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A Phase 1 Study of MDV3100 in Patients With Castration-Resistant (Hormone-Refractory) Prostate Cancer

2014-07-24 14:20:44 | BioPortfolio

Summary

This is a multi-center open-label dose-escalation study of a novel compound (MDV3100) to treat patients with castration-resistant (hormone-refractory) prostate cancer. Additional patients will be enrolled in expanded cohorts at doses determined to be tolerable. Patients who tolerate the drug and do not progress will be allowed to continue to look for PSA response.

Description

This is a Phase 1, open-label, uncontrolled, dose-escalation study with dose-expansion at doses determined to be tolerated. Patients who tolerate the drug and do not progress will be allowed to continue treatment. The study endpoints are safety and tolerability and pharmacokinetics. PSA values will also be collected to look for PSA response.

Study Design

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

Conditions

Prostate Cancer

Intervention

MDV3100

Location

Memorial Sloan-Kettering Cancer Center
New York City
New York
United States
10021

Status

Active, not recruiting

Source

Medivation, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:20:44-0400

Clinical Trials [2133 Associated Clinical Trials listed on BioPortfolio]

A Study of MDV3100 Versus Bicalutamide in Castrate Men With Metastatic Prostate Cancer

The purpose of this study is to determine the efficacy and safety of oral MDV3100 compared to bicalutamide in castrate men with metastatic prostate cancer who have progressed while on Lute...

A Study of MDV3100 to Evaluate Safety, Tolerability, Pharmacokinetics and Efficacy of in Prostate Cancer Patients

This study is to evaluate safety, tolerability pharmacokinetics and efficacy of MDV3100 after oral administration to patients with castration-resistant prostate cancer.

Safety and Efficacy Study of MDV3100 in Patients With Castration-Resistant Prostate Cancer Who Have Been Previously Treated With Docetaxel-based Chemotherapy

This is a phase 3 study to compare the clinical benefit of MDV3100 versus placebo in patients with castration-resistant prostate cancer who have been previously treated with docetaxel-base...

Determine the Effect of MDV3100 on the Androgen Signaling Pathway in Correlation With the Anti-tumor Effects of MDV3100 to Identify Potential Predictors of Response or Resistance to Therapy

This study is being conducted to determine the effect of MDV3100 on the androgen signaling pathway in correlation with the anti-tumor effects of MDV3100 to identify potential predictors of...

Enzalutamide in Patients With High-risk Prostate Cancer

The purpose of this study is to see how long it takes for prostate cancer to come back in patients who have had surgery to remove their prostate gland (radical prostatectomy), while being ...

PubMed Articles [13233 Associated PubMed Articles listed on BioPortfolio]

Radioligand therapy of metastatic castration-resistant prostate cancer: current approaches.

Prostate Cancer is the forth most common type of cancer. Prostate-specific membrane antigen (PSMA) is anchored in the cell membrane of prostate epithelial cells. PSMA is highly expressed on prostate e...

Developing new age-specific prostate-specific antigen thresholds for testing for prostate cancer.

To examine whether age-related reference ranges for "normal" prostate-specific antigen (PSA) change (determined in men without prostate cancer) can be used to identify men at high risk of having prost...

The Role of Testosterone Therapy in the Setting of Prostate Cancer.

The role of testosterone in the development of prostate cancer and the safety of testosterone therapy (TTh) after prostate cancer treatment, or in the setting of active surveillance, remains controver...

Modelling human prostate cancer: Rat models.

Prostate cancer is the second most common cancer in men, affecting approximately 1.1 million men worldwide. In this way, the study of prostate cancer biopathology and the study of new potential therap...

Association of zinc level and polymorphism in MMP-7 gene with prostate cancer in Polish population.

Prostate cancer is one of the most commonly diagnosed malignancies among men in Western populations. Evidence reported in the literature suggests that zinc may be related to prostate cancer. In this s...

Medical and Biotech [MESH] Definitions

A glycoprotein that is a kallikrein-like serine proteinase and an esterase, produced by epithelial cells of both normal and malignant prostate tissue. It is an important marker for the diagnosis of prostate cancer.

A synthetic retinoid that is used orally as a chemopreventive against prostate cancer and in women at risk of developing contralateral breast cancer. It is also effective as an antineoplastic agent.

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).

Proteins secreted by the prostate gland. The major secretory proteins from the human prostate gland include PROSTATE-SPECIFIC ANTIGEN, prostate-specific acid phosphatase, prostate-specific membrane antigen, and prostate-specific protein-94.

Tumors or cancer of the PROSTATE.

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