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

NCT04566952 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2020-10-30

No results posted yet for this study

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.

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

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.

Sponsors & Collaborators

  • Xiaoxiang Chen

    lead OTHER

Principal Investigators

  • Xiaoxiang Chen, MD,PhD · Jiangsu Cancer Institute & Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-28
Primary Completion
2023-03-01
Completion
2023-10-01

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04566952 on ClinicalTrials.gov