NCT04822805

Brief Summary

This is a phase II, open-label, single center study, aiming to investigate safety and efficacy of anlotinib in treatment of recurrent high-grade glioma.

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
27

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2020

Typical duration for phase_2

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

Study Start

First participant enrolled

April 13, 2020

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 30, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2023

Completed
Last Updated

March 30, 2021

Status Verified

March 1, 2021

Enrollment Period

2.5 years

First QC Date

March 25, 2021

Last Update Submit

March 26, 2021

Conditions

Recurrent High-grade Glioma

Outcome Measures

Primary Outcomes (1)

  • progression-free survival

    The time interval from the randomization of the patient to the first disease progression or death from any cause

    5months

Study Arms (1)

Treatment with Anlotinib

EXPERIMENTAL

Patients with recurrent high-grade gliomas are being enrolled , treated with anlotinib 12mg once daily for 14 days every 3 weeks until disease progression or unacceptable toxicity.The dose can be adjusted to 10mg or 8mg according to the specific conditions of the patient.

Drug: Anlotinib hydrochloride

Interventions

Anlotinib hydrochlorideDRUG

Patients with recurrent high-grade gliomas are being enrolled , treated with anlotinib 12mg once daily for 14 days every 3 weeks until disease progression or unacceptable toxicity.The dose can be adjusted to 10mg or 8mg according to the specific conditions of the patient.

Also known as: Anlotinib
Treatment with Anlotinib

Eligibility Criteria

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

You may qualify if:

  • Age ≥18 years old (calculated on the day of signing the informed consent), regardless of gender.
  • Karnofsky score (KPS score) ≥60.
  • According to Rano criteria, there are evaluable intracranial lesions, and recurrent high-grade gliomas have been confirmed.
  • Patients have undergone surgery and relapsed after receiving standard radiotherapy and chemotherapy;
  • The toxicity has returned to ≤1 grade If have received chemotherapy;
  • Expected survival ≥ 3 months;
  • The patient has no major organ dysfunction. Specific laboratory indicators are required: white blood cells ≥3.0×109/L, platelets ≥75×109/L, hemoglobin ≥10g/dl, and serum bilirubin not greater than 1.5 times the maximum normal value; ALT and AST are not more than 2 times the maximum normal value; blood creatinine ≤ 1.5 mg/dl.
  • Men and women of gestational age must agree to take adequate contraceptive measures throughout the study period.
  • The patient voluntarily joined the study and signed a written informed consent.

You may not qualify if:

  • Those who have multiple factors that affect oral medications (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.);
  • Patients with any severe and/or uncontrollable disease, including:

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hangzhou Cancer Hospital

Hangzhou, 310000, China

RECRUITING

Related Publications (1)

  • Zhao S, Zhang M, Zhang Q, Wu J, Dai H. Anlotinib alone or in combination with bevacizumab in the treatment of recurrent high-grade glioma: a prospective single-arm, open-label phase II trial. BMC Cancer. 2024 Jan 2;24(1):6. doi: 10.1186/s12885-023-11776-4.

    PMID: 38166698DERIVED

MeSH Terms

Conditions

Glioma

Interventions

anlotinib

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

  • Hui Dai

    Hangzhou Cancer Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hui Dai

CONTACT

13968855810124186159@qq.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Patients with recurrent high-grade gliomas are being enrolled , treated with anlotinib , and being observed the disease-related outcomes of the patients.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2021

First Posted

March 30, 2021

Study Start

April 13, 2020

Primary Completion

October 30, 2022

Study Completion

March 30, 2023

Last Updated

March 30, 2021

Record last verified: 2021-03

Locations

CN(1)