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A Study of Ribociclib and Everolimus Following Radiation Therapy in Children With Newly Diagnosed Non-biopsied Diffuse Pontine Gliomas (DIPG) and RB+ Biopsied DIPG and High Grade Gliomas (HGG)

Phase 1
Waitlist Available
Research Sponsored by Children's Hospital Medical Center, Cincinnati
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 48 months
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions
No Placebo-Only Group

Summary

This trial is testing the safety of combining ribociclib and everolimus after radiation therapy in children and young adults with aggressive brain tumors. The drugs work by slowing down the growth of cancer cells. The goal is to find the safest dose and understand the effects on the body and tumor.

Eligible Conditions
  • Anaplastic Astrocytoma
  • Brain Cancer
  • Solid Tumors
  • Brain Tumor
  • Diffuse Intrinsic Pontine Glioma
  • Glioblastoma
  • Brain Stem Glioma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 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
Estimate the maximum tolerated dose and/or recommended phase 2 dose of ribociclib combined with everolimus
Number of adverse events
Pharmacokinetics of combination of ribociclib and everolimus
Secondary study objectives
Number of patients with observed pseudoprogression
Time from diagnosis to death - overall survival
Whole exome sequencing to explore biology of DIPG and HGG tumors

Side effects data

From 2020 Phase 3 trial • 502 Patients • NCT03096847
46%
NEUTROPENIA
43%
NAUSEA
38%
FATIGUE
33%
ALOPECIA
25%
NASOPHARYNGITIS
20%
LEUKOPENIA
20%
DIARRHOEA
20%
ASPARTATE AMINOTRANSFERASE INCREASED
19%
ARTHRALGIA
19%
ALANINE AMINOTRANSFERASE INCREASED
18%
CONSTIPATION
18%
ANAEMIA
17%
HEADACHE
17%
VOMITING
15%
NEUTROPHIL COUNT DECREASED
15%
STOMATITIS
14%
INSOMNIA
13%
PAIN IN EXTREMITY
13%
BACK PAIN
13%
DYSPNOEA
12%
HOT FLUSH
11%
THROMBOCYTOPENIA
11%
RASH
11%
OEDEMA PERIPHERAL
11%
DECREASED APPETITE
10%
URINARY TRACT INFECTION
10%
WHITE BLOOD CELL COUNT DECREASED
10%
COUGH
10%
PRURITUS
8%
ELECTROCARDIOGRAM QT PROLONGED
8%
DYSPEPSIA
8%
VERTIGO
8%
MUSCULOSKELETAL PAIN
8%
DRY SKIN
8%
GAMMA-GLUTAMYLTRANSFERASE INCREASED
6%
LACRIMATION INCREASED
6%
ABDOMINAL PAIN UPPER
6%
WEIGHT DECREASED
6%
ABDOMINAL PAIN
6%
PYREXIA
6%
BLOOD CREATININE INCREASED
6%
BONE PAIN
6%
DRY MOUTH
6%
ERYTHEMA
5%
DRY EYE
5%
DIZZINESS
4%
SLEEP DISORDER
4%
HYPERTENSION
4%
MYALGIA
4%
CYSTITIS
4%
DYSGEUSIA
4%
DEPRESSION
3%
GENERAL PHYSICAL HEALTH DETERIORATION
3%
BRONCHITIS
3%
MUSCULOSKELETAL CHEST PAIN
3%
POLYNEUROPATHY
2%
SEASONAL ALLERGY
2%
PLEURAL EFFUSION
2%
HYPOCALCAEMIA
1%
URETEROLITHIASIS
1%
SKIN ULCER
1%
ARTHROPOD BITE
1%
GASTROINTESTINAL INFECTION
1%
OROPHARYNGEAL PAIN
1%
INFLUENZA
1%
DEVICE RELATED INFECTION
1%
METASTASES TO SPINE
1%
CHEST PAIN
1%
CYSTITIS ESCHERICHIA
1%
SEPSIS
1%
INCISIONAL HERNIA
1%
COLON CANCER
1%
METASTASES TO BONE
1%
PULMONARY EMBOLISM
1%
ATRIAL FIBRILLATION
1%
ANAL HAEMORRHAGE
1%
HELICOBACTER GASTRITIS
1%
TUMOUR LYSIS SYNDROME
1%
TUMOUR PAIN
1%
WEIGHT INCREASED
1%
PANIC ATTACK
1%
FLANK PAIN
1%
SPINAL PAIN
1%
FEBRILE NEUTROPENIA
1%
CARDIAC FAILURE
1%
ILEUS
1%
INTESTINAL STRANGULATION
1%
COMPLICATION OF DEVICE INSERTION
1%
IMPAIRED HEALING
1%
PAIN
1%
HEPATIC CIRRHOSIS
1%
ABSCESS JAW
1%
APPENDICITIS
1%
MASTITIS
1%
PNEUMONIA
1%
HIP FRACTURE
1%
JAW FRACTURE
1%
RADIUS FRACTURE
1%
BLOOD BILIRUBIN INCREASED
1%
HYPERCALCAEMIA
1%
HYPERKALAEMIA
1%
DEVICE LOOSENING
1%
RENAL FAILURE
1%
RENAL IMPAIRMENT
1%
CIRCULATORY COLLAPSE
1%
TOOTHACHE
1%
BLOOD LACTATE DEHYDROGENASE INCREASED
1%
HYPOAESTHESIA
1%
HYPERFIBRINOLYSIS
1%
DRUG-INDUCED LIVER INJURY
1%
ABDOMINAL PAIN LOWER
1%
DEHYDRATION
1%
OSTEITIS
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ribociclib + Letrozole Cohort B2
Ribociclib + Letrozole Cohort A
Ribociclib + Letrozole Cohort B1
Total
Ribociclib + Letrozole Cohort B

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Group I: Dose level 3 (participants </= 21yrs)Experimental Treatment2 Interventions
Ribociclib administered orally; daily on days 1-21 each 28 day cycle; 170 mg/m2/day Everolimus administered orally; daily on days 1 - 28 each 28 day cycle; 1.5 mg/m2/day BSA \>/=0.45m2
Group II: Dose level 2 (participants </= 21yrs)Experimental Treatment2 Interventions
Ribociclib administered orally; daily on days 1-21 each 28 day cycle; 170 mg/m2/day Everolimus administered orally; daily on days 1 - 28 each 28 day cycle; 1.2 mg/m2/day BSA \>/=0.45m2
Group III: Dose level 1 (starting dose level) (participants </= 21yrs)Experimental Treatment2 Interventions
Ribociclib administered orally; daily on days 1-21 each 28 day cycle; dose calculation age dependent (\>21 yrs of age 300mg daily (DIPG only); \</=21 yrs of age 120 mg/m2/day) Everolimus administered orally; daily on days 1 - 28 each 28 day cycle; dose calculation age dependent (\>21yrs 2.5mg/day (DIPG only); \</=21yr 1.2 mg/m2/day) BSA \>/=0.75m2
Group IV: Dose level 1 (DIPG participants > 21yrs)Experimental Treatment2 Interventions
Ribociclib administered orally; daily on days 1-21 each 28 day cycle; 300mg daily Everolimus administered orally; daily on days 1 - 28 each 28 day cycle; 2.5mg/day
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ribociclib
FDA approved
Everolimus
FDA approved

Find a Location

Who is running the clinical trial?

NovartisIndustry Sponsor
1,638 Previous Clinical Trials
2,774,184 Total Patients Enrolled
Children's Hospital Medical Center, CincinnatiLead Sponsor
839 Previous Clinical Trials
6,565,598 Total Patients Enrolled
~2 spots leftby Dec 2025
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