A Safety and Efficacy Study of KX2-391 in Patients With Bone-Metastatic, Castration-Resistant Prostate Cancer Who Have Not Received Prior Chemotherapy
| Status: | Archived |
|---|---|
| Conditions: | Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | February 2010 |
| End Date: | August 2011 |
A Phase II, Open-Label, Single-Arm Study Evaluating the Safety, Efficacy and Pharmacokinetics of KX2-391 in Patients With Bone-Metastatic, Castration-Resistant Prostate Cancer Who Have Not Had Prior Chemotherapy
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).
We found this trial at
5
sites
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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University of Chicago One of the world's premier academic and research institutions, the University of...
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Wayne State University Founded in 1868, Wayne State University is a nationally recognized metropolitan research...
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University of Wisconsin-Madison In achievement and prestige, the University of Wisconsin-Madison has long been recognized...
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University of Washington Founded in 1861 by a private gift of 10 acres in what...
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