Table 5.
Results of nanoformulations in clinical—examples of nanoformulations tested in recent clinical trials
| Nanoformulation | Phase of development | Indication | Conclusions from clinical trials | Reference |
|---|---|---|---|---|
| Liposome-encapsulated irinotecan (PEP02, MM-398) | Phase I | Advanced solid tumors | Improved pharmacokinetics and tumor bio-distribution of the free drug | [228] |
| Liposome-encapsulated irinotecan (NAPOLI-1) | Phase III | Gemcitabine-refractory metastatic pancreatic cancer | Extended survival with a controllable safety profile in combination with fluorouracil and folinic acid | [229] |
| Nab-paclitaxel with carboplatin | Phase IIa | Extensive-stage small cell lung cancer | Activity against ES-SCLC, but patients required frequent dose adjustments and treatment delays | [188] |
| Nab-paclitaxel with sirolimus | Phase Iba | Advanced solid tumors | Acceptable safety profile of sirolimus with nab-paclitaxel | [230] |
| Nanoparticulate paclitaxel | Phase I | Peritoneal malignancies | Low peritoneal clearance, minimal toxicity of treatment | [198] |
| Genexol-PM® | Phase II | Non-small cell lung cancer | Anti-tumor activity when combined with gemcitabine, but frequent 3/4 grade hematological toxicity was observed | [199] |
| Paclitaxel bound to poly-l-glutamic acid (Paclitaxel poliglumex) with capecitabine | Phase II | Metastatic breast cancer | Tolerable and effective treatment, but the combination failed to reach efficacy endpoint | [231] |
| Paclitaxel bound to poly-l-glutamic acid (Paclitaxel poliglumex) with radiation therapy | Phase II | Glioblastoma Without MGMT Methylation | Progression-free survival and overall survival was not improved | [232] |
| Doxil® with carboplatin, bevacizumab and veliparib | Phase I | Platinum-sensitive ovarian, primary peritoneal, and fallopian tube cancer | Lower doses of veliparib will need to be considered when given in combination with platinum-based therapies, dose limiting toxicity was noted | [192] |
| Doxil®/carboplatin with tocilizumab | Phase I | Recurrent epithelial ovarian cancer | Acceptable safety profile | [194] |
| PLD plus cyclophosphamide followed by paclitaxel | Phase II | Breast cancer | Effective and safe treatment for patients prone to conventional doxorubicin-induced cardiotoxicity | [197] |
| Myocet® | Phase I | Glioma | The maximum recommended dose was determined. Safety profile will be studied in further trials | [200] |
| PLD plus irinotecan | Phase I | Ovarian cancer | High tolerance to treatment | [195] |
PLD pegylated liposomal doxorubicin
a Study terminated