A Randomized Phase II Evaluation of Weekly Ixabepilone With or Without Biweekly Bevacizumab in Recurrent or Persistent Platinum-resistant/Refractory Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancers

Trial ID # NCT03093155
Phase II
Drug Class Chemotherapy
Drug Name Ixabepilone
Alternate Drug Names Ixempra, Epothilone-B, epothilone B lactam, BMS-247550, Azaepothilone B
Drugs in Trial Bevacizumab, Ixabepilone
Eligible Participant

Platinum resistant, refractory or persistent ovarian cancer; median 3 prior therapies; 18% Pt-Rf, 55% w/ prior Bev

Patients Enrolled

78

Therapy Setting

Recurrence

Study Design

Open-Label, Randomized

Endpoints

ORR, PFS, OS, evaluated per RECIST

Efficacy

Ixa+Bev (n=39) vs Ixa (n=37):

ORR: 33 vs 8%, p=0.004
PFS: 5.5 vs 2.2 months, HR: 0.33 (0.19-0.55, p<0.001)
OS: 10.0 vs 6.0 months, HR: 0.52 (0.31-0.87, p=0.006)

Clinically Significant Adverse Events

Serious AE: 1 bowel perforation in Ixa+Bev arm
Grade 3-4 AE:

Conclusion

Ixabepilone+bevacizumab is a well-tolerated, effective combination for treatment of platinum/taxane resistant ovarian cancer that extends both PFS/OS relative to ixabepilone monotherapy and prior receipt of bevacizumab should not preclude use of ixabepilone+bevacizumab

Reference

Roque D et al. Randomized phase II trial of weekly ixabepilone with or without biweekly bevacizumab for platinum-resistant or refractory ovarian/fallopian tube/primary peritoneal cancer. SGO (2021) abstract 11570
https://www.clearityfoundation.org/wp-content/uploads/2021/03/SGO-11570-IxabepiloneBev.pdf

Roque D et al. Slide from presentation - prior Bev
https://www.clearityfoundation.org/wp-content/uploads/2021/05/IxabepiloneBev-slide-from-presenation-SGO-2021.pdf

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