Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 1:33 AM
NCT ID:
NCT00716794
Eligibility 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-naìˆve
* 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.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT00716794
Study Brief:
Protocol Section:
NCT00716794