Trial · NCT04207255
Addition of Opaganib to Androgen Antagonists in Patients With mCRPC
NCT04207255, Phase 2, Completed, Medical University of South Carolina; results first posted 2024-09-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Addition of Opaganib to Androgen Antagonists in Patients With mCRPC. Trials, record NCT04207255. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04207255
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Addition of Opaganib to Androgen Antagonists in Patients With mCRPC
- NCT number
- NCT04207255
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 69 participants, actual
- Lead sponsor
- Medical University of South Carolina
- Conditions
- Prostate Cancer
- Interventions
- Opaganib, Abiraterone, Enzalutamide, Opaganib
- First posted
- 2019-12-20
- Last updated
- 2024-09-25
- Results first posted
- 2024-09-25
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Disease Control Status | 113 days | Stable disease or better according to Prostate Cancer Working Group 3 (PCWG3) criteria after four cycles of treatment |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Disease Control Status | 113 days | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Disease Control Status | Cohort 2: Opaganib With Abiraterone | 4 | Participants | ||
| Disease Control Status | Cohort 3: Opaganib With Enzalutamide | 3 | Participants | ||
| Disease Control Status | Cohort 1a: Opaganib With Abiraterone | 0 | Participants | ||
| Disease Control Status | Cohort 1b: Opaganib With Enzalutamide | 0 | Participants |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 2: Opaganib With Abiraterone | 27 | |
| Overall Study | STARTED | Cohort 3: Opaganib With Enzalutamide | 36 | |
| Overall Study | STARTED | Cohort 1a: Opaganib With Abiraterone | 3 | |
| Overall Study | STARTED | Cohort 1b: Opaganib With Enzalutamide | 3 | |
| Overall Study | COMPLETED | Cohort 2: Opaganib With Abiraterone | 27 | |
| Overall Study | COMPLETED | Cohort 3: Opaganib With Enzalutamide | 36 | |
| Overall Study | COMPLETED | Cohort 1a: Opaganib With Abiraterone | 3 | |
| Overall Study | COMPLETED | Cohort 1b: Opaganib With Enzalutamide | 3 | |
| Overall Study | NOT COMPLETED | Cohort 2: Opaganib With Abiraterone | 0 | |
| Overall Study | NOT COMPLETED | Cohort 3: Opaganib With Enzalutamide | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events396
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | COVID-19 | Respiratory, thoracic and mediastinal disorders | Cohort 2: Opaganib With Abiraterone | 1 | 27 | 1 |
| other | COVID-19 | Respiratory, thoracic and mediastinal disorders | Cohort 3: Opaganib With Enzalutamide | 1 | 36 | 1 |
| other | COVID-19 | Respiratory, thoracic and mediastinal disorders | Cohort 1a: Opaganib With Abiraterone | 0 | 3 | 0 |
| other | COVID-19 | Respiratory, thoracic and mediastinal disorders | Cohort 1b: Opaganib With Enzalutamide | 0 | 3 | 0 |
| other | Deep vein thrombosis | Vascular disorders | Cohort 2: Opaganib With Abiraterone | 1 | 27 | 1 |
| other | Deep vein thrombosis | Vascular disorders | Cohort 3: Opaganib With Enzalutamide | 0 | 36 | 0 |
| other | Deep vein thrombosis | Vascular disorders | Cohort 1a: Opaganib With Abiraterone | 0 | 3 | 0 |
| other | Deep vein thrombosis | Vascular disorders | Cohort 1b: Opaganib With Enzalutamide | 0 | 3 | 0 |
| other | Blood bilirubin increased | Investigations | Cohort 2: Opaganib With Abiraterone | 0 | 27 | 0 |
| other | Blood bilirubin increased | Investigations | Cohort 3: Opaganib With Enzalutamide | 0 | 36 | 0 |
1 to 10 of 396Source ClinicalTrials.gov
See all 396 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 2: Opaganib With Abiraterone | 0 | 27 |
| Total, all-cause mortality | Cohort 3: Opaganib With Enzalutamide | 1 | 36 |
| Total, all-cause mortality | Cohort 1a: Opaganib With Abiraterone | 0 | 3 |
| Total, all-cause mortality | Cohort 1b: Opaganib With Enzalutamide | 0 | 3 |
| Total, other adverse events | Cohort 2: Opaganib With Abiraterone | 27 | 27 |
| Total, other adverse events | Cohort 3: Opaganib With Enzalutamide | 36 | 36 |
| Total, other adverse events | Cohort 1a: Opaganib With Abiraterone | 3 | 3 |
| Total, other adverse events | Cohort 1b: Opaganib With Enzalutamide | 3 | 3 |
| Total, serious adverse events | Cohort 2: Opaganib With Abiraterone | 3 | 27 |
| Total, serious adverse events | Cohort 3: Opaganib With Enzalutamide | 11 | 36 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41981710 | DERIVED |
Source PubMed
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P01CA203628 | Development of Novel Cancer Therapeutics by Targeting Sphingolipid Signaling | OGRETMEN, BESIM | MEDICAL UNIVERSITY OF SOUTH CAROLINA | NATIONAL CANCER INSTITUTE | 2016 to 2021 |
Source NIH RePORTER
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/NCT04207255
GET https://conductscience.org/api/trials/v1/NCT04207255/events?page=2