Trial · NCT02052128
Phase 1-2 Study of Onapristone in Patients With Progesterone Receptor Expressing Cancers
NCT02052128, Phase 1, Phase 2, Unknown, Arno Therapeutics
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase 1-2 Study of Onapristone in Patients With Progesterone Receptor Expressing Cancers. Trials, record NCT02052128. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02052128
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 1-2 Study of Onapristone in Patients With Progesterone Receptor Expressing Cancers
- NCT number
- NCT02052128
- Status
- Unknown
- Phases
- Phase 1, Phase 2
- Enrollment
- 60 participants, estimated
- Lead sponsor
- Arno Therapeutics
- Conditions
- Progesterone Receptor Positive Tumor: Max 1 Line of Prior Chemotherapy, no Prior Hormone Therapy
- Interventions
- onapristone
- First posted
- 2014-01-31
- Last updated
- 2015-06-24
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Stage 1: RP2D of a single agent extended-release tablet formulation of oral onapristone for future clinical development. | Baseline to 57 days post-first dose | |
| Primary | Stage 2: ORR using RECIST 1.1 in 10-29 patients with recurrent or metastatic uterine endometrioid adenocarcinoma that is APRpos, and to determine the relationship between APR status and onapristone anti-tumor activity. | Baseline to 30 Days after last dose | |
| Secondary | Safety and tolerability of extended-release onapristone tablets BID and of immediate-release onapristone tablets QD | Baseline to 30 Days after last dose | Safety will be assessed by physical exam, vital signs, monitoring of adverse events, changes in ECG, and other clinical laboratory values |
| Secondary | Comparison of safety of extended-release BID vs. immediate release QD schedules | Baseline to 30 Days after last dose | Safety will be assessed by physical exam, vital signs, monitoring of adverse events, changes in ECG, and other clinical laboratory values |
| Secondary | Anti-tumor activity based on tumor assessments (RECIST 1.1) and dates of progression | Baseline to 30 Days after last dose | |
| Secondary | PK of onapristone, mono-demethylated onapristone and other metabolites in plasma and urine | Baseline to 30 Days after last dose | AUC, Cmax, Tmax, t1/2 |
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.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30304013 | DERIVED |
Source PubMed
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/NCT02052128
GET https://conductscience.org/api/trials/v1/NCT02052128/registered