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

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