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Small Molecule

ONC201 for Endometrial Cancer

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 2 months

Awards & highlights

Study Summary

This trial tests a new drug, ONC201, for women with endometrial cancer that has come back or spread after previous chemotherapy treatments.

Eligible Conditions

Endometrial Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 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

Progress-free survival

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%

Pain

10%

Lethargy

10%

Paresthesia

10%

Sepsis

10%

Proteinuria

10%

Pleural effusion

10%

Vaginal discharge

10%

Vaginal hemorrhage

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%

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

3Treatment groups

Experimental Treatment

Group I: Dosing twice per week on two consecutive daysExperimental Treatment1 Intervention

Group II: Biopsy-optionalExperimental Treatment1 Intervention

Group III: Biopsy-mandatedExperimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ONC201

2017

Completed Phase 2

~60

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

ChimerixLead Sponsor

41 Previous Clinical Trials

4,109 Total Patients Enrolled

Frequently Asked Questions

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

How many participants are being included in this experiment?

"Unfortunately, this particular clinical trial is not presently searching for new participants. The study was initially posted on 3/21/2018 and was last edited on 11/8/2022; however, there are other active trials that may be of interest. In total, 1339 relapse studies and 10 ONC201 studies are actively recruiting patients."

Answered by AI

Are there adverse effects to using ONC201?

"ONC201's safety is only backed by Phase 2 data, meaning that while there are some studies supporting its safety, none of them look at whether the drug actually works. This gives ONC201 a score of 2."

Answered by AI

What are the most similar clinical trials to ONC201 in terms of medications tested?

"Currently, there are 10 active clinical trials investigating the use of ONC201 for cancer treatment. None of these trials are in Phase 3 yet. Most of the studies for ONC201 are being conducted out of Miami, Florida, but there are a total of 47 locations running studies for ONC201."

Answered by AI

To your knowledge, does a similar study exist?

"To date, there have been 10 ONC201 clinical trials held in 29 cities and 4 countries. The first one was sponsored by Oncoceutics, Inc. and took place in 2015. It involved 120 patients and completed both Phase 1 & 2 of the drug approval process . In the years since then, 4 more trials have taken place."

Answered by AI

Are new participants being accepted into this clinical trial at this time?

"Unfortunately, this particular trial is not currently looking for any more patients. The study was posted on March 21st, 2018 and edited November 8th, 2022. However, there are plenty of other trials that may be a match for you; right now, 1339 clinical trials are actively admitting patients with relapse and 10 trials for ONC201 are actively recruiting participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

ONC201 in Recurrent or Metastatic Type II Endometrial Cancer Endometrial Cancer

2018. "ONC201 in Recurrent or Metastatic Type II Endometrial Cancer Endometrial Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03485729.