Once-daily Oral Seviteronel in Patients With Castration-Resistant Prostate Cancer Progressing on Enzalutamide or Abiraterone.
NCT ID: NCT02445976
Last Updated: 2019-02-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
197 participants
INTERVENTIONAL
2015-05-31
2019-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study to Evaluate Oral VT-464 in Patients With Castration-Resistant Prostate Cancer
NCT02012920
Prostate Cancer Intensive, Non-Cross Reactive Therapy (PRINT) for Castration Resistant Prostate Cancer (CRPC)
NCT02903160
A Study to Learn About the Study Medicines Called Enzalutamide and Abiraterone in People With Metastatic Castration-resistant Prostate Cancer
NCT05968599
A Study of Niraparib Combination Therapies for the Treatment of Metastatic Castration-Resistant Prostate Cancer
NCT03431350
Selinexor in Treating Patients With Abiraterone Acetate and/or Enzalutamide Refractory Metastatic Castration-Resistant Prostate Cancer
NCT02215161
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Prior Abiraterone or Enzalutamide
Seviteronel: given orally once daily in 28-day cycles
Seviteronel: given orally once daily in 28-day cycles
Oral Seviteronel given once daily, in continuous 28-day cycles at the recommended Phase 2 dose
Prior Abiraterone and Enzalutamide
Seviteronel: given orally once daily in 28-day cycles
Seviteronel: given orally once daily in 28-day cycles
Oral Seviteronel given once daily, in continuous 28-day cycles at the recommended Phase 2 dose
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Seviteronel: given orally once daily in 28-day cycles
Oral Seviteronel given once daily, in continuous 28-day cycles at the recommended Phase 2 dose
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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:
* WBC ≥3,000/µl
* ANC ≥1,500/µl
* Platelet count ≥100,000/µl
* HGB ≥10 g/dl and not transfusion dependent
9. Subjects must have adequate liver function, including all of the following:
* Total serum bilirubin ≤2.0 x ULN unless the subject has documented Gilbert syndrome;
* Aspartate and alanine aminotransferase (AST \& ALT) ≤3.0 x ULN or ≤5.0 x ULN if subject has liver metastasis;
* Alkaline phosphatase ≤2.0 x ULN or ≤5 x ULN in case of bone metastasis and/or hepatic metastasis
10. Subjects must have adequate renal function as evidenced by a serum creatinine of \<2.0 mg/dl.
11. Subjects must have potassium (K+) \>3.5 mEq/l.
12. Subject and his female partner who is of childbearing potential must use 2 acceptable methods of birth control (one of which must include a condom as a barrier method of contraception) starting a Screening and continuing throughout the study period and for 3 months after final study drug administration • Two acceptable forms of birth control include:
1\. Condom (barrier method of contraception), and 2. One of the following:
1. Oral, injected or implanted hormonal contraception
2. Placement of an intrauterine device (IUD) or intrauterine system (ISU)
3. Additional barrier methods of contraception: Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.
4. Vasectomy or surgical castration ≥ 6 months prior to Screening. 13. Subjects able to swallow study medication 14. Subjects able to comply with study requirements
Exclusion Criteria
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.
11. Subject with Class III or IV Congestive Heart Failure as defined by the New York Heart Association (NYHA) functional classification system within the previous 6 months.
12. Subject with a history of loss of consciousness or transient ischemic attack ≤ 12 months of study drug initiation.
13. Subject with known active HIV, Hepatitis B, or Hepatitis C infections.
14. Subject with known or suspected hypersensitivity to seviteronel, or any components of the formulation
15. Subject with any other condition which in the opinion of the investigator would preclude participation in the study.
18 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Prostate Cancer Foundation
OTHER
Prostate Cancer Clinical Trials Consortium
OTHER
Innocrin Pharmaceutical
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
University of Minnesota
Minneapolis, Minnesota, United States
Washington University
St Louis, Missouri, United States
GU Research Network
Omaha, Nebraska, United States
New Mexico Cancer Care Alliance
Albuquerque, New Mexico, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States
University of Virginia
Charlottesville, Virginia, United States
Virginia Oncology Associates
Hampton, Virginia, United States
University of Washington
Seattle, Washington, United States
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
VMT-VT-464-CL-003
Identifier Type: OTHER
Identifier Source: secondary_id
INO-VT-464-CL-003
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.