An Expanded Access Protocol for Apalutamide Treatment of Participants With Non-Metastatic Castration-Resistant Prostate Cancer

December 7, 2023 updated by: Aragon Pharmaceuticals, Inc.

An Open-Label Expanded Access Protocol for Apalutamide Treatment of Subjects With Non Metastatic Castration-Resistant Prostate Cancer

The purpose of this study is to collect additional safety data until apalutamide is commercially available for participants with non-metastatic castrate-resistant prostate cancer (NM-CRPC).

Study Overview

Status

No longer available

Conditions

Intervention / Treatment

Study Type

Expanded Access

Expanded Access Type

  • Intermediate-size Population

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Florianopolis, Brazil, 88020-210
        • YNOVA Pesquisa Clinica
      • Rio de Janeiro, Brazil, 22775-001
        • Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
      • Salvador, Brazil, 41950-640
        • Ensino E Terapia de Inovacao Clinica Amo - Etica
      • Sao Paulo, Brazil, 01246-000
        • Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo
      • Sao Paulo, Brazil, 01509900
        • Fundacao Antonio Prudente - A.C. Camargo Cancer Center
      • São Paulo, Brazil, 04014-002
        • Núcleo de Pesquisa São Camilo
  • Colombia
      • Medellin, Colombia, 050034
        • Hospital Pablo Tobon Uribe
  • Mexico
      • Mexico, Mexico, 14080
        • Instituto Nacional de Cancerologia
      • Monterrey, Mexico, 64710
        • i Can Oncology Center
      • Naucalpan, Mexico, 53100
        • Oncologia Integral Satelite
      • Toluca, Mexico, 50180
        • Centro Oncologico Estatal ISSEMYM
      • Zapopan, Mexico, 45050
        • Farmaco Oncología especializada S.A. de C.V

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participants with confirmed prostate cancer, with evidence of castration resistance, with a rising prostate-specific antigen (PSA) while on androgen deprivation therapy (ADT), and for whom the treating physician believes additional therapy is indicated in the non-metastatic castrate-resistant prostate cancer (NM-CRPC) setting

    a) Willingness to continue gonadotropin releasing hormone analog (GnRHa) throughout study if the participant is medically castrated

  • Must sign an informed consent form (ICF) (or the participant's legally acceptable representative must sign) indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study
  • To avoid risk of drug exposure through the ejaculate (even participants with vasectomies), participants must use a condom during sexual activity while on study drug and for 3 months following the last dose of study drug. Donation of sperm is not allowed while on study drug and for 3 months following the last dose of study drug
  • Willingness and ability to comply with prohibitions and restrictions specified in this protocol, scheduled visits, treatment plans, laboratory, and other study procedures, including ability to swallow study drug tablets

Exclusion Criteria:

  • Previously enrolled in another apalutamide study or eligible for enrollment in another ongoing clinical study of apalutamide
  • Enrolled in another interventional clinical study of anti-neoplastic agents
  • Ongoing grade greater than (>) 1 acute toxicity due to prior therapy or surgical procedure
  • Concurrent therapy with medications known to lower the seizure threshold must have been discontinued or substituted at least 4 weeks prior to study entry
  • Current or prior treatment with anti-epileptic medications for the treatment of seizures. History of seizure or condition that may predispose to seizure (including, but not limited to prior cerebrovascular accident, transient ischemic attack, or loss of consciousness within 1 year prior to randomization; brain arteriovenous malformation; or intracranial masses such as a schwannoma or meningioma that is causing edema or mass effect)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aragon Pharmaceuticals, Inc.

Investigators

  • Study Director: Aragon Pharmaceuticals, Inc. Clinical Trial, Aragon Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

May 1, 2018

First Submitted That Met QC Criteria

May 1, 2018

First Posted (Actual)

May 14, 2018

Study Record Updates

Last Update Posted (Estimated)

December 13, 2023

Last Update Submitted That Met QC Criteria

December 7, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR108434
  • 2017-004203-41 (EudraCT Number)
  • 56021927PCR3010 (Other Identifier: Aragon Pharmaceuticals, Inc.)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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