A Phase 1/2a/3 Evaluation of the Safety and Efficacy of Adding AL3818 (Anlotinib, INN: Catequentinib), a Dual Receptor Tyrosine Kinase Inhibitor, to Standard Platinum-Based Chemotherapy in Subjects With Recurrent or Metastatic Endometrial, Ovarian, Fallopian, Primary Peritoneal or Cervical Carcinoma

Trial ID #	NCT02584478
Phase	Ia/II/III
Drug Class	Angiogenesis Inhibitors: Multi-targeted RTK
Drug Name	Anlotinib
Alternate Drug Names	Catequentinib, AL3818
Drugs in Trial	Anlotinib, Liposomal doxorubicin, Paclitaxel, Topotecan
Eligible Participant	Platinum resistant ovarian cancer
Patients Enrolled	51; median 4 prior therapies (1-11)
Therapy Setting	Recurrence
Study Design	Open-Label, Non-randomized
Endpoints	ORR, DCR, DoR, PFS, evaluated per RECIST
Efficacy	Anl+Pac, PLD or Top (n=46) ORR: 43% DCR: 91% DoR: 5.9 months PFS: 6.3 months Anl+Pac (n=29): ORR: 55% DCR: 90% DoR: 6.4 months PFS: 6.7 months
Conclusion	Anlotinib demonstrates positive combined synergic efficacy with chemotherapy in platinum resistant ovarian cancer
Reference	Miller DS et al. PHASE 2 STUDY ASSESSING THE EFFICACY OF ADDING AL3818 (CATEQUENTINIB DIHYDROCHLORIDE, ANLOTINIB HYDROCHLORIDE) TO CHEMOTHERAPIES IN SUBJECTS WITH PLATINUM RESISTANT OVARIAN CARCINOMA. ESGO (2022) abstract 722 https://www.clearityfoundation.org/wp-content/uploads/2023/01/Anlotinib-w-chemo-for-Pt-R-ESGO-2022.pdf