Table 2.
Ongoing studies testing AR-directed therapies in cancers other than breast or prostate cancer. Enza, enzalutamide; AR, androgen receptor; and MTD, maximum tolerated dose.
| Indication | Therapeutic Agent(s) | Disease State | Study Phase | Sample Size | Primary Endpoint | NCT Number |
|---|---|---|---|---|---|---|
| Endometrial cancer | Enza + carboplatin + paclitaxel | Advanced | Phase II | 69 | Safety/objective tumor response | NCT02684227 |
| Hepatocellular carcinoma | Enza vs. placebo | Advanced | Phase II | 144 | Overall survival | NCT02528643 |
| Hepatocellular carcinoma | Enza vs. Enza + sorafenib | Advanced | Phase I/II | 73 | Safety | NCT02642913 |
| Non-muscle invasive bladder cancer | Enza | Localized (chemoprevention) | Phase II | 50 | Recurrence rate | NCT02605863 |
| Bladder cancer | Enza + cisplatin + gemcitabine | Advanced | Phase I | 24 | MTD | NCT02300610 |
| AR positive ovarian cancer | Enza | Advanced | Phase II | 58 | Response rate: complete and partial responses | NCT01974765 |
| Pancreatic cancer | Enza + gemcitabine + nab-paclitaxel | Advanced | Phase I | 38 | MTD | NCT02138383 |
| Renal cell carcinoma | Enza | Localized (neoadjuvant) | Pilot/Phase 0 | 20 | Cell proliferation and tumor apoptosis | NCT02885649 |
| Mantle cell lymphoma | Enza | Advanced | Pilot/Phase 0 | 20 | Response rate: complete and partial responses | NCT02489123 |
| AR positive salivary cancer | Enza | Advanced | Phase II | 45 | Response rate: complete and partial responses | NCT02749903 |