A Phase Ib/II Clinical Study of BBI608 Administered With Paclitaxel in Adult Patients With Advanced Malignancies

Trial ID #	NCT01325441
Phase	II
Drug Class	Signaling Pathway Inhibitors: JAK-STAT/STAT3
Drug Name	Napabucasin
Alternate Drug Names	BBI608, cancer stemness inhibitor BBI608
Drugs in Trial	Napabucasin, Paclitaxel
Eligible Participant	Platinum resistant or refractory ovarian cancer
Patients Enrolled	98; median 4 prior therapies
Therapy Setting	Recurrence
Study Design	Open-Label, Non-randomized
Endpoints	ORR, DCR, PFS, OS, RP2D, evaluated per RECIST
Efficacy	RP2D: Nap 500mg bid + Pac 80 mg/m2 IV once weekly on 3 of every 4 weeks ORR: 20% (2CR, 13PR, n=75) DCR (2 months): 65% DCR (6 months): 27% PFS: 3.3 months (n=98) OS: 9.9 months (n=98)
Clinically Significant Adverse Events	Serious AE: none Grade 3-4 AE: reversible diarrhea (12.2%)
Conclusion	Encouraging signs of anti-cancer activity in a heavily-pretreated population
Reference	Garcia AA et al. A phase Ib/II study of cancer stemness inhibitor napabucasin (BB608) combined with weekly paclitaxel in platinum-resistant ovarian cancer. J Clin Oncol (2016) 34 (suppl; abstr 5578) https://ascopubs.org/doi/abs/10.1200/JCO.2016.34.15_suppl.5578 Becerra C et al. A phase 1b/2 study of napabucasin with weekly paclitaxel in advancer, previously treated platinum resistant ovarian cancer. J Clin Oncol (2017) 35 (suppl; abstr 5548) https://ascopubs.org/doi/abs/10.1200/JCO.2017.35.15_suppl.5548