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A Safety and Pharmacokinetics Study of Niraparib Plus Apalutamide in Men With Metastatic Castration-Resistant Prostate Cancer

2016-10-06 00:38:22 | BioPortfolio

Summary

The purpose of this study is to assess the safety and pharmacokinetics of niraparib when administered in combination with apalutamide in men with metastatic castration resistant prostate cancer (mCRPC) who may or may not have deoxyribonucleic acid (DNA)-repair anomalies.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Prostatic Neoplasms

Intervention

Niraparib, Apalutamide

Location

West Hollywood
California
United States

Status

Not yet recruiting

Source

Janssen Research & Development, LLC

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-10-06T00:38:22-0400

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A Study of Niraparib Combination Therapies for the Treatment of Metastatic Castration-Resistant Prostate Cancer

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An Efficacy and Safety Study of Niraparib in Men With Metastatic Castration-Resistant Prostate Cancer and DNA-Repair Anomalies

The purpose of this study is to assess the efficacy, safety, and pharmacokinetics of niraparib in men with metastatic castration resistant prostate cancer (mCRPC) and deoxyribonucleic acid...

Crossover Study to Assess the Relative Bioavailability of Niraparib Tablet Compared to Niraparib Capsule

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A Trial of Niraparib in BAP1 and Other DNA Double-Strand Break Repair Deficient Neoplasms (UF-STO-ETI-001)

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PubMed Articles [582 Associated PubMed Articles listed on BioPortfolio]

Validation of an LC-ESI-MS/MS method for the determination of apalutamide, a novel non-steroidal anti-androgen in mice plasma and its application to a pharmacokinetic study in mice.

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Apalutamide: First Global Approval.

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Medical and Biotech [MESH] Definitions

Tissue ablation of the PROSTATE performed by ultrasound from a transducer placed in the RECTUM. The procedure is used to treat prostate cancer (PROSTATIC NEOPLASMS) and benign prostatic hypertrophy (PROSTATIC HYPERPLASIA).

Tumors or cancer of the PROSTATE.

A premalignant change arising in the prostatic epithelium, regarded as the most important and most likely precursor of prostatic adenocarcinoma. The neoplasia takes the form of an intra-acinar or ductal proliferation of secretory cells with unequivocal nuclear anaplasia, which corresponds to nuclear grade 2 and 3 invasive prostate cancer.

A nitrogen mustard linked to estradiol, usually as phosphate; used to treat prostatic neoplasms; also has radiation protective properties.

Tumors or cancer of the PROSTATE which can grow in the presence of low or residual amount of androgen hormones such as TESTOSTERONE.

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