Table 5 Results of nanoformulations in clinical—examples of nanoformulations tested in recent clinical trials

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 II^a

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 Ib^a

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]