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

Ovarian Cancer Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

  • Adnexal Diseases
  • Angiogenesis
  • Anlotinib
  • Antineoplastic Agents
  • BRCA1 Mutation
  • BRCA2 Mutation
  • Carcinoma
  • Carcinoma, Ovarian Epithelial
  • Genital Diseases, Female
  • Genital Neoplasms, Female
  • Hypersensitivity
  • Neoplasms
  • Neoplasms by Histologic Type
  • Neoplasms by Site
  • Neoplasms, Glandular and Epithelial
  • Ovarian and Fallopian Tube Cysts and Neoplasms
  • Ovarian Cancer
  • Ovarian Diseases
  • Ovarian Neoplasms
  • PARP Inhibitors
  • Urogenital Neoplasms
Clinical Trial Details
NCT number NCT04566952
Study type Interventional
Source Jiangsu Cancer Hospital (Jiangsu Institute of Cancer Research, Nanjing Medical University Affiliated Cancer Hospital)
Contact Xiaoxiang Chen, MD,PhD
Phone +86 13851647229
Email cxxxxcyd@gmail.com
Status Recruiting
Phase Phase 2
Start date October 28, 2020
Completion date October 1, 2023
View Details
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