Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Breast Neoplasms

Triple Negative Breast Neoplasms

Breast Neoplasms, Male

Breast Diseases

Skin Diseases

Breast Cancer, Male

Kennedy Disease

All Drugs and Chemicals

Antineoplastic Agents

Androgens

Estrogens

Androgen Receptor Antagonists

Seviteronel

Enzyme Inhibitors

Cytochrome P-450 Enzyme Inhibitors

TNBC Patients - Enrollment is complete in this cohort

Female ER(+) BC Patients - Enrollment is complete in this cohort

Locally advanced or metastatic males with BC

Seviteronel given daily with evening meal in 28 day cycles

Victoria Brown, BS

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

CYP17 Lyase and Androgen Receptor Inhibitor Treatment With Seviteronel Trial (INO-VT-464-006; NCT02580448)

A Phase 1/2 Open-Label Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Seviteronel in Subjects With Advanced Breast Cancer

Area under the curve concentration verses time curve and Peak Plasma Concentration

Innocrin Pharmaceutical

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Seviteronel: given orally once daily in 28 day cycles

The goal of this clinical study is to determine the safety, tolerability, pharmacokinetics and activity of Seviteronel, a lyase-selective inhibitor of CYP17, in patients with castration-resistant prostate cancer (CRPC).

This is a Phase 1/2 study of seviteronel in subjects with castration-resistant prostate cancer (CRPC). Phase 1 was a dose-escalation study enrolling subjects with CRPC that were either "treatment naïve" (not treated with previous abiraterone or enzalutamide), or treated with one or more of the following: abiraterone, enzalutamide, or chemotherapy.

Phase 2 is an open-label, multi-center cohort-expansion study to further determine the efficacy and safety of seviteronel in two CRPC populations with documented rising PSA with or without bone or soft tissue disease progression during treatment with: abiraterone or enzalutamide for ≥ 12 weeks (Group 1) abiraterone and enzalutamide; treatment should be ≥ 12 weeks for at least one agent (Group 2)

A Study to Evaluate Oral VT-464 in Patients With Castration-Resistant Prostate Cancer

A Phase 1/2 Open-Label Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Seviteronel in Subjects With Castration-Resistant Prostate Cancer

Determine if biomarkers are predictors of response to study treatment

Review of subjects with defined PSA value decline of greater than or equal to 50% from study start.

Review of subject disease progression status via CT and measure of median time to progression if progression occurs.

Evaluate RECIST 1.1 response and PCWG3 guidelines for responses.

VT-464: given orally once daily in 28 day cycles. Dosing in the evening before bed 7-days a week with a 2-week dose titration.

VT-464: given orally once daily in 28 day cycles. Dosing in the evening before bed 7-days a week without dose titration.

VT-464: given orally once daily in 28 day cycles. Dosing in the morning 7-days a week with a 2-week dose titration.

VT-464: given orally once daily in 28 day cycles.Dosing in the morning 7-days a week without dose titration.

VT-464: given orally once daily in 28 day cycles.Dosing in the evening before bed 5-days a week without dose titration.

VT-464: given orally once daily in 28 day cycles.Dosing in the morning 5-days a week without dose titration.

VT-464: given orally once daily in 28 day cycles either 5 days or 7 days a week.

VT-464: given orally once daily in 28 day cycles

Joel Eisner

The goal of this clinical study is to determine the safety, tolerability, pharmacokinetics and activity of once-daily (QD) oral dosing of VT-464, a lyase-selective inhibitor of CYP17, in patients with castration-resistant prostate cancer (CRPC).

This is a Phase 1/2 study of VT-464 in chemotherapy-naïve CRPC patients who are treatment-naive or who have failed prior therapy with abiraterone and/or enzalutamide. The study will examine several parallel QD dosing regimens of VT-464 using a traditional modified "3+3" Fibonacci study design. Approximately 3 dose-levels of VT-464 will be examined in each dosing regimen that is fully enrolled.

A Study to Evaluate Once-Daily Oral VT-464 in Patients With Castration-Resistant Prostate Cancer

A Phase 1/2 Open-Label, Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Once-Daily VT-464 in Patients With Castration-Resistant Prostate Cancer

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
CYP17 Lyase and Androgen Receptor Inhibitor Treatment With Seviteronel Trial (INO-VT-464-006; NCT02580448)	NCT02580448	Cancer of the B... Breast Cancer Advanced Breast... Metastatic Brea... Male Breast Can... Triple Negative... ER+ Breast Canc...	Seviteronel	18 Years -	Innocrin Pharmaceutical
A Study to Evaluate Oral VT-464 in Patients With Castration-Resistant Prostate Cancer	NCT02012920	Castration-resi... CRPC	Seviteronel: gi...	18 Years -	Innocrin Pharmaceutical
A Study to Evaluate Once-Daily Oral VT-464 in Patients With Castration-Resistant Prostate Cancer	NCT02361086	Castration-resi... CRPC	VT-464: given o...	18 Years -	Innocrin Pharmaceutical
A Study to Evaluate Once-Daily Oral VT-464 in Patients With Castration-Resistant Prostate Cancer	NCT02361086	Castration-resi... CRPC	VT-464: given o...	18 Years -	Innocrin Pharmaceutical

Spots Global Cancer Trial Database for cyp17

Every month we try and update this database with for cyp17 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for cyp17

Every month we try and update this database with for cyp17 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for cyp17 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.