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A Phase I/II Study of HE3235 in Patients With Prostate Cancer - NCT00716794-95661(Clinical Trial 231223)



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City:  Roseville
State:  
CA
Zip Code: 95661
Conditions: Prostate Cancer
Purpose: This is a phase I/II, open-label, dose escalation study of HE3235 administered orally to patients with advanced prostate cancer who have failed hormone therapy and at least one taxane based chemotherapy regimen.
Study summary:
Criteria: Main Inclusion Criteria: - Patient is male and at least 18 years of age, at the time of screening; - Patient has metastatic disease (any T, any N, M1); - Patient has failed at least 1 taxane regimen; or Patient has symptomatic or asymptomatic CRPC and is chemotherapy-naïve - Patient has histologically or cytologically confirmed adenocarcinoma of the prostate; - Patient has progression of disease despite adequate hormone therapy, demonstrated by one of the following: - PSA level of at least 2 ng/ml that has risen on at least 2 successive occasions, at least 1 week apart. - Evaluable disease progression by modified RECIST (Response Evaluation Criteria in Solid Tumors) criteria; - Progression of metastatic bone disease on bone scan with > 2 new lesions - Patient has ECOG (Eastern Cooperative Oncology Group) performance status of 0-2; Main Exclusion Criteria: - Patient has symptomatic parenchymal brain metastases or active epidural disease requiring whole-brain irradiation Treated epidural disease is allowed - Patient has active infection; - Patient having a history of clinically significant cardiovascular disease (such as CHF), clinically significant hepatic, respiratory or renal abnormalities; - Patient who has any clinically significant abnormalities in laboratory results at screening - Patient who has a history of clinically significant neurological or psychiatric condition; Additional criteria are applicable to expansion cohorts.
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Data Source: ClinicalTrials.gov
Date Processed: February 17, 2011
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