Table 3.
Some of the major ongoing clinical trials investigating the efficacy of ceritinib against different malignancies
| Clinical trial identifier | Study design | Treatment setting | Intervention | Primary endpoint |
|---|---|---|---|---|
| NCT01828099 | Phase III RCT | Metastatic treatment naïve ALK + NSCLC | Ceritinib versus platinum/Pemetrexed | PFS |
| NCT01828112 | Phase III RCT | Metastatic previously treated (with chemo and crizotinib) ALK + NSCLC | Ceritinib versus Docetaxel or Pemetrexed | PFS |
| NCT02289144 | Phase II | Locally advanced or metastatic ALK + anaplastic thyroid cancer | Ceritinib | PFS |
| NCT02374489 | Phase II | ROS1 or ALK overexpressed advanced cholangiocarcinoma | Ceritinib | ORR |
| NCT01964157 | Phase II | Unresectable NSCLC carrying ROS1 rearrangement | Ceritinib | ORR |
| NCT02393625 | Phase I | Relapsed locally advanced or metastatic ALK + NSCLC | Ceritinib plus nivolumab | MTD(br)ORR |
| NCT02321501 | Phase I | Locally advanced or metastatic previously treated solid tumor with an expansion in ALK + NSCLC | Ceritinib plus everolimus | MTD |
| NCT01685138 | Phase II | ALK + crizotinib naïve metastatic NSCLC | Ceritinib | ORR |
| NCT02336451 | Phase II | ALK + NSCLC with CNS metastasis | Ceritinib | ORR |
| NCT02299505 | Phase I | ALK + metastatic NSCLC | Low dose ceritinib taken with low-fat meal versus standard dose ceritinib at fasting | PK |
| NCT02227940 | Phase I | Advanced solid tumor or locally advanced/metastatic pancreatic cancer | Ceritinib combined with gemcitabine-based chemotherapy | MTD |
| NCT02343679 | Phase II | ALK + refractory/relapsed hematological malignancies | Ceritinib | ORR |
Abbreviations: PFS, progression free survival; ORR, overall response rate; MTD, maximum tolerated dose; CNS, central nervous system; NSCLC, Non-small-cell lung carcinoma; ALK, anaplastic lymphoma kinase; PK, pharmacokinetic.