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

Prostatic Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: No longer available

Administrative data

• NCT number: NCT03523338
• Other study ID #: CR108434
• Secondary ID: 2017-004203-4156
• Status: No longer available

Study information

• Verified date: December 2023
• Source: Aragon Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Expanded Access

Clinical Trial 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).

Recruitment information / eligibility

• Status: No longer available
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Prostatic Neoplasms

Intervention

Drug:
• Apalutamide
Participants will receive apalutamide 240 mg orally once daily.
• ADT (Standard of Care)
Participants who did not undergo surgical castration, should receive and remain on a stable regimen of ADT according to local standard of care.

Locations

Country	Name	City	State
Brazil	Ynova Pesquisa Clinica	Florianopolis
Brazil	Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)	Rio de Janeiro
Brazil	Ensino e Terapia de Inovacao Clinica AMO - Etica	Salvador
Brazil	Fundacao Antonio Prudente - A.C. Camargo Cancer Center	Sao Paulo
Brazil	Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo	Sao Paulo
Brazil	Núcleo de Pesquisa São Camilo	São Paulo
Colombia	Hospital Pablo Tobon Uribe	Medellin
Mexico	Instituto Nacional de Cancerologia	Mexico
Mexico	i Can Oncology Center	Monterrey
Mexico	Oncologia Integral Satelite	Naucalpan
Mexico	Centro Oncologico Estatal ISSEMYM	Toluca
Mexico	Farmaco Oncología especializada S.A. de C.V	Zapopan

Sponsors (1)

Lead Sponsor	Collaborator
Aragon Pharmaceuticals, Inc.

Countries where clinical trial is conducted

Brazil,  Colombia,  Mexico,