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Small Molecule

ONC201 for Multiple Myeloma

Phase 1 & 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 3 years

Awards & highlights

Study Summary

This trial is for a new cancer drug that has shown promise in early tests. It is given orally once a week, and is being studied in combination with another drug, dexamethasone, to see if it is effective in treating multiple myeloma.

Eligible Conditions

Multiple Myeloma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall 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%

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

1Treatment groups

Experimental Treatment

Group I: ONC201Experimental Treatment1 Intervention

Single agent ONC201.

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

4,118 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 people can take part in this research project?

"This study is not recruiting patients at the moment. It was originally posted on 1/1/2016, with the most recent update being 11/8/2022. There are 827 other trials related to multiple myeloma that are currently looking for participants, as well as 10 studies regarding ONC201."

Answered by AI

What are the unique aspects of this particular clinical trial?

"ONC201 is being studied in 10 active clinical trials across 4 nations and 29 cities. The first trial for this drug was sponsored by Oncoceutics, Inc. in 2015 and involved 120 participants. It completed Phase 1 & 2 of its drug approval process and since then, 4 more trials have been conducted."

Answered by AI

Are there any unfilled participant positions in this research project?

"According to the website clinicaltrials.gov, this study is not recruiting at present. The trial was originally posted on 1/1/2016 and last updated on 11/8/2022. However, 837 other trials are currently looking for participants."

Answered by AI

Is ONC201 a novel cancer treatment?

"Currently, there are 10 ongoing clinical studies involving ONC201. As this is a Phase 3 trial, 0 of those active trials have completed the investigational process. The majority of these research sites are located in Miami, however there are 47 different locations running trials for this medication."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Oral ONC201 in Relapsed/Refractory Multiple Myeloma

2016. "Oral ONC201 in Relapsed/Refractory Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02863991.

All > Myeloma