None listed
Conditions
Interventions
PATIENTS MUST HAVE EVIDENCE OF DISEASE PROGRESSION DURING OR AFTER RECEIVING ≥
360 mg/m² OF DOCETAXEL, WITHIN A 6-MONTH PERIOD. PATIENTS WHO WERE CLEARLY INTOLERANT TO DOCETAXEL OR DEVELOP PROGRESSIVE DISEASE BEFORE RECEIVING ≥
360 mg/m² ARE ALSO ELIGIBLE IF THEY HAVE RECEIVED AT LEAST 225 mg/m² OF DOCETAXEL WITHIN A 6-MONTH PERIOD AND MEET THE OTHER STUDY ENTRY CRITERIA. WHEN CABAZITAXEL IS AVALAIBLE, SUITABLE PATIENTS MUST
Sponsors
Millennium Pharmaceuticals, Inc.,
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. MALE PATIENTS 18 YEARS OR OLDER. 2. VOLUNTARY WRITTEN CONSENT, GIVEN BEFORE PERFORMANCE OF ANY STUDY-RELATED PROCEDURE NOT PART OF STANDARD MEDICAL CARE, AND WITH THE UNDERSTANDING THAT CONSENT MAY BE WITHDRAWN AT ANY TIME WITHOUT PREJUDICE TO FUTURE MEDICAL CARE. 3. ADENOCARCINOMA OF THE PROSTATE HISTOLOGICALLY OR CYTOLOGICALLY CONFIRMED. 4. METASTASIC DISEASE RADIOGRAPHICALLY DOCUMENTED (CT/MRI, BONE SCAN). 5. PROGRESSIVE DISEASE, DEFINED AS 1 OR MORE OF THE FOLLOWING: • RADIOGRAPHIC DISEASE PROGRESSION BASED ON RECIST 1.1 (REFER TO SECTION 15.1) IN PATIENTS WITH MEASURABLE SOFT TISSUE LESIONS; IN PATIENTS WITH BONE DISEASE, PROGRESSION WILL BE ASSESSED FOLLOWING RECOMMENDATIONS BY THE PROSTATE CANCER WORKING GROUP (PCWG2; REFER TO SECTION 15.1): APPEARANCE OF 2 OR MORE LESIONS ON BONE SCAN, CONFIRMED BY OTHER IMAGING MODALITIES (SUCH AS CT SCAN OR MRI) IF RESULTS OF THE BONE SCANS ARE AMBIGUOUS. • PSA PROGRESSION IS DEFINED AS AN INCREASE IN PSA, DETERMINED FOR 2 SEPARATES MEASUREMENTS TAKEN AT LEAST 1 WEEK APART AND CONFIRMED BY A THIRD. IF THE THIRD MEASUREMENT IS NOT GREATER THAN THE SECOND MEASUREMENT, THEN A FOURTH MEASUREMENT MUST BE TAKEN, THE FOURTH MEASUREMENT MUST BE GREATER THAN THE SECOND MEASUREMENT FOR THE SUBJECT TO BE ELIGIBLE FOR ENROLLMENT IN THE STUDY.
Exclusion criteria
Exclusion criteria: 1. PRIOR THERAPY WITH ORTERONEL, KETOCONAZOLE, ABIRATERONE, OR AMINOGLUTETHIMIDE. 2. KNOWN HYPERSENSITIVITY TO COMPOUNDS RELATED TO ORTERONEL, TO ORTERONEL EXCIPIENTS, OR PREDNISONE, OR TO GnRH ANALOGUE. 3. THERAPY WITH BICALUTAMIDE WITHIN 6 WEEKS OF THE FIRST DOSE OF STUDY DRUG. ALL OTHER ANTIANDROGEN THERAPY IS EXCLUDED WITHIN 4 WEEKS PRIOR TO FIRST DOSE OF STUDY DRUG. 4. EXPOSURE TO RADIOISOTOPE THERAPY WITHIN 4 WEEKS OF RECEIVING THE FIRST DOSE OF STUDY DRUG; EXPOSURE TO EXTERNAL BEAM RADIATION WITHIN 2 WEEKS OF RECEIVING THE FIRST DOSE OF STUDY DRUG. 5. DOCUMENTED CENTRAL NERVOUS SYSTEM METASTASES. 6. TREATMENT WITH ANY INVESTGATIONAL COMPOUND WITHIN 30 DAYS PRIOR TO THE FIRST DOSE OF STUDY DRUG OR ONGOING PARTICIPATION IN ANOTHER EXPERIMENTAL TRIAL RELATED TO THE TREATMENT OF PC. 7. CURRENT SPINAL CORD COMPRESSION, CURRENT BILATERAL HYDRONEPHROSIS, OR CURRENT BLADDER NECK OUTLET OBSTRUCTION. 8. DIAGNOSIS OF, OR TREATMENT FOR, ANOTHER SYSTEMIC MALIGNANCY WITHIN 2 YEARS BEFORE TO THE FIRST DOSE STUDY DRUG, OR PREVIOUSLY DIAGNOSED WITH ANOTHER MALIGNANCY AND ANY EVIDENCE OF RESIDUAL DISEASE. PATIENTS WITH NON-MELANOMA SKIN CANCER OR CARCINOMA IN SITU OF ANY TYPE ARE NOT EXCLUDED IF THEY HAVE UNDERGONE COMPLETE RESECTION.
Countries
Australia, Belgium, Canada, Czech Republic, Estonia, Finland, France, Greece, Hungary, Italy, Netherlands, Poland, Spain, United States
Contacts
Public ContactLuis Miguel Melendez
PPD Peru S.A.C.
Outcome results
None listed