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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
Participants have had no previous treatment except corticosteroid use.
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 Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
You haven't received any treatment except for corticosteroids.
AflacST1501 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ cycle 1 to end of study (up to two years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~cycle 1 to end of study (up to two years)
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 moreSecondary 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 • NCT0210249091%
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%
Neutropenia
18%
White blood cell count decreased
15%
Alopecia
14%
Weight decreased
14%
Dry mouth
14%
Platelet count decreased
14%
Dysgeusia
13%
Dyspnoea
12%
Abdominal pain upper
12%
Back pain
12%
Dizziness
11%
Dyspepsia
11%
Oedema peripheral
11%
Pyrexia
11%
Blood creatinine increased
10%
Pain
9%
Stomatitis
9%
Aspartate aminotransferase increased
8%
Thrombocytopenia
8%
Lacrimation increased
8%
Alanine aminotransferase increased
8%
Dehydration
8%
Dry skin
8%
Pruritus
7%
Upper respiratory tract infection
7%
Urinary tract infection
7%
Flatulence
7%
Hypokalaemia
6%
Chills
6%
Musculoskeletal chest pain
6%
Musculoskeletal pain
6%
Anxiety
5%
Gastrooesophageal reflux disease
5%
Myalgia
5%
Rash
2%
Cellulitis
2%
Pleural effusion
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%
Atypical pneumonia
1%
Gastroenteritis viral
1%
Lung infection
1%
Sepsis
1%
Fall
1%
Hip fracture
1%
Electrocardiogram abnormal
1%
Liver function test abnormal
1%
Renal function test abnormal
1%
Bone pain
1%
Muscular weakness
1%
Acute kidney injury
1%
Pneumonitis
1%
Pneumothorax
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
~1550
Find a Location
Who is running the clinical trial?
Emory UniversityLead Sponsor
1,627 Previous Clinical Trials
2,560,712 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have an infection that is not under control.You are currently taking other cancer medications or experimental drugs.You haven't received any treatment except for corticosteroids.You have received treatment with abemaciclib in the past.
Research Study Groups:
This trial has the following groups:- Group 1: Stratum B - enrollment is closed for this study arm
- Group 2: Stratum A
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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