A Randomized Gene Fusion Stratified Phase 2 Trial Of Abiraterone With Or Without ABT 888 For Patients With Metastatic Castration-Resistant Prostate Cancer (NCI# 9012)
1. This research is being done to look at the role of a specific gene hybrid formed from two previously separate genes (known as ETS gene fusion) to see if it can predict response to abiraterone (a hormone therapy) with prednisone or abiraterone with prednisone plus the investigational drug ABT-888 in people with metastatic (cancer that has spread throughout the body) castration resistant prostate cancer. 2. The researchers in this study will also look at whether the addition of ABT-888 to abiraterone with prednisone is better when compared to abiraterone and prednisone without ABT-888.
Must have diagnosis of progressive metastatic castration resistant prostate cancer, on androgen deprivation therapy, agree to have a biopsy of at least one metastatic site, goodperformance status, 18 years or older, may have had up to 2 prior chemotherapy regimens, must have good blood/liver/kidney function, must agree to use effective contraception while on study, must be ablew to take oral meds without crushing/dissolving/chewing tablets, must not have history of active seizures, must not have history of pituitary/adrenal dysfunction/hepatitis or chrinic liver disease, must not have known brain metastasis
After consenting to the study, all patients will have tissue sampled for analysis - If a patient is determined to be eligible and after all screening testing is done, patients will then be randomized into one of 4 groups - ETS gene positive patients AND ETS gene negative patients will receive either Abiraterone orally once daily along with Prednisone orally twice daily for 28 days (in a 28 day cycle) OR the previous medications along with ABT-888 orally twice daily in the same cycle sequence - Treatment will be given on an outpatient basis - patients will be required to come to the clinic every week for the first 3 cycles - scans will be done every 12 weeks - if there is stable or improved disease status, patient may remain on study and continued for another 3 cycles of treatment with visits every cycle (28 days) followed by scans again - this may continue until disease progression.
04/24/2014 04:02 AM