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 cancer stemness inhibitor BBI608, BBI608
Drugs in Trial Napabucasin, Paclitaxel
Eligible Participant

Platinum-resistant/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)
http://meetinglibrary.asco.org/content/171455-176

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://meetinglibrary.asco.org/record/148814/abstract