|
| Target | Drug | Trial | Phase | Primary endpoint | Clinical trial identifier number |
|
| Androgen dependent pathways |
|
| CYP17 | TOK-001 (galeterone) | Single arm, open label, dose escalation, study of TOK-001 in chemotherapy naive mCRPC
| I/II | Safety, PSA response (≥50%) | NCT00959959 |
|
| AR | Enzalutamide (MDV 3100) | Randomized, double-blind, MDV3100 versus bicalutamide in CRPC | II | PFS at 24 months | NCT01664923 |
| Enzalutamide (MDV 3100) | Randomized, double-blind MDV3100 versus bicalutamide in CRPC | II | PFS at 24 months | NCT01288911 |
| ARN-509 | Open label, single arm, ARN-509 in CRPC | I/II | PSA response | NCT01171898 |
|
| AR mRNA antagonist | EZN-4176 | Open label, single arm study of EZN-4176 in CRPC | I | Maximum tolerated dose, safety | NCT01337518 |
|
| Androgen independent pathways |
|
| Src kinase | Dasatinib | Randomized, open label of cediranib and dasatinib versus cediranib and placebo in CRPC resistant to docetaxel | II | PFS | NCT01260688 |
| Dasatinib | Randomized, open label of abiraterone and prednisone with or without dasatinib in mCRPC | II | PFS | NCT01685125 |
| Saracatinib | Randomized, double-blind, saracatinib versus placebo in mCRPC with prior docetaxel
| II | Time to disease progression, PFS | NCT01267266 |
| Saracatinib | Single arm, saracatinib in mCRPC
| II | PSA response | NCT00513071 |
|
| mTOR | Everolimus (RAD001) | Single arm, RAD001 in mCRPC | II | Biochemical response rate | NCT00629525 |
| Everolimus (RAD001) | Single arm, RAD001 with docetaxel and bevacizumab in mCRPC | I/II | Safety | NCT00574769 |
| Everolimus (RAD001) | Single arm, RAD001 with docetaxel in mCRPC | I/II | Safety, objective response | NCT00459186 |
| Everolimus (RAD001) | Single arm, carboplatin, everolimus, and prednisone in mCRPC with prior docetaxel | II | Time to progression | NCT01051570 |
| Temsirolimus | Single arm, cixutumumab with temsirolimus in chemotherapy naive CRPC | I/II | Safety, objective response/PSA response | NCT01026623 |
| Ridaforolimus | Randomized, placebo controlled, bicalutamide with or without ridaforolimus in mCRPC | II | PSA response, dose limiting toxicities | NCT00777959 |
|
| IGF-1R | Figitumumab (CP-751871) | Randomized, noncomparative, two arm, open label, docetaxel and prednisone with and without figitumumab in mCRPC | II | PSA response, objective response | NCT00313781 |
| Cixutumumab (IMC-A12) | Single arm, open label, cixutumumab in chemotherapy naive mCRPC | II | Time to progression, pharmacokinetics | NCT00520481 |
| Cixutumumab (IMC-A12) | Single arm, cixutumumab with temsirolimus in chemotherapy naive CRPC | I/II | Safety, objective response/PSA response, and time to progression | NCT01026623 |
|
| Bcl-2 | Oblimersen | Randomized docetaxel with or without oblimersen in mCRPC | II | PSA response >30%, major toxic event rate <45%‡ | NCT00085228 |
| R-(-)-gossypol acetic acid (AT-101) | Randomized, docetaxel and prednisone with or without AT-101 in chemotherapy naive mCRPC | II | OS* | NCT00571675 |
|
| Hsp90 | STA-9090 | Single arm, open label, STA-9090 in mCRPC with prior docetaxel | II | PFS at 6 months | NCT01270880 |
|
| Hsp90 | AT13387 | Two arm, open-label, parallel group, randomized, AT13387 with or without abiraterone in mCRPC progressing on abiraterone | I/II | Safety and tolerability
response per PCWG2 | NCT01685268 |
|
| HDAC | Panobinostat (LBH589) | Single arm, panobinostat in mCRPC with prior docetaxel | II | PFS at 24 weeks | NCT00667862 |
| Panobinostat (LBH589) | Randomized panobinostat at two dose levels combined with bicalutamide for CRPC | I/II | Safety, dosing schedule, proportion free of progression and without symptomatic deterioration at 9 months | NCT00878436 |
| Vorinostat | Single arm, vorinostat for mCPRC with prior chemotherapy | II | PFS at 6 months** | NCT00330161 |
| SB939 | Open label, single arm, SB939 for recurrent or mCRPC | II | PFS
PSA response | NCT01075308 |
|
| DNA methyltransferase | Azacitidine | Single arm, docetaxel retreatment, and prednisone with azacitidine in mCRPC with prior docetaxel | I/II | Safety
PSA and objective response | NCT00503984 |
|
| Immunotherapy | Prostvac-VF | Randomized, open label, flutamide with and without Prostvac-VF in non-mCRPC | II | Time to treatment failure | NCT00450463 |
| Prostvac-VF | Randomized, open label, docetaxel and prednisone with or without Prostvac-VF in mCRPC | II | OS | NCT01145508 |
| 177Lu radiolabeled monoclonal antibody (Ab) HuJ591 (177Lu-J591) | Randomized ketoconazole and hydrocortisone plus 177Lu-J591 or placebo (111In-J591 ) in non-mCRPC | II | Proportion free of radiographically evident metastases at 18 months | NCT00859781 |
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