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 @ 1:14 AM
Ignite Modification Date:
2025-12-25 @ 1:14 AM
NCT ID:
NCT01599793
Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically confirmed prostate cancer with progressive disease
* Evidence of castration resistance defined as disease progression despite a testosterone level \< 50ng/dL (or surgical castration)
* Evidence of metastatic disease to the bones within the lumbar spine, sacrum, or pelvic bones that is identifiable on screening pelvic MRI
* If patient has had prior pelvis radiation therapy (RT), then bone metastases must be out of radiated port (e.g. lumbar or sacral spine)
* Any prior therapy for castrate disease acceptable other than prior XL184 with a minimum washout of 28 days for any other anticancer therapy
* Patients with castrate resistant disease post antiandrogen therapy/withdrawal must meet at least one of the following criteria:
* Have not received docetaxel chemotherapy
* Have received docetaxel chemotherapy but received less then 225mg/m2 cumulative dose
* Have documented liver metastases
* Have no pain or pain that does not require a long acting (SR) narcotic
* Have received mitoxantrone chemotherapy in the past for CRPC
Exclusion Criteria:
* Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study
* Patients who are receiving any other investigational agents
* Prior treatment with other vascular endothelial growth factor (VEGF) or c-MET targeted therapies
* History of hematemesis or hemoptysis
* The subject has uncontrolled or significant intercurrent illness
* The patient requires concomitant treatment, in therapeutic doses, with anticoagulants
Healthy Volunteers:
False
Sex:
MALE
Study:
NCT01599793
Study Brief:
Protocol Section:
NCT01599793