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

Sponsor
Aragon Pharmaceuticals, Inc. (Industry)
Overall Status
Available
CT.gov ID
NCT03523338
Collaborator
(none)
20
Locations

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Expanded Access
Official Title:
An Open-Label Expanded Access Protocol for Apalutamide Treatment of Subjects With Non Metastatic Castration-Resistant Prostate Cancer

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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
    1. 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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ynova Pesquisa Clinica Florianopolis Brazil 88020-210
    2 Instituto COI de Pesquisa, Educacao e Gestao Rio de Janeiro Brazil 22793-080
    3 Instituto Etica - Amo Salvador Brazil
    4 ICESP - INSTITUTO DO CANCER DO ESTADO DE SAO PAULO OCTAVIO FRIAS de OLIVEIRA Sao Paulo Brazil 01246-000
    5 Fundacao Antonio Prudente Sao Paulo Brazil 01509900
    6 Núcleo de Pesquisa São Camilo São Paulo Brazil 04014-002
    7 Clinica Universitaria Colombia Bogota Colombia 0000
    8 Fundacion Santa Fe de Bogota Bogotá Colombia 110111
    9 Hospital Universitario San Ignacio Bogotá Colombia 110231
    10 Instituto Nacional de Cancerologia Bogotá Colombia 111511
    11 Hospital Pablo Tobon Uribe Medellin Colombia 050034
    12 Centro Medco ABC Observatorio Ciudad de México Mexico 01120
    13 Inst. Nal. de Ciencias Med. Y Nutricion Salvador Zubiran Mexico City Mexico 14000
    14 Centro Medico Nacional 20 de Noviembre ISSSTE Mexico City Mexico 3229
    15 Instituto Nacional de Cancerologia Mexico Mexico 14080
    16 Hospital Central Sur de Alta Especialidad Pemex Picacho Mexico Mexico 14140
    17 i Can Oncology Center Monterrey Mexico 64710
    18 Oncologia Integral Satelite Naucalpan Mexico 53100
    19 Centro Oncologico Estatal ISSEMYM Toluca Mexico 50180
    20 Farmaco Oncología especializada S.A. de C.V Zapopan Mexico 45050

    Sponsors and Collaborators

    • Aragon Pharmaceuticals, Inc.

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Aragon Pharmaceuticals, Inc.
    ClinicalTrials.gov Identifier:
    NCT03523338
    Other Study ID Numbers:
    • CR108434
    • 2017-004203-41
    • 56021927PCR3010
    First Posted:
    May 14, 2018
    Last Update Posted:
    Aug 3, 2022
    Last Verified:
    Aug 1, 2022
    Additional relevant MeSH terms:
    Prostatic Neoplasms

    Study Results

    No Results Posted as of Aug 3, 2022