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

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

Sponsors

Lead Sponsor: Aragon Pharmaceuticals, Inc.

Source Aragon Pharmaceuticals, Inc.
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).

Overall Status Available
Study Type Expanded Access
Condition
Intervention

Intervention Type: Drug

Intervention Name: Apalutamide

Description: Participants will receive apalutamide 240 mg orally once daily.

Other Name: JNJ-56021927

Intervention Type: Drug

Intervention Name: ADT (Standard of Care)

Description: Participants who did not undergo surgical castration, should receive and remain on a stable regimen of ADT according to local standard of care.

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)

Gender:

Male

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Aragon Pharmaceuticals, Inc. Clinical Trial Study Director Aragon Pharmaceuticals, Inc.
Overall Contact

Last Name: Study Contact

Phone: 844-434-4210

Email: [email protected]

Location
Facility: Status:
Ynova Pesquisa Clinica | Florianopolis, 88020-210, Brazil Available
Instituto COI de Pesquisa, Educacao e Gestao | Rio de Janeiro, 22793-080, Brazil Available
Instituto Etica - Amo | Salvador, Brazil Available
ICESP - INSTITUTO DO CANCER DO ESTADO DE SAO PAULO OCTAVIO FRIAS de OLIVEIRA | Sao Paulo, 01246-000, Brazil Available
Fundacao Antonio Prudente | Sao Paulo, 01509900, Brazil Available
IBCC Instituto Brasileiro de Controle do Cancer | Sao Paulo, 03102-002, Brazil Available
Clinica Universitaria Colombia | Bogota, 0000, Colombia Available
Fundacion Santa Fe de Bogota | Bogotá, 110111, Colombia Available
Hospital Universitario San Ignacio | Bogotá, 110231, Colombia Available
Instituto Nacional de Cancerologia | Bogotá, 111511, Colombia Available
Hospital Pablo Tobon Uribe | Medellin, 050034, Colombia Available
Centro Medco ABC Observatorio | Ciudad de México, 01120, Mexico Available
Inst. Nal. de Ciencias Med. Y Nutricion Salvador Zubiran | Mexico City, 14000, Mexico Available
Centro Medico Nacional 20 de Noviembre ISSSTE | Mexico City, 3229, Mexico Available
Instituto Nacional de Cancerologia | Mexico, 14080, Mexico Available
Hospital Central Sur de Alta Especialidad Pemex Picacho | Mexico, 14140, Mexico Available
i Can Oncology Center | Monterrey, 64710, Mexico Available
Oncología Integral Satelite | Naucalpan, 53100, Mexico Available
Centro Oncologico Estatal ISSEMYM | Toluca, 50180, Mexico Available
Farmaco Oncología especializada S.A. de C.V | Zapopan, 45050, Mexico Available
Location Countries

Brazil

Colombia

Mexico

Verification Date

2021-09-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse

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