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CDK 4/6 Inhibitor

Abemaciclib for Diffuse Intrinsic Pontine Glioma (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

AflacST1501 Trial 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
  • Solid Tumors
  • Neuroblastoma
  • Ewing Sarcoma
  • Rhabdomyosarcoma
  • Osteosarcoma
  • Rhabdoid Tumor
  • Brain Cancer

AflacST1501 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~cycle 1 to end of study (up to two years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and cycle 1 to end of study (up to two years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Abemaciclib Maximum Tolerated Dose (MTD) for Diffuse Intrinsic Pontine Glioma (DIPG)
Abemaciclib Maximum Tolerated Dose (MTD) for Recurrent/Refractory Solid Tumors
Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of Abemaciclib
+2 more
Secondary outcome measures
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%
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

AflacST1501 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
~1710

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor
1,642 Previous Clinical Trials
2,563,953 Total Patients Enrolled
1 Trials studying Diffuse Intrinsic Pontine Glioma
140 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Expert Opinion on Emerging DrugsJournal
An Update on Emerging Drugs in Osteosarcoma: Towards Tailored Therapies?
Hattinger, Claudia Maria, Maria Pia Patrizio, Federica Magagnoli, Silvia Luppi, and Massimo Serra. 2019. “An Update on Emerging Drugs in Osteosarcoma: Towards Tailored Therapies?”. Expert Opinion on Emerging Drugs. Informa UK Limited. doi:10.1080/14728214.2019.1654455.
clinicaltrials.govStudy
Abemaciclib in Children With DIPG or Recurrent/Refractory Solid Tumors
Thomas Cash 2016. "Abemaciclib in Children With DIPG or Recurrent/Refractory Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02644460.
~6 spots leftby May 2025
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