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NCT05618613 · ClinicalTrials.gov registry record · Phase 1
Study of Elacestrant in Combination With Onapristone in Patients With Advanced or Metastatic Breast Cancer
A Phase 1 study, sponsored by Context Therapeutics.
- Terminated
- Registry status
- Phase 1
- Development phase
- 4
- Enrollment target
NCT05618613: Clinical Trial Phase 1 study, sponsored by Context Therapeutics.
NCT05618613 is a Phase 1 study that was terminated before completion, run by Context Therapeutics. The registered enrollment target is 4 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05618613, a Phase 1 study, was terminated before completion, sponsored by Context Therapeutics.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 4 participants
- Enrollment target
Study Summary
This is a multicenter, Phase 1b-2 study of elacestrant in combination with onapristone in patients with advanced/metastatic ER+/PgR+/HER2- breast cancer.
Primary Outcome
DLTs were pre-specified toxicities occurring during Cycle 1 (28 days) and considered at least possibly related to study treatment, based on CTCAE criteria. Assessment of safety and tolerability to determine the recommended Phase 2 dose (RP2D). DLT defined as dose associated with \<33% of patients experiencing DLT (≤1 patient out of 6 DLT-evaluable patients).
Interventions
- DRUG Elacestrant
- DRUG Onapristone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2022-12-02 |
| Est. Completion | 2023-06-23 |
| Phase | Phase 1 |
Why NCT05618613 stopped before completion
NCT05618613 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 2 interventions - of which Elacestrant is the first listed.
NCT05618613 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05618613 about?
NCT05618613 is a clinical study titled "Study of Elacestrant in Combination With Onapristone in Patients With Advanced or Metastatic Breast Cancer". This is a multicenter, Phase 1b-2 study of elacestrant in combination with onapristone in patients with advanced/metastatic ER+/PgR+/HER2- breast cancer.
What is the current status of trial NCT05618613?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 4 participants. The study started on 2022-12-02. Estimated completion is 2023-06-23.
What interventions are being tested in trial NCT05618613?
The interventions under investigation include: Elacestrant (DRUG), Onapristone (DRUG).
Who is sponsoring clinical trial NCT05618613?
This trial is sponsored by Context Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05618613's enrollment target sits among peer trials
4 1995th of 2000 higher than 2 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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