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

Sponsor
Xiaoxiang Chen
Study ID
NCT04566952
Phase
PHASE2
Status
Unknown

Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Oct 28, 2020
Status verified
Oct 2020
Primary completion
Mar 1, 2023
Completion
Oct 1, 2023

Study Design

Enrollment
68 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Anlotinib combined With dose-reduced olaparib
    Anlotinib-olaparib combination therapy until disease progression

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: Through study completion, an average of 1 year ]

Central Contacts

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