NCT04566952

Anlotinib Combined With Dose-reduced Olaparib in Patients With Platinum-Sensitive Recurrent Ovarian Cancer

A Prospective, Single-arm, Single-center, Exploratory Phase II Study to Evaluate the Efficacy and Safety of Anlotinib Combined With Dose-reduced Olaparib in Patients With Platinum-Sensitive Recurrent Ovarian Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 68 (estimated)
• Sponsor: Xiaoxiang Chen · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

PARP inhibitors have changed the treatment paradigm of ovarian cancer. Most patients using PARP(poly-ADP ribose polymerase) inhibitors will suffer different grades of adverse events(AEs), followed by dose reduction. It has not been reported whether the dose-reduced olaparib as maintenance treatment have an impact on efficacy. Both PAOLA-1 and AVANOVA 2 studies showed that combined PARP inhibitors and antiangiogenic drugs have synergistic anti-tumor effect. Anlotinib is a novel multi-target tyrosine kinase inhibitor that can inhibit VEGFR(vascular endothelial growth factor receptor), FGFR(fibroblast growth factor receptor), PDGFR(platelet-derived growth factor receptor) α/β, c-Kit, and Ret. And anlotinib has been approved as orphan drug designations for treatment of ovarian cancer by FDA in 2015. Previous studies showed that anlotinib had manageable toxicity and promising antitumor effect. Our study is expected to investigate the efficacy and safety of anlotinib combined with dose-reduced olaparib as maintenance treatment in platinum-sensitive recurrent ovarian cancer patients.

Detailed description

This study is a single-arm, single-center, exploratory phase II study to observe the efficacy and safety of anlotinib combined with dose-reduced olaparib in patients with platinum-sensitive recurrent ovarian cancer, fallopian tube cancer and primary peritoneal cancer. We will enroll the subjects who are treated with olaparib as maintenance treatment followed by dose reduction due to adverse events. The primary end points are progression free survival and adverse events. The secondary end points include objective response rate, disease control rate, overall survival, time from enrollment to first subsequent treatment, quality of life.

Conditions

• Ovarian Cancer
• Ovarian and Fallopian Tube Cysts and Neoplasms
• Neoplasms by Site
• Neoplasms
• Genital Neoplasms, Female
• Urogenital Neoplasms
• Neoplasms, Glandular and Epithelial
• Neoplasms by Histologic Type
• Carcinoma, Ovarian Epithelial
• Ovarian Diseases
• Adnexal Diseases
• Genital Diseases, Female
• Carcinoma
• Anlotinib
• PARP Inhibitors
• BRCA1 Mutation
• Angiogenesis
• Antineoplastic Agents
• BRCA2 Mutation

Interventions

Type	Name	Description
DRUG	Anlotinib	Anlotinib will be treated with its minimum dose that is orally 8 mg daily on days 1-14 of a 21-days cycle.
DRUG	Olaparib	Olaparib will be treated with a total daily dose of 450 or 300mg.

Timeline

• Start date: 2020-10-28
• Primary completion: 2023-03-01
• Completion: 2023-10-01
• First posted: 2020-09-28
• Last updated: 2020-10-30

Locations

1 site across 1 country: China