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Dopamine Receptor D2 Antagonist

ONC201 for Neuroendocrine Tumors

Phase 2
Waitlist Available
Led By Peter M Anderson, MD, PhD
Research Sponsored by Peter Anderson
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 1 year
Awards & highlights

Study Summary

This trial is testing a new drug to see if it can make tumors smaller or make them go away completely. The drug is also being tested to see if it can prevent new cancer deposits from appearing.

Eligible Conditions
  • Neuroendocrine Tumors

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Neoplasms
Secondary outcome measures
Average change in anti-hypertensive medication
Average duration of lack of progression: Clinical response
Overall 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%
Sepsis
10%
Lethargy
10%
Proteinuria
10%
Pain
10%
Paresthesia
10%
Pleural effusion
10%
Vaginal hemorrhage
10%
Edema limbs
10%
Vaginal discharge
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

1Treatment groups
Experimental Treatment
Group I: ONC201 phase 2 d1d2 weekly cohortExperimental Treatment1 Intervention
625 mg ONC201 by mouth daily for 2 consecutive days weekly
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?

Peter AndersonLead Sponsor
Peter M Anderson, MD, PhDPrincipal InvestigatorCleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Frequently Asked Questions

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

Who else is applying?

What state do they live in?
New York
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
NeoplasiaJournal
Efficacy of ONC201 in Desmoplastic Small Round Cell Tumor
Hayes-Jordan, Andrea A., Xiao Ma, Brian A. Menegaz, Salah-Eddine Lamhamedi-Cherradi, Charles V. Kingsley, Jalen A. Benson, Pamela E. Camacho, et al.. 2018. “Efficacy of ONC201 in Desmoplastic Small Round Cell Tumor”. Neoplasia. Elsevier BV. doi:10.1016/j.neo.2018.02.006.
Health CommunicationJournal
Defining Moments: Making Time for Virtual Visits and Catalyzing Better Cancer Care
Anderson, Peter M., and Rabi Hanna. 2019. “Defining Moments: Making Time for Virtual Visits and Catalyzing Better Cancer Care”. Health Communication. Informa UK Limited. doi:10.1080/10410236.2019.1587695.
Science Translational MedicineJournal
Dual Inactivation of Akt and ERK by TIC10 Signals Foxo3a Nuclear Translocation, TRAIL Gene Induction, and Potent Antitumor Effects
Allen, Joshua E., Gabriel Krigsfeld, Patrick A. Mayes, Luv Patel, David T. Dicker, Akshal S. Patel, Nathan G. Dolloff, et al.. 2013. “Dual Inactivation of Akt and ERK by TIC10 Signals Foxo3a Nuclear Translocation, TRAIL Gene Induction, and Potent Antitumor Effects”. Science Translational Medicine. American Association for the Advancement of Science (AAAS). doi:10.1126/scitranslmed.3004828.
OncotargetJournal
Discovery and Clinical Introduction of First-in-class Imipridone ONC201
Allen, Joshua E., C. Leah B. Kline, Varun V. Prabhu, Jessica Wagner, Jo Ishizawa, Neel Madhukar, Avital Lev, et al.. 2016. “Discovery and Clinical Introduction of First-in-class Imipridone ONC201”. Oncotarget. Impact Journals, LLC. doi:10.18632/oncotarget.11814.
~4 spots leftby Apr 2025
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