Phase I Evaluation of Lenvatinib and Weekly Paclitaxel in Patients With Recurrent Endometrial, Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Trial ID # NCT02788708
Phase I
Drug Class Angiogenesis Inhibitors: VEGFR/PDGFR
Drug Name Lenvatinib
Alternate Drug Names Lenvima, ER-203492-00, E7080
Drugs in Trial Lenvatinib, Paclitaxel
Eligible Participant

Platinum-resistant ovarian cancer or recurrent endometrial cancer

Patients Enrolled

26 [19 ovarian: 13 high-grade serous, 2 low-grade serous, 2 clear cell, 1 endometrioid, and 1 carcinosarcoma; median 3 prior therapies (1-5)]

Therapy Setting

Recurrence

Study Design

Open-Label, Non-randomized

Endpoints

ORR, PFS, RP2D, evaluated per RECIST

Efficacy

RP2D: 16 mg of lenvatinib with 80 mg/m2 paclitaxel weekly
ORR: 65% (1CR, 14PR, n=23)
DCR: 95.6% (1CR, 14PR, 7SD, n=23)
PFS: 14.0 months (5.1-NR)

ORR (OvCa): 71%
PFS (OvCa): 14.0 months

Clinically Significant Adverse Events

Grade 3-4 AE: hypertension (19%), neutropenia (15%), leukopenia (12%), anemia (12%)

Conclusion

Lenvatinib and weekly paclitaxel combination shows promising response rates

Reference

Backes FJ et al. Phase I evaluation of lenvatinib and weekly paclitaxel in patients with recurrent endometrial, ovarian, fallopian tube, or primary peritoneal cancer. SGO (2019) Abstract LBA5
https://www.targetedonc.com/conference/sgo-2019/lenvatinib-plus-paclitaxel-shows-activity-in-ovarian-endometrial-cancers