Trial · NCT05618613
Study of Elacestrant in Combination With Onapristone in Patients With Advanced or Metastatic Breast Cancer
NCT05618613, Phase 1, Phase 2, Terminated, Context Therapeutics Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Elacestrant in Combination With Onapristone in Patients With Advanced or Metastatic Breast Cancer. Trials, record NCT05618613. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05618613
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Elacestrant in Combination With Onapristone in Patients With Advanced or Metastatic Breast Cancer
- NCT number
- NCT05618613
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 4 participants, actual
- Lead sponsor
- Context Therapeutics Inc.
- Conditions
- Breast Cancer
- Interventions
- Elacestrant, Onapristone
- First posted
- 2022-11-16
- Last updated
- 2026-07-21
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Dose-Limiting Toxicities (DLTs) During First Cycle | First 28 days (Cycle 1) | 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). |
| Primary | Objective Response Rate (ORR) | Assessed every 8 weeks until disease progression, up to approximately 6 months | ORR was defined as the proportion of patients achieving confirmed complete or partial response per RECIST v1.1; Phase 2 was not initiated, and no patients were enrolled. |
| Secondary | Adverse Events (AEs) | From first dose until 30 days after last dose (up to 183 days) | Adverse events were collected from first dose through last safety assessment and graded using NCI CTCAE v5.0. Incidence and severity of AEs was collected. |
| Secondary | Serious Adverse Events (SAEs) | 183 days | Serious Adverse events were collected from first dose through last safety assessment and graded using NCI CTCAE v5.0. Incidence and severity of SAEs was collected |
| Secondary | Evaluate the Maximum Plasma Concentration (Cmax) of Elacestrant as Well as Onapristone and Their Metabolites (Phase 1) | 15 Days | AUC₀-ₜₐᵤ, Cₘₐₓ, Tₘₐₓ, and Cₜᵣₒᵤ for elacestrant, onapristone, and metabolites. PK samples were obtained from 2 patients at Cycle 1, Day 15 at the following timepoints: predose (hour 0), 1, 2, 3, 6, 8, 12, and 24 hours post-dose. Data was collected as represented below for 2 patients |
| Secondary | Evaluate the Time of the Maximum Observed Plasma Concentration (Tmax) of Elacestrant as Well as Onapristone and Their Metabolites (Phase 1). | 15 Days | AUC₀-ₜₐᵤ, Cₘₐₓ, Tₘₐₓ, and Cₜᵣₒᵤ for elacestrant, onapristone, and metabolites. PK samples were obtained from 2 patients at Cycle 1, Day 15 at the following timepoints: predose (hour 0), 1, 2, 3, 6, 8, 12, and 24 hours post-dose. Data was collected as represented below for 2 patients |
| Secondary | Evaluate Duration of Response | From first documented CR/PR until progression or death, up to 183 days | Time from first CR/PR until progression or death |
| Secondary | Evaluate Clinical Benefit Rate | 183 days | Proportion of subjects achieving a best overall or complete response, or durable stable disease (duration is at least 23 weeks) |
| Secondary | Evaluate Progression-free Survival | 183 Days | Time from the date of the first dose to the date of the first documentation of disease progression or death, whichever occurs first. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05618613
GET https://conductscience.org/api/trials/v1/NCT05618613/registered