TABLE 1.
Key clinical trial targeting IGF-1 axis in solid tumors.
| Title | ID number | Drug regimen | Phase and design | Primary outcome | Status |
| A dose escalating clinical trial of the IGF-1 receptor inhibitor AXL1717 in patients with advanced cancer | NCT01062620 | AXL1717 | Ia/b Single arm, open label | RPTD, MTD | Completed, results published |
| A phase I study of the oral mTOR inhibitor ridaforolimus (RIDA) in combination with the IGF-1R antibody dalotozumab (DALO) in patients (pts) with advanced solid tumors. | NCT00730379 | Ridaforolimus plus dalotozumab | I Single arm, open label | Optimal dose, MTD | Completed, results published |
| A phase 2 study of ridaforolimus (RIDA) and dalotuzumab (DALO) in estrogen receptor positive (ER+) breast cancer | NCT01605396 | Ridaforolimus + dalotozumab VS examestane | II Randomized, parallel assignment, open label | PFS | Completed, results published |
| A phase I trial of the IGF-1R antibody ganitumab (AMG 479) in combination with everolimus (RAD001) and panitumumab in patients with advanced cancer | NCT01061788 | AMG 479 + RAD001 VS AMG 479 + RAD001 + panitumumab | I Single center, dose escalation trial | MTD, RPTD | Completed |
| Phase I study of everolimus (E, RAD001) and ganitumab (GANG 479) in patients (pts) with advanced solid tumors | NCT01122199 | Everolimus + ganitumab | I Single arm, open label | MTD, RPTD | Completed |
| A phase Ib/II study of the combination of BYL719 plus AMG 479 in adult patients with selected solid tumors | NCT01708161 | BYL719 (alpelisib) and AMG 479 (ganitumab) | I/II Multicenter, open label, single arm | DLT, ORR | Terminated |
| The XENERATM 1 study tests xentuzumab in combination with everolimus and exemestane in women with hormone receptor positive and HER2-negative breast cancer that has spread | NCT03659136 | Everolimus + exemestane VS everolimus + exemestane + xentuzumab | II Two arm, open label | PFS | Recruiting |
| Capecitabine and lapatinib ditosylate with or without cixutumumab in treating patients with previously treated HER2-positive stage IIIB-IV breast cancer | NCT00684983 | Capecitabine plus lapatinib ± cixutumumab | II Randomized, parallel assignment, open label | PFS | Completed |
MTD, maximum tolerated dose; RPTD, recommended phase II dose; PFS, progression free survival; DLT, dose limiting toxicities.