%
Aspartate aminotransferase increased
8%
Thrombocytopenia
8%
Lacrimation increased
8%
Dehydration
8%
Dry skin
8%
Pruritus
8%
Alanine aminotransferase increased
7%
Flatulence
7%
Upper respiratory tract infection
7%
Urinary tract infection
7%
Hypokalaemia
6%
Chills
6%
Musculoskeletal chest pain
6%
Musculoskeletal pain
6%
Anxiety
5%
Gastrooesophageal reflux disease
5%
Rash
5%
Myalgia
2%
Cellulitis
2%
Pleural effusion
1%
Atypical pneumonia
1%
Gastroenteritis viral
1%
Lung infection
1%
Sepsis
1%
Fall
1%
Hip fracture
1%
Pneumonitis
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Stratum B - enrollment is closed for this study armExperimental Treatment1 Intervention
Abemaciclib (LY2835219) will be administered orally on a twice daily basis continuously for 28 days, which defines one cycle. The maximum treatment duration will be 2 years. Investigators plan to treat a maximum of 4 cohorts of research participants (dosage levels 1, 2, 3, and 4) with escalating doses of abemaciclib starting with dose level 1 (80% of adult dose). Dose escalation will be independent of Stratum A escalation. A cycle is defined as 28 days and the first 4 weeks of therapy will constitute the DLT-evaluation period. Participants must take abemaciclib by mouth as intact capsules.
Group II: Stratum AExperimental Treatment1 Intervention
Appropriate dose RT will be administered in 30-33 fractions over approximately 6 weeks for Stratum A patients. Treatment with abemaciclib (LY2835219) will start on the same day as RT and continue twice daily during and after RT for a maximum treatment duration of 2 years. Investigators plan to treat a maximum of 4 cohorts of research participants (dosage levels 1, 2, 3, and 4) with escalating doses of abemaciclib (LY2835219) starting with dose level 1 (80% of adult dose). A cycle is defined as 28 days and the first 6 weeks of therapy will constitute the dose-limiting toxicity (DLT)-evaluation period. Participants must take abemaciclib by mouth as intact capsules.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abemaciclib
2019
Completed Phase 2
~1890

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor
1,708 Previous Clinical Trials
2,607,431 Total Patients Enrolled
2 Trials studying Diffuse Intrinsic Pontine Glioma
158 Patients Enrolled for Diffuse Intrinsic Pontine Glioma
Thomas Cash, MDPrincipal Investigator - Emory University
Medical School - New York University, Doctor of Medicine
Tufts-New England Medical Center, Residency in Physical Medicine and Rehabilitation
2 Previous Clinical Trials
105 Total Patients Enrolled

Media Library

Abemaciclib (CDK 4/6 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02644460 — Phase 1
Diffuse Intrinsic Pontine Glioma Research Study Groups: Stratum B - enrollment is closed for this study arm, Stratum A
Diffuse Intrinsic Pontine Glioma Clinical Trial 2023: Abemaciclib Highlights & Side Effects. Trial Name: NCT02644460 — Phase 1
Abemaciclib (CDK 4/6 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02644460 — Phase 1
~5 spots leftby Dec 2025
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