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ribociclib for Brain Tumor

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

Brain Cancer
Brain Tumor
Diffuse Intrinsic Pontine Glioma
Anaplastic Astrocytoma
Glioblastoma
Brain Stem Glioma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 48 months

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%

RASH

11%

THROMBOCYTOPENIA

11%

OEDEMA PERIPHERAL

11%

DECREASED APPETITE

10%

URINARY TRACT INFECTION

10%

WHITE BLOOD CELL COUNT DECREASED

10%

COUGH

10%

PRURITUS

ELECTROCARDIOGRAM QT PROLONGED

DYSPEPSIA

VERTIGO

MUSCULOSKELETAL PAIN

DRY SKIN

GAMMA-GLUTAMYLTRANSFERASE INCREASED

LACRIMATION INCREASED

ABDOMINAL PAIN UPPER

WEIGHT DECREASED

ABDOMINAL PAIN

PYREXIA

BLOOD CREATININE INCREASED

BONE PAIN

DRY MOUTH

ERYTHEMA

DRY EYE

DIZZINESS

SLEEP DISORDER

HYPERTENSION

MYALGIA

CYSTITIS

DYSGEUSIA

DEPRESSION

GENERAL PHYSICAL HEALTH DETERIORATION

BRONCHITIS

MUSCULOSKELETAL CHEST PAIN

POLYNEUROPATHY

SEASONAL ALLERGY

PLEURAL EFFUSION

HYPOCALCAEMIA

URETEROLITHIASIS

SKIN ULCER

ARTHROPOD BITE

GASTROINTESTINAL INFECTION

INFLUENZA

OROPHARYNGEAL PAIN

DEVICE RELATED INFECTION

METASTASES TO SPINE

CHEST PAIN

CYSTITIS ESCHERICHIA

SEPSIS

INCISIONAL HERNIA

COLON CANCER

METASTASES TO BONE

PULMONARY EMBOLISM

ATRIAL FIBRILLATION

ANAL HAEMORRHAGE

HELICOBACTER GASTRITIS

TUMOUR LYSIS SYNDROME

TUMOUR PAIN

WEIGHT INCREASED

PANIC ATTACK

FLANK PAIN

SPINAL PAIN

FEBRILE NEUTROPENIA

CARDIAC FAILURE

ILEUS

INTESTINAL STRANGULATION

COMPLICATION OF DEVICE INSERTION

IMPAIRED HEALING

PAIN

HEPATIC CIRRHOSIS

ABSCESS JAW

APPENDICITIS

MASTITIS

PNEUMONIA

HIP FRACTURE

JAW FRACTURE

RADIUS FRACTURE

BLOOD BILIRUBIN INCREASED

HYPERCALCAEMIA

HYPERKALAEMIA

DEVICE LOOSENING

RENAL FAILURE

RENAL IMPAIRMENT

CIRCULATORY COLLAPSE

TOOTHACHE

BLOOD LACTATE DEHYDROGENASE INCREASED

HYPOAESTHESIA

HYPERFIBRINOLYSIS

DRUG-INDUCED LIVER INJURY

ABDOMINAL PAIN LOWER

DEHYDRATION

OSTEITIS

100%

80%

60%

40%

20%

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

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