A Phase I/Ib Study of Paclitaxel in Combination With VS-6063, a Focal Adhesion Kinase Inhibitor, in Subjects With Advanced Ovarian Cancer

Trial ID # NCT01778803
Phase I
Drug Class Signaling Pathway Inhibitors: Integrins-FAK/FAK
Drug Name Defactinib
Alternate Drug Names VS-6063, PF-04554878
Drugs in Trial Defactinib, Paclitaxel
Eligible Participant

Recurrent ovarian cancer

Patients Enrolled

22 patients; median 3 prior therapies, 17 Pt-R

Therapy Setting

Recurrence

Study Design

Open-Label, Non-randomized

Endpoints

ORR, DCR, evaluated per RECIST

Efficacy

ORR: 18.2% (2CR, 2PR, n=22)
DCR: 63.6% (2CR, 2PR, 10SD)

Clinically Significant Adverse Events

Serious AE:
Grade 3-4 AE:

Conclusion

Defactinib + weekly paclitaxel is well tolerated and showed promising activity

Reference

Patel MR et al. Phase 1/1b study of the FAK inhibitor defactinib (VS-6063) in combination with weekly paclitaxel for advanced ovarian cancer. J Clin Oncol (2014) 32:5s (suppl; abstr 5521)
https://ascopubs.org/doi/abs/10.1200/jco.2014.32.15_suppl.5521

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