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Small Molecule

ONC201 for Glioblastoma

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will study the effects of a drug on adults with glioblastoma. Up to 36 patients will be treated with oral ONC201 twice weekly.

Eligible Conditions

Brain Tumor
Glioblastoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 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

Intra-tumoral ONC201 concentrations

Objective Response Rate

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%

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

2Treatment groups

Experimental Treatment

Group I: Arm B: ONC201 in GlioblastomaExperimental Treatment1 Intervention

Unequivocal evidence of recurrence (progressive disease) on contrast-enhanced brain CT or MRI as defined by RANO criteria, or have documented recurrent glioma on diagnostic biopsy. ONC201 will be administered orally, twice a week (2 consecutive days on and 5 days off per week) schedule at a dose of 625mg.

Group II: Arm A: ONC201 with Surgical Resection in GlioblastomaExperimental Treatment1 Intervention

Patients must be eligible for salvage surgical resection as deemed by the site Investigator. ONC201 will be administered orally, twice a week (2 consecutive days on and 5 days off per week) schedule at a dose of 625mg.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ONC-201

Not yet FDA approved

Do I qualify?Apply below to find out