| 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) |
| Clinically Significant Adverse Events | Serious AE: none |
| 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) 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) |
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January 1, 2025,
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OCRA and Clearity are committed to serving the ovarian cancer community and providing the education, information, and support people need.