A Safety Study of JNJ-56021927 in Participants With Metastatic Castration-Resistant Prostate Cancer

2014-09-30 16:38:22 | BioPortfolio


The purpose of this study is to evaluate the safety and tolerability of JNJ-56021927 in Japanese participants with metastatic castration-resistant prostate cancer (mCRPC- prostate cancer that is resistant to medical [for example. hormonal] or surgical treatments).


This is a Phase 1, multicenter, open-label (participants will know the identity of study drug received) study in participants with Metastatic Castration-Resistant Prostate Cancer (mCRPC). The study consists of 4 parts: Screening (28 days before study commences on Day 1), pharmacokinetic week (PK), Continuous daily dosing, Extension and Safety follow-up period. In PK week participants will receive a single oral capsule of JNJ-56021927 at a dose of 240 milligram (mg) on Day 1 and will be monitored for 1 week. After Week 1, in continuous daily dosing period, participants will receive continuous daily therapy at the same dose for 4 weeks (Cycle 1). After Cycle 1 participants, who will not meet the criteria for discontinuation listed such as progressive disease (PD) or unacceptable toxicity, will continue in safety follow-up period and will receive continuous daily therapy at the same dose up to cycle 13. Primarily dose limiting toxicity (DLT) will be evaluated. Participants' safety will be monitored throughout.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Prostatic Neoplasms, Castration-Resistant








Janssen Pharmaceutical K.K.

Results (where available)

View Results


Published on BioPortfolio: 2014-09-30T16:38:22-0400

Clinical Trials [1300 Associated Clinical Trials listed on BioPortfolio]

A Study of JNJ-56021927 (ARN-509) and Abiraterone Acetate in Participants With Metastatic Castration-Resistant Prostate Cancer

The purpose of this study is to investigate potential drug-drug interaction (DDI) between JNJ-56021927 and abiraterone acetate, determine safety of the combination and evaluate in a descri...

A JNJ-56021927 (ARN-509) QT/QTc Study

The purpose of this study is to determine whether daily treatment with JNJ-56021927 (ARN-509) affects the ventricular repolarization in participants with Castration-Resistant Prostate Canc...

A Study to Evaluate the Effect of Multiple Doses of JNJ-56021927 on the Pharmacokinetics of Multiple Cytochrome P450 and Transporter Substrates in Participants With Castration-Resistant Prostate Cancer

The purpose of this study is to evaluate the effects of repeat dosing of JNJ-56021927 on the pharmacokinetics for single-dose multiple cytochrome P450 (CYP450) enzymes (CYP3A4, CYP2C9, CYP...

An Efficacy and Safety Study of JNJ-56021927 (ARN-509) in High-risk Prostate Cancer Subjects Receiving Primary Radiation Therapy: ATLAS

The purpose of this study is to determine if JNJ-56021927 plus gonadotropin releasing hormone (GnRH) agonist in participants with high-risk, localized or locally advanced prostate cancer r...

Phase 1 Study of Abiraterone Acetate in Castration-resistant Prostate Cancer

The purpose of this study is to assess pharmacodynamics and safety of JNJ-212082 in order to select the recommended dose of JNJ-212082 for patients with castration resistant prostate cance...

PubMed Articles [3865 Associated PubMed Articles listed on BioPortfolio]

Ascleposide, a natural cardenolide, induces anticancer signaling in human castration-resistant prostatic cancer through Na /K -ATPase internalization and tubulin acetylation.

Cardiac glycosides, which inhibit Na /K -ATPase, display inotropic effects for the treatment of congestive heart failure and cardiac arrhythmia. Recent studies have suggested signaling downstream of N...

Inhibition of noncanonical Wnt pathway overcomes enzalutamide resistance in castration-resistant prostate cancer.

Because androgen receptor (AR) signaling is essential for prostate cancer (PCa) initiation and progression, castration is the main approach for treatment. Unfortunately, patients tend to enter a stage...

Systemic Management for Nonmetastatic Castration-resistant Prostate Cancer: A Systematic Review and Network Meta-Analysis.

To indirectly compare the efficacy and safety of systemic therapies used for patients with nonmetastatic castration-resistant prostate cancer (nmCRPC).

A novel androgen receptor antagonist JJ-450 inhibits enzalutamide-resistant mutant AR nuclear import and function.

Castration-resistant prostate cancer can develop resistance to enzalutamide because of androgen receptor (AR) point mutations, AR overexpression, constitutively active AR splice variants, and/or eleva...

Comparative assessment of docetaxel for safety and efficacy between hormone-sensitive and castration-resistant metastatic prostate cancer.

To compare toxicity and response of docetaxel chemotherapy between metastatic hormone-sensitive prostate cancer (mHSPC) and castration-resistant metastatic prostate cancer (mCRPC) patients of the same...

Medical and Biotech [MESH] Definitions

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

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).

An androstene derivative that inhibits STEROID 17-ALPHA-HYDROXYLASE and is used as an ANTINEOPLASTIC AGENT in the treatment of metastatic castration-resistant PROSTATE CANCER.

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.

More From BioPortfolio on "A Safety Study of JNJ-56021927 in Participants With Metastatic Castration-Resistant Prostate Cancer"

Quick Search

Relevant Topic

  Bladder Cancer Brain Cancer Breast Cancer Cancer Cervical Cancer Colorectal Head & Neck Cancers Hodgkin Lymphoma Leukemia Lung Cancer Melanoma Myeloma Ovarian Cancer Pancreatic Cancer ...

Searches Linking to this Trial