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NCT03099499 · ClinicalTrials.gov registry record · Phase 2
Single Agent ONC201 in Recurrent or Metastatic Endometrial Cancer
A Phase 2 study, sponsored by Fox Chase Cancer Center.
- Terminated
- Registry status
- Phase 2
- Development phase
- 19
- Enrollment target
NCT03099499: Clinical Trial Phase 2 study, sponsored by Fox Chase Cancer Center.
NCT03099499 is a Phase 2 study that was terminated before completion, run by Fox Chase Cancer Center. The registered enrollment target is 19 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03099499, a Phase 2 study, was terminated before completion, sponsored by Fox Chase Cancer Center.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 19 participants
- Enrollment target
Study Summary
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.
Primary Outcome
PFS will be calculated from the day of starting the treatment until 12 weeks
Interventions
- DRUG ONC201
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2017-06-08 |
| Est. Completion | 2020-09-09 |
| Phase | Phase 2 |
Why NCT03099499 stopped before completion
NCT03099499 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 1 intervention - of which ONC201 is the first listed.
NCT03099499 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03099499 about?
NCT03099499 is a clinical study titled "Single Agent ONC201 in Recurrent or Metastatic Endometrial Cancer". 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...
What is the current status of trial NCT03099499?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 19 participants. The study started on 2017-06-08. Estimated completion is 2020-09-09.
What interventions are being tested in trial NCT03099499?
The interventions under investigation include: ONC201 (DRUG).
Who is sponsoring clinical trial NCT03099499?
This trial is sponsored by Fox Chase Cancer Center, which has 183 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03099499's enrollment target sits among peer trials
19 1894th of 2000 higher than 103 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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