Breast Cancer Clinical Trial
Official title:
A Phase 1/2 Open-Label Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Seviteronel in Subjects With Advanced Breast Cancer
The goal of this clinical study is to determine the safety, pharmacokinetics, pharmacodynamics and efficacy and activity of seviteronel, a lyase-selective inhibitor of CYP17, in patients with advanced breast cancer.
This is an open-label, Phase 1/2 study of seviteronel in subjects with TNBC or ER +/HER2
normal unresectable locally advanced breast cancer. Only women will be enrolled in Phase 1
and both men and women enrolled into their respective cohorts in Phase 2. There will be a
dose confirmation Phase 1 portion of the study to establish the recommended Phase 2 dose
(RP2D) for women with breast cancer using a non-stratified, combined cohort of women with
TNBC or ER+ BC. Cohort expansion will occur in Phase 2 at the RP2D confirmed/established in
Phase 1 using separate TNBC and ER+ cohorts. The Phase 2 portion of the study is divided into
three parallel cohorts:
Cohort 1: Female TNBC Subjects Cohort 2: Female ER+ Subjects Cohort 3: Male ER+ BC or TNBC
Subjects
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
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| Terminated |
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Phase 2 | |
| Completed |
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N/A | |
| Completed |
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|
N/A | |
| Recruiting |
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|
N/A | |
| Terminated |
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|
Phase 2 | |
| Active, not recruiting |
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|
||
| Withdrawn |
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N/A | |
| Completed |
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||
| Recruiting |
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|
Phase 2 | |
| Active, not recruiting |
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|
Phase 1 | |
| Recruiting |
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|
Phase 1 | |
| Completed |
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N/A | |
| Recruiting |
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Phase 3 | |
| Terminated |
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N/A | |
| Enrolling by invitation |
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||
| Completed |
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||
| Recruiting |
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Phase 1/Phase 2 | |
| Recruiting |
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|
N/A | |
| Recruiting |
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|
N/A |