Table 2.
Main ongoing clinical trials with CDKis in Endometrial Cancer.
| Description | Condition | Line of Therapy | Primary Endpoint | Phase | Status | Trial Identifier |
|---|---|---|---|---|---|---|
| Palbociclib | ||||||
| Palbociclib | Ovarian teratomas, GCTs or tumours with alteration at the G1/S checkpoint. | na | ORR, Safety | II | Recruiting | NCT01037790 |
| Palbociclib+ cisplatin or carboplatin | Solid tumours | na | %AEs, DLT, RP2D | I | Recruiting | NCT02897375 |
| Palbociclib | Solid tumours with alteration at the G1/S checkpoint. | >2 line | ORR | II | Recruiting | NCT02465060 |
| Letrozole+ Palbociclib/Letrozole +placebo | Metastatic EC | No more than 1 prior line of ET | PFS | II | Recruiting | NCT02730429 |
| Palbociclib + Gedatolisib | Solid tumours | na | %AEs, DLT, RP2D | I | Recruiting | NCT03065062 |
| RIBOCICLIB | ||||||
| Ribociclib +Letrozole | OC and EC | na | %PFS at 12 weeks | II | Active, not recruiting | NCT02657928 |
| Ribociclib+ everolimus + Letrozole | EC | ≤ 3 line | DLT/CBR | I/II | Recruiting | NCT03008408 |
| ABEMACICLIB | ||||||
| LY3023414 (PI3Ki) and Abemaciclib +/− Letrozole | EC | na | PFS at 6 months, ORR | II | Not yet recruiting | NCT03675893 |
| Fulvestrant+ Abemaciclib | EC | 1 or 2 line | ORR | II | Recruiting | NCT03643510 |
| OTHER CDKIS | ||||||
| Dinaciclib + Veliparib | Solid tumours with BRCA mutation | na | RP2D | I | Recruiting | NCT01434316 |
| Seliciclib+ Sapacitabine | Solid tumours | na | MTD | I | Unknown | NCT00999401 |
| CYC065 | Solid tumours or lymphomas | na | DLTs | I | Recruiting | NCT02552953 |
Legend: AEs: Adverse Events; DLTs: Dose Limiting Toxicities; EC: Endometrial Cancer; GCT: Granulosa Cell Tumours; MTD: Maximum Tolerated Dose; NA: not available; OC: Ovarian Cancer; ORR: Overall Response Rate; PI3Ki: PI3K inhibitor; RP2D: Recommended Phase II Dose.