Copyright ©The Author(s) 2016.
World J Gastroenterol. Aug 21, 2016; 22(31): 7080-7090
Published online Aug 21, 2016. doi: 10.3748/wjg.v22.i31.7080
Table 1 Selected ongoing trials with nab-paclitaxel in pancreatic adenocarcinoma
TrialTrial phaseTreatment regimenPrimary endpointPlanned patients number
NCT01964430 (APACT) after resectionIIIAdjuvant nab-paclitaxel and gemcitabine vs gemcitabine aloneDisease-free survival800
NCT02562716 (SWOG 1505) in resectable diseaseIIPerioperative nab-paclitaxel and gemcitabine vs FOLFIRINOX2-yr overall survival112
NCT02047513 (NEONAX) in resectable diseaseIIPerioperative nab-paclitaxel and gemcitabine vs adjuvant nab-paclitaxel and gemcitabineDisease-free survival166
NCT01921751 (RTOG 1201) in locally advanced diseaseIIUpfront nab-paclitaxel and gemcitabine followed by standard vs high intensity radiation2-yr overall survival346
NCT02301143 (LAPACT) in locally advanced diseaseIIUpfront treatment with nab-paclitaxel and gemcitabineTime to treatment failure110
NCT02436668 (RESOLVE) in metastatic diseaseIII1st-line with nab-paclitaxel and gemcitabine ± ibrutinibProgression-free survival326
NCT02715804 (HALO-301) in metastatic diseaseIII1st-line with nab-paclitaxel and gemcitabine ± PEGPH20Progression-free and overall survival420
NCT02399137 (CARRIE) in metastatic diseaseII1st-line with nab-paclitaxel and gemcitabine ± istiratumabProgression-free survival260
NCT02551991 in metastatic diseaseII1st-line nab-paclitaxel and gemcitabine, vs nal-IRI/LV/5-FU ± oxaliplatinProgression-free survival rate at 24 wk168
Table 2 Selected nanomedicines studied in clinical trials for pancreatic adenocarcinoma
NanomedicineNanoplatformStatusReference/trial information
Nanoplatin (NC-6004)Polymeric nanoparticle (PEG-polyaspartate) of cisplatinPhase III on going in advanced disease as 1st-line; 290 patients expectedNCT02043288; gemcitabine ± NC6004
EndoTAG-1Cationic liposome encapsulated paclitaxelPhase II (with gemcitabine vs gemcitabine) published in 2012Löhr et al[56] 2012/NCT00377936
Genexol-PMMethoxy-PEG-poly(D,L-lactide) basedPhase II monotherapy published in 2010Saif et al[65] 2010/NCT00111904
formulation of paclitaxel
Rexin-GPathotropic nanoparticle with cytocidal cyclin G1 constructPhase I/II monotherapy published in 2010Chawla et al[66] 2010/NCT00504998
LipoplatinLiposomal formulation of cisplatinPhase I/II (with gemcitabine) published in 2006Stathopoulos et al[67] 2006
Caelyx/DoxilLiposomal formulation of doxorubicinPhase II monotherapy published in 1995 and 2001Schwartz et al[68] 1995; Halford et al[69] 2001