Trial · NCT02580448
CYP17 Lyase and Androgen Receptor Inhibitor Treatment With Seviteronel Trial (INO-VT-464-006; NCT02580448)
NCT02580448, Phase 1, Phase 2, Completed, Innocrin Pharmaceutical
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. CYP17 Lyase and Androgen Receptor Inhibitor Treatment With Seviteronel Trial (INO-VT-464-006; NCT02580448). Trials, record NCT02580448. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02580448
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- CYP17 Lyase and Androgen Receptor Inhibitor Treatment With Seviteronel Trial (INO-VT-464-006; NCT02580448)
- NCT number
- NCT02580448
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 175 participants, estimated
- Lead sponsor
- Innocrin Pharmaceutical
- Conditions
- Cancer of the Breast, Breast Cancer, Advanced Breast Cancer, Metastatic Breast Cancer, Male Breast Cancer, Triple Negative Breast Cancer, ER+ Breast Cancer
- Interventions
- Seviteronel
- First posted
- 2015-10-20
- Last updated
- 2019-02-01
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Estimate efficacy of seviteronel as measured by clinical benefit rate at 16 weeks (CBR16) for female subjects with TNBC. | Duration of Study | |
| Primary | Estimate efficacy of seviteronel as measured by clinical benefit rate at 24 weeks (CBR24) for female subjects with ER+ BC. | Duration of Study | |
| Primary | Estimate efficacy of seviteronel as measured by CBR16 for all male BC subjects. | Duration of Study | |
| Secondary | Describe the pharmacokinetics of seviteronel | At least monthly over the first eight 28-day cycles | Area under the curve concentration verses time curve and Peak Plasma Concentration |
| Secondary | Estimate efficacy of seviteronel as measured by the overall response rate (ORR) based on RECIST 1.1 | At least monthly over the first eight 28-day cycles | |
| Secondary | Estimate efficacy of seviteronel as measured by progression-free survival (PFS) | At least monthly over the first eight 28-day cycles | |
| Secondary | Describe the safety profile of seviteronel | Duration of the study | |
| Secondary | Compare the safety profile of seviteronel with or without concurrent glucocorticoid administration | Duration of the study | |
| Secondary | Compare the CBR16 with or without concurrent glucocorticoid administration for female subjects with TNBC | Duration of the study |
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/NCT02580448
GET https://conductscience.org/api/trials/v1/NCT02580448/registered