Trial · NCT02049190
Phase 1-2 Study of Onapristone in Patients With Advanced Castration-resistant Prostate Cancer
NCT02049190, 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 Advanced Castration-resistant Prostate Cancer. Trials, record NCT02049190. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02049190
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 Advanced Castration-resistant Prostate Cancer
- NCT number
- NCT02049190
- Status
- Unknown
- Phases
- Phase 1, Phase 2
- Enrollment
- 75 participants, estimated
- Lead sponsor
- Arno Therapeutics
- Conditions
- Prostate Cancer, Metastatic Prostate Cancer, Androgen-independent Prostate Cancer, Recurrent Prostate Cancer
- Interventions
- onapristone, abiraterone
- First posted
- 2014-01-30
- Last updated
- 2015-06-24
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Dose limiting toxicities related to onapristone or the combination of onapristone and abiraterone utilizing a day 57 safety cut off and based on CTCAE v4 | Baseline to 57 days post-first dose | |
| Primary | Response to onapristone or the combination of onapristone and abiraterone | Baseline to 30 Days after last dose | * Objective partial or complete response by RECIST 1.1, confirmed on a second CT scan at least 4 weeks apart and / or * PSA decline of ≥ 50% (according to the PCWG2). |
| Secondary | Safety and tolerability of extended-release onapristone tablets BID | Baseline to 30 Days after last dose | Safety will be assessed by physical exam, vital signs, monitoring of adverse events, changes in ECG, and changes in PSA and other clinical laboratory values. |
| Secondary | PK of onapristone, mono-demethylated onapristone and other metabolites in plasma and urine | Baseline to 30 Days after last dose |
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/NCT02049190
GET https://conductscience.org/api/trials/v1/NCT02049190/registered