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Once-daily Oral Seviteronel in Patients With Castration-Resistant Prostate Cancer Progressing on Enzalutamide or Abiraterone. | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Once-daily Oral Seviteronel in Patients With Castration-Resistant Prostate Cancer Progressing on Enzalutamide or Abiraterone.

A Phase 2 Open-label Study to Evaluate the Efficacy and Safety of Seviteronel in Subjects With Castration-Resistant Prostate Cancer Progressing on Enzalutamide or Abiraterone

NCT02445976•Innocrin Pharmaceutical

View on ClinicalTrials.gov

Summary

The goal of this clinical study is to determine the efficacy and safety of Seviteronel, a lyase-selective inhibitor of CYP17 and an androgen receptor antagonist, in patients with castration-resistant prostate cancer (CRPC) who have been previously treated with enzalutamide and/or abiraterone.

Detailed Description

This is a phase 2 clinical trial of Seviteronel (an oral, potent and lyase-selective CYP17 inhibitor) in men with castration-resistant prostate cancer (CRPC) progressing on enzalutamide or abiraterone. Approximately 197 subjects will be used to assess treatment efficacy. The study will be conducted in two different clinical cohorts separated by prior exposure to enzalutamide or abiraterone, or prior exposure to enzalutamide and abiraterone.

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•1. Subjects must be ≥18 years of age.
•2. Subjects or their legal representatives must be able to provide written informed consent.
•3. Subjects must have documented histological or cytological evidence of adenocarcinoma of the prostate.
•4. Subjects must have an ECOG Performance Score of 0-1.
•5. Subjects must have undergone orchiectomy, or have ongoing LHRH analogue therapy prior to drug initiation. Subjects on LHRH analogues must remain on these agents for the duration of the study.
•6. Subjects must have castrate levels of testosterone (≤50 ng/dl \[1.7 nmol/L\]) and have progressive disease at Screening defined as PSA rise determined by a minimum of 2 rising PSA values ≥1 week between each assessment. The PSA value at the Screening visit must be ≥2ng/mL with or without:
•* Soft tissue disease progression defined by RECIST 1.1 at Screening or ≤ 28 days of C1D1. Measurable disease is not required for entry. Lymph nodes ≥ 1.5cm (short axis) are considered measurable disease (PCWG3)
•* Bone disease progression defined by ≥2 new lesions on bone scan at Screening, or ≤28 days of C1D1
•7. Subjects must have received abiraterone and/or enzalutamide. Subject must have received either abiraterone or enzalutamide for ≥12 weeks. Other second generation CYP17 inhibitors/androgen receptor antagonists including but not limited to TAK-700 (orteronel), TOK-001 (galeterone) may have been taken in place of abiraterone and ARN-509 (apalutamide) may have been taken in place of enzalutamide.
•8. Subjects must have adequate hematopoietic function as evidenced by:
+16 more criteria

Exclusion Criteria

•1. Subjects who have completed sipuleucel-T (Provenge ®) treatment within 28 days of study drug initiation.
•2. Subjects on 5-alpha reductase inhibitors such as finasteride (PROSCAR®, PROPECIA®), or dutasteride (AVODART®) within 28 days of study drug initiation.
•3. Subjects who received any investigational agent ≤28 days of study drug initiation.
•4. Subjects who received palliative radiotherapy ≤2 weeks of study drug initiation.
•5. Subjects with symptomatic CNS metastases.
•6. Subjects with a history of another invasive malignancy ≤3 years of study drug initiation.
•7. Subjects with a QTcF interval of \>470 msec; if the Screening ECG QTcF interval is \>470 msec, it may be repeated, and if repeat \<470 msec, the subject may be enrolled.
•8. Subject with clinically significant cardiac arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, torsades de pointes, second degree or third degree atrioventricular heart block without a permanent pacemaker in place)
•9. Subject that started a bone modifying agent (e.g. bisphosphonates, denosumab) ≤ 28 days of study drug initiation (note: ongoing bone modifying agents administered \> 28 days are allowed).
•10. Subject with any medical condition that could preclude subject participation in the study, pose an undue medical hazard, or which could interfere with study results.
+5 more criteria

Locations (21)

University of Alabama

Birmingham, Alabama, United States

Mayo Clinic

Scottsdale, Arizona, United States

University of California at Los Angeles

Los Angeles, California, United States

Yale University

New Haven, Connecticut, United States

Mayo Clinic - Jacksonville

Jacksonville, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

Tulane University

New Orleans, Louisiana, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

Key Dates

Start Date

May 1, 2015

Primary Completion Date

December 1, 2018

Completion Date

January 1, 2019

Last Updated

February 1, 2019

Enrollment

197

ESTIMATED participants

Conditions

Prostate Cancer

Interventions

Seviteronel: given orally once daily in 28-day cycles

DRUG

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

NCT06842498

Metastatic Castration-Resistant Prostate Cancer

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 1, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Once-daily Oral Seviteronel in Patients With Castration-Resistant Prostate Cancer Progressing on Enzalutamide or Abiraterone.

Inclusion Criteria

Exclusion Criteria

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

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