Clinical trial NCT03523338: An Expanded Access Protocol for Apalutamide Treatment of Participants With Non-Metastatic Castration-Resistant Prostate Cancer
Official title: An Open-Label Expanded Access Protocol for Apalutamide Treatment of Subjects With Non Metastatic Castration-Resistant Prostate Cancer
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Prostatic Neoplasms
Lead sponsor: Aragon Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2018-05-14
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

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).


Eligibility criteria: 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)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Florianopolis
country: Brazil
facility: Ynova Pesquisa Clinica
city: Rio de Janeiro
country: Brazil
facility: Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
city: Salvador
country: Brazil
facility: Ensino e Terapia de Inovacao Clinica AMO - Etica
city: Sao Paulo
country: Brazil
facility: Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo
city: Sao Paulo
country: Brazil
facility: Fundacao Antonio Prudente - A.C. Camargo Cancer Center
city: São Paulo
country: Brazil
facility: Núcleo de Pesquisa São Camilo
city: Medellin
country: Colombia
facility: Hospital Pablo Tobon Uribe
city: Mexico
country: Mexico
facility: Instituto Nacional de Cancerologia
city: Monterrey
country: Mexico
facility: i Can Oncology Center
city: Naucalpan
country: Mexico
facility: Oncologia Integral Satelite
city: Toluca
country: Mexico
facility: Centro Oncologico Estatal ISSEMYM
city: Zapopan
country: Mexico
facility: Farmaco Oncología especializada S.A. de C.V
Study officials:
affiliation: Aragon Pharmaceuticals, Inc.
name: Aragon Pharmaceuticals, Inc. Clinical Trial
role: STUDY_DIRECTOR
References: