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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

Study 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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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%
Vaginal hemorrhage
10%
Sepsis
10%
Lethargy
10%
Proteinuria
10%
Pleural effusion
10%
Pain
10%
Paresthesia
10%
Vaginal discharge
10%
Edema limbs
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)

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

Find a Location

Who is running the clinical trial?

ChimerixLead Sponsor
41 Previous Clinical Trials
4,139 Total Patients Enrolled
4 Trials studying Glioblastoma
447 Patients Enrolled for Glioblastoma
Masonic Cancer Center, University of MinnesotaLead Sponsor
274 Previous Clinical Trials
14,791 Total Patients Enrolled
1 Trials studying Glioblastoma
8 Patients Enrolled for Glioblastoma
University of MinnesotaOTHER
1,386 Previous Clinical Trials
1,552,380 Total Patients Enrolled

Media Library

ONC201 (Small Molecule) Clinical Trial Eligibility Overview. Trial Name: NCT04629209 — Phase 2
Glioblastoma Research Study Groups: Arm A: ONC201 with Surgical Resection in Glioblastoma, Arm B: ONC201 in Glioblastoma
Glioblastoma Clinical Trial 2023: ONC201 Highlights & Side Effects. Trial Name: NCT04629209 — Phase 2
ONC201 (Small Molecule) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04629209 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any open enrollment slots available for this experiment?

"The records on clinicaltrials.gov reveal that this research is not taking new participants at the moment, as it was initially published in February 15th 2021 and last modified April 28st 2021. Nevertheless, there are currently 473 other trials actively seeking subjects to join their studies."

Answered by AI

What is the risk profile associated with Arm A: ONC201 in combination with Surgical Resection for Glioblastoma patients?

"ONC201 with Surgical Resection in Glioblastoma was assigned a safety score of two due to the current Phase 2 trial. Although there is supportive data for its security, no evidence has been presented demonstrating efficacy."

Answered by AI

What is the cap on the number of participants in this trial?

"At this current moment, the medical trial is not actively seeking participants. First posted on February 15th 2021, it was last updated on April 28th 2021. If you are searching for other trials concerning glioblastoma, 465 studies and 8 specific to Arm A: ONC201 with Surgical Resection in Glioblastoma are currently enrolling patients."

Answered by AI

Is this experimentation novel to the medical field?

"The investigation of Arm A: ONC201 with Surgical Resection in Glioblastoma commenced circa 2015, sponsored by Oncoceutics, Inc.. After the initial trial involving 120 patients was concluded, Phase 1 & 2 approval for this drug was granted. Presently 8 different trials are active throughout 31 cities and 6 nations."

Answered by AI

To what extent have there been prior experiments involving Arm A: ONC201 combined with Surgical Resection in Glioblastoma?

"Currently, 8 clinical trials for Arm A: ONC201 with Surgical Resection in Glioblastoma are running; however, none of them have advanced to Phase 3. The primary site is located in Miami, Florida but there are 56 additional locations that are offering this medication."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Phase II, Open Label Study of ONC201 in Adults With EGFR-low Glioblastoma
2024. "A Phase II, Open Label Study of ONC201 in Adults With EGFR-low Glioblastoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04629209.
~0 spots leftby Dec 2024
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