Advertisement

Topics

A Safety and Efficacy Study of KX2-391 in Patients With Bone-Metastatic, Castration-Resistant Prostate Cancer Who Have Not Received Prior Chemotherapy

2014-08-27 03:15:42 | BioPortfolio

Summary

The standard of care for patients with bone-metastatic, castrate-resistant prostate cancer is chemotherapy. If a patient elects not to choose chemotherapy, 70% will progress within 6 months. KX2-391 given orally twice a day for 6 months will be evaluated for its ability to delay/prevent disease progression in patients who have not had prior chemotherapy.

Description

This is a multi-center, single-arm, open-label, prospective phase II clinical trial evaluating the efficacy, safety and pharmacokinetics of orally administered KX2-391 in adult male patients with progressive bone-metastatic CRPC. Patients must have 1) documented bone-metastatic prostate cancer, 2) castrate levels of testosterone, 3) not received prior chemotherapy, and 4) documented disease progression based on rising PSA, progressive measurable visceral disease and/or progressive bone lesions (one criteria is sufficient) as per the Prostate Cancer Clinical Trials Working Group (PCWG2) guidelines (Scher et al 2008).

Study Design

Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Bone-Metastatic, Castration-Resistant Prostate Cancer

Intervention

KX2-391

Location

University of Chicago
Chicago
Illinois
United States
60637

Status

Recruiting

Source

Kinex Pharmaceuticals, LLC

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:42-0400

Clinical Trials [6839 Associated Clinical Trials listed on BioPortfolio]

Study on Olaparib Plus Abiraterone as First-line Therapy in Men With Metastatic Castration-resistant Prostate Cancer

The purpose of this study is to evaluate the efficacy and safety (including evaluating side effects) of combination of olaparib and abiraterone versus placebo and abiraterone in patients w...

Study of Apalutamide and Abiraterone Acetate in Castration-Resistant Bone Metastatic Prostate Cancer Patients

The goal of this clinical research study is to learn if apalutamide in combination with abiraterone acetate and prednisone can help to control metastatic (has spread) castration-resistant ...

A Phase I/II, Safety Clinical Trial of DCVAC/PCa and ONCOS-102 in Men With Metastatic Castration-resistant Prostate Cancer

This clinical trial is to evaluate the safety of the combination of DCVAC/PCa with ONCOS-102 in men with castration-resistant advanced metastatic prostate cancer, who have progressed follo...

Sequencing of Radium-223 and Docetaxel in Symptomatic Bone-only Metastatic Castration-resistant Prostate Cancer

Randomized, multicentre phase II trial of the sequencing of Radium-223 and Docetaxel plus prednisone in symptomatic bone-only metastatic castration-resistant prostate cancer (mCRPC) Open-...

European Observational Study of Enzalutamide in Metastatic Castration Resistant Prostate Cancer (mCRPC)

The purpose of this study is to evaluate the effectiveness of enzalutamide in patients with metastatic castration resistant prostate cancer (mCRPC) in the clinical practice setting as meas...

PubMed Articles [20388 Associated PubMed Articles listed on BioPortfolio]

Quantification of bone flare on F-NaF PET/CT in metastatic castration-resistant prostate cancer.

Bone flare has been observed on Tc-MDP bone scans of patients with metastatic castration-resistant prostate cancer (mCRPC). This exploratory study investigates bone flare in mCRPC patients receiving a...

Novel nomograms for castration-resistant prostate cancer and survival outcome in patients with de novo bone-metastatic prostate cancer.

To develop nomograms predicting the incidence of castration resistant prostate cancer (CRPC) and overall survival (OS) for de novo metastatic prostate cancer (mPCa).

Risk factors for early castration-resistant prostate cancer after androgen deprivation therapy for bone-metastatic prostate cancer.

To investigate the risk factors for early castration-resistant prostate cancer (CRPC) after androgen deprivation therapy (ADT) in patients primarily diagnosed with bone-metastatic prostate cancer (BMP...

Abiraterone in metastatic castration-resistant prostate cancer: Efficacy and safety in unselected patients.

Abiraterone acetate (AA), an androgen biosynthesis inhibitor, is now a standard of care for men with metastatic, castration-sensitive and castration-resistant prostate cancer (mCRPC). Data exploring r...

Enzalutamide in Men with Nonmetastatic, Castration-Resistant Prostate Cancer.

Men with nonmetastatic, castration-resistant prostate cancer and a rapidly rising prostate-specific antigen (PSA) level are at high risk for metastasis. We hypothesized that enzalutamide, which prolon...

Medical and Biotech [MESH] Definitions

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

A synthetic long-acting agonist of GONADOTROPIN-RELEASING HORMONE. Goserelin is used in treatments of malignant NEOPLASMS of the prostate, uterine fibromas, and metastatic breast cancer.

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.

More From BioPortfolio on "A Safety and Efficacy Study of KX2-391 in Patients With Bone-Metastatic, Castration-Resistant Prostate Cancer Who Have Not Received Prior Chemotherapy"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topic

Osteoporosis
Osteoporosis is a disease in which the bones become extremely porous, are subject to fracture, and heal slowly, occurring especially in women following menopause and often leading to curvature of the spine from vertebral collapse. Follow and track&n...


Searches Linking to this Trial