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: Multi-targeted RTK
Drug Name	Lenvatinib
Alternate Drug Names	MK-7902, 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: 14 high-grade serous, 1 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, DoR, PFS, RP2D, evaluated per RECIST
Efficacy	RP2D: 16 mg of lenvatinib with 80 mg/m2 paclitaxel weekly ORR (OvCa): 71% (incl. 1 LGS for 33+ months, 2 clear cell, 1 carcinosarcoma) DoR: 8.2 months PFS (OvCa): 7.2 months
Clinically Significant Adverse Events	Serious AE: one bowel perforation Grade 3-4 AE: hypertension (27%), anemia (19%), lymphopenia (19%), neutropenia (19%), leukopenia (15%), diarrhea (12%)
Conclusion	Lenvatinib+weekly paclitaxel shows promising response rates in platinum resistant ovarian cancer, also in patients with rare histologies
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. Gynecol Oncol (2021) 162(3):619-625 https://pubmed.ncbi.nlm.nih.gov/34272090/