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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
  • 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 2021 Phase 2 trial • 30 Patients • NCT03394027
60%
Fatigue
40%
Alkaline phosphatase increased
40%
Aspartate aminotransferase increased
40%
Lymphocyte count decreased
40%
Dizziness
30%
Alanine aminotransferase increased
30%
Diarrhea
20%
Hypophosphatemia
20%
Abdominal pain
20%
Anemia
20%
Nausea
20%
Dyspnea
10%
Edema limbs
10%
Paresthesia
10%
Vaginal discharge
10%
Pain
10%
Sepsis
10%
Lethargy
10%
Vaginal hemorrhage
10%
Proteinuria
10%
Pleural effusion
10%
Flu like symptoms
10%
Gastroesophageal reflux disease
10%
Headache
10%
Atrial flutter
10%
Cardiac arrest
10%
Dehydration
10%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, Death
10%
Sinus tachycardia
10%
Stroke
10%
Thromboembolic event
10%
Urinary tract infection
10%
Anorexia
10%
Arthralgia
10%
Back pain
10%
Constipation
10%
Lymphedema
10%
Malaise
10%
Mucosal infection
10%
Myalgia
10%
Rash maculo-papular
10%
Rhinorrhea
10%
Vascular access complication
10%
Weight loss
10%
Cough
10%
Creatinine increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 3-Endometrial Cancer (Female Only)
Cohort 1-Hormone Receptor (HR) + Breast Cancer (Male and Female)
Cohort 2-Triple Negative Breast Cancer (Male and Female)

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
Brain Tumor 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
Brain Tumor 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 Nov 2025
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