Table 2.
Ongoing TAS-102 trials in mCRC
| Title | Trial | Ph | Patient population | Treatment | Primary outcome |
|---|---|---|---|---|---|
| A Phase I/II study for the safety and efficacy of panitumumab in combination with TAS-102 for patients with colorectal cancer (APOLLON) | NCT02613221 | I/II | 56, RAS wild-type refractory mCRC | Panitumumab + TAS-102 | PFS @ 6 months (Ph I: RP2D is standard dosing) |
| TAS-102 and radioembolization with 90Y resin microspheres for chemo-refractory colorectal liver metastases | NCT02602327 | I | 24, liver-dominant, refractory mCRC | 90Y TARE + TAS-102 | Safety (adverse events) |
| A study evaluating TAS-102 plus nivolumab in patients with MSS CRC | NCT02860546 | II | 35, MSS refractory mCRC | Nivolumab + TAS-102 | irORR |
| Phase I study of SGI-110 with irinotecan followed by randomized Phase II study of SGI-110 with irinotecan versus regorafenib or TAS-102 in previously treated mCRC | NCT01896856 | I/II | 108, refractory mCRC | SGI-110 + irinotecan vs regorafenib or TAS-102 | Safety (adverse events), ORR |
| Study of TAS-102 in patients with mCRC in Asia (TERRA) | NCT01955837 | III | 400, refractory mCRC, Asia only | TAS-102 vs PBO | OS |
| Phase II study of TAS-102/bevacizumab maintenance therapy post-induction chemotherapy in mCRC (ALEXANDRIA) | NCT02654639 | II | 45, maintenance (stable disease or better on first-line chemotherapy) | Bevacizumab + TAS-102 | PFS |
| Study of S 95005 in combination with oxaliplatin in mCRC | NCT02848443 | I | 94, mCRC, second line or greater | TAS-102 + oxaliplatin (± bevacizumab or nivolumab) | MTD |
| TAS-OX for refractory mCRC | NCT02848079 | I/II | 68, mCRC, third line or greater | Oxaliplatin + TAS-102 | ORR |
| A study evaluating S 95005 plus bevacizumab in patients with previously untreated colorectal cancer who are non-eligible for intensive therapy (TASCO1) | NCT02743221 | II | 150, mCRC, first line | TAS-102 + bevacizumab vs capecitabine + bevacizumab | PFS |
| Multicenter Phase Ib/II trial of nintedanib with TAS-102 in patients with mCRC who had progression or were intolerant to standard therapies (N-task force: EPOC1410) | UMIN000017114 | I/II | 52, mCRC refractory/intolerant | Nintedanib + TAS-102 | MTD, PFS @ 16 weeks |
Abbreviations: mCRC, metastatic colorectal cancer; PFS, progression-free survival; RP2D, recommended Phase II dose; TARE, transarterial radioembolization; MSS, microsatellite stable; irORR, immune-related objective response rate; CRC, colorectal cancer; ORR, objective response rate; PBO, placebo; OS, overall survival; Ph, phase; MTD, maximum tolerated dose.