NCT03924882

Brief Summary

The purpose of the study is to evaluate the efficacy and toxicity of anlotinib in patients with platinum resistant or refractory ovarian cancer

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_2 ovarian-cancer

Timeline
Completed

Started Apr 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 21, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 23, 2019

Completed
2 days until next milestone

Study Start

First participant enrolled

April 25, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 25, 2022

Completed
Last Updated

April 23, 2019

Status Verified

April 1, 2019

Enrollment Period

2 years

First QC Date

April 21, 2019

Last Update Submit

April 21, 2019

Conditions

Ovarian Cancer

Keywords

Anlotinib; Ovarian cancer

Outcome Measures

Primary Outcomes (1)

  • Objective response rate (ORR)

    Objective response rate defined as confirmed complete response or partial response under RECIST 1.1 criteria. CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no fewer than 4 weeks after the response criteria are first met.

    Up to three years

Secondary Outcomes (3)

  • Progression-free survival (PFS)

    Up to three years

  • Duration of Response

    Up to three years

  • Frequency and severity of adverse effects as defined by CTCAE version 4.03

    30 days after last dose

Interventions

AnlotinibDRUG

Anlotinib QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female, age ≥18 years and ≤70 years, signed informed consent.
  • Histologically or pathologically confirmed diagnosis of epithelial carcinoma of the ovary.
  • Platinum resistant ovarian cancer (defined as relapsing within 6 months after the last administration of platinum-based chemotherapy) OR platinum refractory ovarian cancer (defined as progressing while on a platinum-based chemotherapy)
  • At least treated with one line of platinum-based chemotherapy
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 version or CA125
  • Patients must have a life expectancy of at least 3 months.
  • Patients must have adequate organ function.

You may not qualify if:

  • Had prior exposure to anlotinib or has known allegies to any of the excipients, Inadequately controlled hypertension
  • History of myocardial infarction, or unstable angina, or New York Heart Association (NYHA) Grade III-IV within 6 months prior to Day 1.
  • History of abdominal fistula or gastrointestinal perforation within 28 days prior to Day 1
  • Major surgical procedure within 28 days prior to Day 1, Serious, non-healing wound, active ulcer, bowel obstruction within 28 days prior to Day 1
  • Symptomatic central nervous system (CNS) metastasis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Affiliated hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

anlotinib

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Study Officials

  • Jianwei Zhou, M.D.

    Second Affiliated Hospital, School of Medicine, Zhejiang University

    STUDY CHAIR

Central Study Contacts

Zhigang Zhang, M.D.

CONTACT

15088621550zzg2011@zju.edu.cn

Jianwei Zhou, M.D.

CONTACT

0571-89713634jianwei-zhou@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2019

First Posted

April 23, 2019

Study Start

April 25, 2019

Primary Completion

April 25, 2021

Study Completion

April 25, 2022

Last Updated

April 23, 2019

Record last verified: 2019-04

Locations

CN(1)