A Study to Monitor the Safety of Enzalutamide in Patients With Progressive Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy

NCT02124668 | Completed Phase 2

• 1 other identifier: 9785-CL-0122
• Study Type: interventional
• Target: 30
• Locations: 2 countries
• Sites: 4

Brief Summary

The purpose of this study is to monitor the safety of enzalutamide in patients with progressive castration-resistant prostate cancer previously treated with docetaxel-based chemotherapy.

Conditions

Castration-Resistant Prostate Cancer; Prostate Cancer

Keywords

Xtandi; MDV3100; Progressive Castration-Resistant Prostate Cancer; Enzalutamide

Outcome Measures

Primary Outcomes (1)

• Safety profile of enzalutamide assessed by adverse events (AEs), serious AEs (SAEs), vital signs, electrocardiograms (ECGs) and laboratory measurements

  Up to 30 days after the last dose of enzalutamide or prior to the initiation of another anticancer therapy, whichever comes first (up to 18 months)

Study Arms (1)

Enzalutamide

EXPERIMENTAL

Enzalutamide

Drug: Enzalutamide

Interventions

Enzalutamide DRUG

oral

Also known as: Xtandi, MDV3100

Enzalutamide

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has histologically or cytologically confirmed adenocarcinoma of the prostate
• Subject has ongoing androgen deprivation therapy with a gonadotropin-releasing hormone (GnRH) analogue (agonist or antagonist) and plans to maintain throughout the study period or has had a prior orchiectomy (i.e., surgical or medical castration)
• Subject has had at least one prior chemotherapy regimen for metastatic castration-resistant prostate cancer with at least one regimen containing docetaxel
• Subject has progressive disease and indication for change of antineoplastic regimen
• Subject has no known or suspected brain metastasis
• Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
• Subject is able to swallow the study drug and comply with study requirements
• There is no comparable or satisfactory alternative therapy to treat the subject's disease
• Subject agrees not to participate in another interventional study while on treatment

You may not qualify if:

• Subject has severe concurrent disease, infection, or co-morbidity that would make the subject inappropriate for enrollment
• Subject's absolute neutrophil count is \< 1000/μL, or platelet count \< 100,000/μL, or hemoglobin \< 6.2 mmol/L (or \< 10 g/dL)
• Subject's total bilirubin is ≥ 1.5 x upper limit of normal (ULN) (except for subjects with documented Gilbert's disease) or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) is ≥ 2.5x ULN
• Subject's estimated creatinine clearance is less than 30 mL/min by the Cockcroft and Gault formula
• Subject has albumin ≤ 30 g/L (or ≤ 3.0 g/dL)
• Subject has received anti-androgen therapy (e.g. bicalutamide), chemotherapy, or biologic therapy for prostate cancer (other than bone targeted agents such as bisphosphonates or denosumab, gonadotropin-releasing hormone (GnRH) analogue therapy, or glucocorticoids which are allowed) within 4 weeks of Day 1
• Subject has had prior use of abiraterone
• Subject has prior use, or participation in a clinical trial, of an investigational agent that blocks androgen synthesis (e.g. TAK-700) or targets the androgen receptor (e.g. ARN-509, ODM-201)
• Subject has:
• A history of seizure, including any febrile seizure or any condition that may predispose to seizure including, but not limited to underlying brain injury, stroke, primary brain tumors, brain metastases,
• A history of loss of consciousness or transient ischemic attack within 12 months of Screening
• Subject has clinical signs suggestive of high or imminent risks for pathological fracture, spinal cord compression and/or cauda equina syndrome
• Subject has a significant cardiovascular disease
• Subject has received investigational therapy within 28 days or 5 half lives, whichever is longer, prior to Screening
• Subject has undergone major surgery within 4 weeks prior to Screening

Sponsors & Collaborators

• Astellas Pharma Europe B.V.: lead
• Medivation LLC, a wholly owned subsidiary of Pfizer Inc.: collaborator

Study Sites (4)

Site GE99503

Tbilisi, 0144, Georgia

Location

Site GE99502

Tbilisi, 0159, Georgia

Location

Site RU70002

Moscow, 115478, Russia

Location

Site RU70003

Moscow, 125284, Russia

Location

Related Links

• Link to results on the Astellas Clinical Study Results website

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

enzalutamide

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Medical Director

  Astellas Pharma Europe B.V.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2014
• First Posted: April 28, 2014
• Study Start: September 23, 2014
• Primary Completion: May 25, 2017
• Study Completion: May 25, 2017
• Last Updated: November 21, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

GE (2); RU (2)