NCT03099499 is a Phase 2 clinical trial of ONC201 in Endometrial Cancer, sponsored by Fox Chase Cancer Center.

Who is sponsoring NCT03099499?

NCT03099499 is sponsored by Fox Chase Cancer Center.

What drugs are being tested in NCT03099499?

Interventions in NCT03099499: ONC201.

What condition does NCT03099499 study?

NCT03099499 studies Endometrial Cancer.

Is NCT03099499 still recruiting?

NCT03099499 is currently terminated. Last updated 24 December 2024.

Last reviewed 2024-12-24 · How we verify

NCT03099499

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Single Agent ONC201 in Recurrent or Metastatic Endometrial Cancer

Terminated Phase 2 Last updated 24 December 2024

What this trial tests

Phase 2 trial testing ONC201 in Endometrial Cancer in 19 participants. Terminated before completion.

Timeline

8 June 2017

Primary endpoint
9 September 2020

9 September 2020

Quick facts

Lead sponsor	Fox Chase Cancer Center
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	19
Start date	8 June 2017
Primary completion	9 September 2020
Estimated completion	9 September 2020
Sites	1 location across United States

Drugs / interventions tested

ONC201 — full drug profile →

Conditions studied

Endometrial Cancer — all drugs for Endometrial Cancer →

Sponsor

Fox Chase Cancer Center — full company profile →

Who can join

18 and older, female only, with Endometrial Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

ONC201 is a small molecule which selectively targets the G protein-coupled receptor DRD2. Downstream of target engagement, ONC201 activates the integrated stress response (ISR) in tumor cell leading to inactivation of Akt and extracellular signal-regulated kinase (ERK) signaling as well as induction of the TRAIL pathway. ONC201 also inhibits dopamine receptor 2 (DRD2), resulting in anti-tumor responses in preclinical models. Single agent ONC201 has been examined in open-label Phase I studies in patients with advanced, treatment refractory solid malignancies. Due to its differential anti-proliferative and pro-apoptotic response in tumor cells, treatment was overall well tolerated, and the recommended phase II dose of ONC201 was set at 625mg every three weeks. An additional dose-escalation phase I study (NCT02609230) is further evaluating weekly versus three week dosing in patients with advanced solid tumors and multiple myeloma. Preliminary data from these phase I studies suggests a possible clinical benefit in patients with advanced, chemo-refractory endometrial cancers, with at least one mixed response noted in a patient with clear cell histology. Hypothesis: Single agent ONC201 will demonstrate clinical benefit in women with recurrent or metastatic endometrial cancers, especially in those women with alterations in the Phosphoinositide 3 kinase (PI3K)/Akt/mammalian target of Rapamycin (mTOR) pathway.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Targeting apoptosis in cancer therapy.
Carneiro BA, El-Deiry WS. · · 2020 · cited 1823× · PMID 32203277 · DOI 10.1038/s41571-020-0341-y
Developing TRAIL/TRAIL death receptor-based cancer therapies.
Yuan X, Gajan A, Chu Q, Xiong H, et al · · 2018 · cited 200× · PMID 29541897 · DOI 10.1007/s10555-018-9728-y
ONC201 and imipridones: Anti-cancer compounds with clinical efficacy.
Prabhu VV, Morrow S, Rahman Kawakibi A, Zhou L, et al · · 2020 · cited 137× · PMID 33142238 · DOI 10.1016/j.neo.2020.09.005
Novel Apoptosis-Inducing Agents for the Treatment of Cancer, a New Arsenal in the Toolbox.
Lim B, Greer Y, Lipkowitz S, Takebe N. · · 2019 · cited 61× · PMID 31370269 · DOI 10.3390/cancers11081087
Safety and enhanced immunostimulatory activity of the DRD2 antagonist ONC201 in advanced solid tumor patients with weekly oral administration.
Stein MN, Malhotra J, Tarapore RS, Malhotra U, et al · · 2019 · cited 60× · PMID 31118108 · DOI 10.1186/s40425-019-0599-8
Dopamine Receptor D5 is a Modulator of Tumor Response to Dopamine Receptor D2 Antagonism.
Prabhu VV, Madhukar NS, Gilvary C, Kline CLB, et al · · 2019 · cited 51× · PMID 30559168 · DOI 10.1158/1078-0432.ccr-18-2572
Mechanisms of imipridones in targeting mitochondrial metabolism in cancer cells.
Bonner ER, Waszak SM, Grotzer MA, Mueller S, et al · · 2021 · cited 50× · PMID 33336683 · DOI 10.1093/neuonc/noaa283
A review of current therapeutics targeting the mitochondrial protease ClpP in diffuse midline glioma, H3 K27-altered.
Jackson ER, Persson ML, Fish CJ, Findlay IJ, et al · · 2024 · cited 30× · PMID 37589388 · DOI 10.1093/neuonc/noad144

Verify or expand the search:

Other trials of ONC201

Trials testing the same drug.

NCT04629209 — A Phase II, Open Label Study of ONC201 in Adults With EGFR-low Glioblastoma · Phase 2 · withdrawn
NCT05542407 — ONC201 and Atezolizumab in Obesity-Driven Endometrial Cancer · Phase 1 · recruiting
NCT05009992 — Combination Therapy for the Treatment of Diffuse Midline Gliomas · Phase 2 · recruiting
NCT03492138 — Ixazomib, ONC201, and Dexamethasone in Relapsed/Refractory Multiple Myeloma · Phase 1, PHASE2 · terminated
NCT03394027 — ONC201 in Recurrent/Refractory Metastatic Breast Cancer and Advanced Endometrial Carcinoma · Phase 2 · completed

Other recruiting trials for Endometrial Cancer

Currently open trials in the same condition.

NCT07419841 — A Phase 1 Study of the Safety and Tolerability of CTX-10726 · Phase 1 · recruiting
NCT07382583 — Development of a Shared Decision Tool to Facilitate Uptake of the Levonorgestrel-releasing Intrauterine System for the P · recruiting
NCT07377734 — Intrauterine Injection of Type III Collage in FST of EC/AEH · Phase 2 · recruiting
NCT07319429 — Refining Fertility-sparing Treatment in Endometrial Carcinoma Based on Molecular Classification · Phase 2, PHASE3 · recruiting
NCT07397624 — Endoscopic Suture Gastroplasty (ESG) for Treatment of Obese Patients With Endometrial Cancer · recruiting

Other Fox Chase Cancer Center trials

Trials by the same sponsor.

NCT07455032 — Neoadjuvant CADI-05 in Combination With Pembrolizumab for Surgically Resectable Locally Advanced Head and Neck Squamous · Phase 1 · recruiting
NCT07221942 — Pembrolizumab Maintenance After Enfortumab Vedotin (EV)/Pembro Induction in Front-Line Metastatic Urothelial Carcinoma · Phase 2 · recruiting
NCT07221058 — Adaptive Radiation Boost for Rectal Cancer · Phase 1 · recruiting
NCT07167446 — Neuroprotective Potential of Cannabidiol (CBD) in Preventing Oxaliplatin (Ox)-Induced Neuropathy · EARLY_PHASE1 · recruiting
NCT07219303 — Adaptive Radiation Therapy for Men With Intermediate- or High-Risk Prostate Cancer · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03099499 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Fox Chase Cancer Center
Last refreshed: 24 December 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03099499.

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