Nano albumin bound-paclitaxel in pancreatic cancer: Current evidences and future directions

Table 1 Patients characteristics in metastatic pancreatic cancer pivotal trials

	Gemcitabine	FOLFIRINOX	Nab-paclitaxel + gemcitabine
Trial (yr)	Gemcitabine vs 5-fluorouracil (1997)	FOLFIRINOX vs Gemcitabine (2011)	Nab-paclitaxel + Gemcitabine vs Gemcitabine (2013)
Phase	1	II-III	III
Countries	United states-Canada-United Kingdom	France	Worldwide
Patients	126	342	861
Median age	61.5	61	62
Elderly ( ≥ 75 yr)	Yes		Yes
ECOG PS 0-1	Yes	Yes	Yes
ECOG PS 2	Yes		Yes
Biliary Stent	Yes	Yes	Yes
Multiple metastatic sites	Yes	Yes	Yes

¹Phase not specified in the full paper. ECOG PS: Eastern Cooperative Oncology Group Performance Status.

Table 2 Principal clinical trials with nab-paclitaxel in metastatic pancreatic cancer

Study ID	Setting	Study drugs	Phase	Status
NCT02993731	Metastatic	Nab-paclitaxel + Gemcitabine +/-Napabucasin	III	Recruiting
NCT02101021	Metastatic	Nab-paclitaxel + Gemcitabine +/- Momelotinib	III	Active not recruiting
NCT02715804	Metastatic	Nab-paclitaxel + Gemcitabine +/-PEGPH20	III	Recruiting
NCT02436668	Metastatic	Nab-paclitaxel + Gemcitabine +/- Ibrutinib	II-III	Recruiting
NCT02827201	Metastatic	Sequential Nab-paclitaxel + Gemcitabine /FOLFIRI	II	Active not recruiting
NCT02767557	Metastatic	Nab-paclitaxel + Gemcitabine +/-tocilizumab	II	Recruiting
NCT03086369	Metastatic	Nab-paclitaxel + Gemcitabine +/- Olaratumab	II	Not yet recruiting
NCT02879318	Metastatic	Nab-paclitaxel + Gemcitabine +/- Durvalumab + Tremelimumab	II	Recruiting
NCT02399137	Metastatic	Nab-paclitaxel + Gemcitabine +	II	Recruiting
		MM-141
NCT02340117	Metastatic	Nab-paclitaxel + Gemcitabine +	II	Recruiting
		SGT-53
NCT02124317	Metastatic	Nab-paclitaxel + S-1	II	Active not recruiting
NCT03076216	Metastatic	Nab-paclitaxel + Gemcitabine + ONCOsil	II	Not yet recruiting
NCT02905578	Metastatic	Nab-paclitaxel + Gemcitabine +	II	Not yet recruiting
		High-dose ascorbate
NCT02732938	Metastatic	Nab-paclitaxel + Gemcitabine + PF-04136309	II	Recruiting
NCT02551991	Metastatic	Nal-Iri or Gemcitabine +	II	Recruiting
		Nab-paclitaxel
NCT03009058	Metastatic	Nab-paclitaxel + Gemcitabine +	I-II	Not yet recruiting
		IMM 101
NCT02559674	Metastatic	Nab-paclitaxel + Gemcitabine +	I-II	Recruiting
		ALT-803
NCT02705196	Metastatic	Nab-paclitaxel + Gemcitabine + LOAd703 oncolytic virus	I-II	Recruiting
NCT01834235	Metastatic	Nab-paclitaxel + Gemcitabine +	I-II	Active not recruiting
		NPC-1C
NCT01730222	Metastatic	Nab-paclitaxel + Gemcitabine + Capecitabine + Cisplatin	I-II	Recruiting
NCT02620800	Metastatic	Nab-paclitaxel + 5-fluorouracil + Leucovorin + Bevacizumab + Oxaliplatin	I-II	Recruiting
NCT01506973	Metastatic	Nab-paclitaxel + Gemcitabine + Hydroxychloroquine	I-II	Recruiting
NCT02504333	Metastatic	Nab-paclitaxel + Gemcitabine followed by FOLFOX	I-II	Recruiting
NCT02050178	Metastatic	Nab-paclitaxel + Gemcitabine + OMP-54F28	I	Active not recruiting
NCT02309177	Metastatic	Nab-paclitaxel + Nivolumab +/- Gemcitabine	I	Recruiting
NCT02514031	Metastatic	Nab-paclitaxel + Gemcitabine +	I	Recruiting
		ARQ-761
NCT01934634	Metastatic	Nab-paclitaxel + Gemcitabine + LCL161	I	Active not recruiting
NCT02101580	Metastatic	Nab-paclitaxel + Gemcitabine +	I	Active not recruiting
		ADI-PEG 20
NCT02138383	Metastatic	Nab-paclitaxel + Gemcitabine + Enzalutamide	I	Active not recruiting
NCT02975141	Metastatic	Nab-paclitaxel + Gemcitabine + Afatinib	I	Recruiting
NCT02227940	Metastatic	Nab-paclitaxel + Gemcitabine + Ceritinib	I	Recruiting
NCT02231723	Metastatic	Nab-paclitaxel + Gemcitabine +	I	Recruiting
		BBI608
NCT02501902	Metastatic	Nab-paclitaxel + Palbociclib	I	Recruiting

Nal-Iri: Nanoliposomal irinotecan.

Table 3 Principal clinical trials with nab-paclitaxel in pancreatic cancer “early settings”

Study ID	Setting	Study drugs	Phase	Status
NCT01964430	Adjuvant	Nab-paclitaxel + Gemcitabine vs Gemcitabine	III	Recruiting
NCT02506842	Adjuvant	Nab-paclitaxel + Gemcitabine vs OFF	III	Recruiting
NCT02023021	Adjuvant	Nab-paclitaxel + Gemcitabine	II	Recruiting
NCT02125136	Neoadjuvant	Nab-paclitaxel + Gemcitabine vs FOLFIFINOX	II	Recruiting
NCT02243007	Neoadjuvant	Nab-paclitaxel + Gemcitabine vs FOLFIFINOX	II	Recruiting
NCT02717091	Neoadjuvant/borderline resectable	Nab-paclitaxel + Gemcitabine vs FOLFIFINOX	II	Recruiting
NCT02481635	NEO/adjuvant	Nab-paclitaxel + Gemcitabine + radiotherapy	I-II	Recruiting
NCT01431794	Neoadjuvant	Nab-paclitaxel + Gemcitabine + LDE-225	I-II	Active not recruiting
NCT02588443	NEO/adjuvant	Nab-paclitaxel + Gemcitabine + RO7009789	I	Recruiting
NCT02272738	Neoadjuvant	Nab-paclitaxel + Gemcitabine + radiotherapy	I	Recruiting
NCT02506803	Neoadjuvant	Nab-paclitaxel + Gemcitabine	I	Recruiting
NCT02427841	Resectable	Nab-paclitaxel + Gemcitabine followed by radiotherapy	II	Recruiting
NCT02550327	Resectable	Nab-paclitaxel + Gemcitabine + Cisplatin + Anakinra	I	Recruiting
NCT02210559	Locally advanced	Nab-paclitaxel + Gemcitabine + FG-3019	I-II	Recruiting
NCT02394535	Locally advanced	Nab-paclitaxel + Capecitabine + radiotherapy	I	Recruiting
NCT02124369	Borderline unresectable	Nab-paclitaxel + Gemcitabine	II	Recruiting
NCT02043730	Unresectable locally advaced	Nab-paclitaxel + Gemcitabine	II	Recruiting
NCT02207465	Unresectable locally advanced	Nab-paclitaxel + Gemcitabine + radiotherapy	I	Recruiting
NCT02272738	Unresectable locally advanced	Nab-paclitaxel + Gemcitabine	I	Recruiting
NCT01978184	Preoperative	Nab-paclitaxel + Gemcitabine + Hydroxychloroquine	II	Recruiting
NCT02427841	Preoperative	Nab-paclitaxel + Gemcitabine + radiotherapy	II	Recruiting
NCT02723331	Preoperative	Nab-paclitaxel + Gemcitabine followed by SBRT	II	Recruiting
NCT02930902	Preoperative	Nab-paclitaxel + Gemcitabine + Pembrolizumab + Paricalcitol	I	Recruiting

SBRT: Stereotactic body radiotherapy; OFF: Oxaliplatin plus fluoro-folate.