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Small Molecule

ONC201 for Brain Tumor

Phase 2
Waitlist Available
Research Sponsored by Chimerix
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial tests ONC201, a new type of treatment that has shown promise in fighting various cancers, including a specific type of brain cancer, in patients who have this cancer returning.

Eligible Conditions
  • Brain Tumor
  • Solid Tumors
  • Glioblastoma
  • Diffuse Midline Glioma
  • Thalamic Glioma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2023 Phase 2 trial • 30 Patients • NCT03034200
30%
Pain
30%
Hypercalcemia
20%
Fatigue
20%
Anemia
20%
Creatinine increased
20%
Headache
20%
Hypotension
10%
Dizziness
10%
Urticaria
10%
Vascular disorders - Other, specify: Diaphoresis
10%
General disorders and administration site conditions - Other, specify: Neck swelling
10%
Serum sickness
10%
Syncope
10%
Fall
10%
Fracture
10%
Sore throat
10%
Leukocytosis
10%
Chills
10%
Edema face
10%
Fever
10%
General disorders and administration site conditions - Other, specify - Hives
10%
Hypophosphatemia
10%
Dyspnea
10%
Surgical and medical procedures - Other, specify - Exploratory laparotomy of abdomen
10%
Alkaline phosphatase increased
10%
Anxiety
10%
Ascites
10%
Aspartate aminotransferase increased
10%
Atrial Flutter
10%
Bloating
10%
Bone pain
10%
Brachial plexopathy
10%
Cognitive disturbance
10%
Diarrhea
10%
Dysgeusia
10%
Flatulence
10%
Gastroesophageal reflux disease
10%
General disorders and administration site conditions - Other, specify: Facial swelling
10%
General disorders and administration site conditions - Other, specify: Hives
10%
Hot flashes
10%
Hypertension
10%
Insomnia
10%
Investigations - Other, specify: Aspartate aminotransferase decreased
10%
Nausea
10%
Neuralgia
10%
Platelet count decreased
10%
Cardiac disorders - Other, specify: Abnormal EKG
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm A: Metastatic PC-PG
Arm B: Other NETs
Arm C: PC-PG + Other NETs

Awards & Highlights

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

Trial Design

6Treatment groups
Experimental Treatment
Group I: F: Non-H3 K27M Diffuse Midline Glioma ONC201 Q1WExperimental Treatment1 Intervention
Group II: E: Diffuse Midline Glioma Surgical Cohort ONC201 Q1WExperimental Treatment1 Intervention
Group III: D: H3 K27M Glioma ONC201 Q1WExperimental Treatment1 Intervention
Group IV: C: GBM Surgical Cohort ONC201 Q1WExperimental Treatment1 Intervention
Group V: B: GBM ONC201 Q1WExperimental Treatment1 Intervention
Group VI: A: GBM ONC201 Q3WExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ONC201
2017
Completed Phase 2
~60

Find a Location

Who is running the clinical trial?

ChimerixLead Sponsor
41 Previous Clinical Trials
3,998 Total Patients Enrolled

Media Library

ONC201 (Small Molecule) Clinical Trial Eligibility Overview. Trial Name: NCT02525692 — Phase 2
Solid Tumors Research Study Groups: A: GBM ONC201 Q3W, B: GBM ONC201 Q1W, C: GBM Surgical Cohort ONC201 Q1W, D: H3 K27M Glioma ONC201 Q1W, E: Diffuse Midline Glioma Surgical Cohort ONC201 Q1W, F: Non-H3 K27M Diffuse Midline Glioma ONC201 Q1W
Solid Tumors Clinical Trial 2023: ONC201 Highlights & Side Effects. Trial Name: NCT02525692 — Phase 2
ONC201 (Small Molecule) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02525692 — Phase 2
~9 spots leftby Dec 2025
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