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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.
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).
Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Bone-Metastatic, Castration-Resistant Prostate Cancer
University of Chicago
Kinex Pharmaceuticals, LLC
Published on BioPortfolio: 2014-08-27T03:15:42-0400
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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.
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