NCT04253873

Brief Summary

Gliomas are the most common malignant tumors of the central nervous system and are highly invasive. Gliomas account for one-third of central nervous system tumors in adults and children. Interstitial astrocytomas and glioblastomas are also called high-grade gliomas, accounting for 77.5% of all gliomas.

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
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Dec 2019

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

December 16, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 31, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

February 5, 2020

Status Verified

January 1, 2020

Enrollment Period

2 years

First QC Date

January 31, 2020

Last Update Submit

January 31, 2020

Conditions

High-grade Gliomas

Outcome Measures

Primary Outcomes (1)

  • 6-month PFS rate

    Proportion of progression-free survival up to 6 months

    up to 1 year

Secondary Outcomes (3)

  • Progression-free survival (PFS)

    up to 1 year

  • Overall survival (OS)

    up to 1 year

  • Objective response rate (ORR)

    up to 1 year

Study Arms (1)

Apatinib mesylate + temozolomide

EXPERIMENTAL

Apatinib mesylate tablets (0-14 days, 500 mg, qd), one week apart, then temozolomide (150mg/m2, 5 days);Every 28 days is a cycle, the drug until the disease progress, the toxicity of intolerable.

Drug: Apatinib

Interventions

ApatinibDRUG

Apatinib mesylate (0-14 days, 500 mg, qd), taken half an hour after a meal (the daily dose should be as much as possible), one week apart, and then given temozolomide (150mg/m2 for 5 Days); every 28 days is a cycle, medication to disease progression, intolerable toxicity, etc.

Also known as: temozolomide
Apatinib mesylate + temozolomide

Eligibility Criteria

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

You may qualify if:

  • \. Age: 18 \~ 70 years old, male or female; 2. ECOG score: 0-2 points; 3. Expected survival time ≥ 3 months; 4. Patients diagnosed with high-grade (WHO III, IV) gliomas by pathology, and patients whose disease recurrence is judged by contrast imaging, have at least one measurable lesion on the skull magnetic resonance; 5. Patients who have not been controlled or relapsed after previous first-line standard treatment; 6. The main organs function normally, that is, they meet the following standards:
  • The blood routine examination standards must be met (no blood transfusion and blood products within 14 days, no correction using G-CSF and other hematopoietic stimulating factors)
  • HB≥90 g / L;
  • ANC≥1.5 × 109 / L;
  • PLT≥80 × 109 / L;
  • Biochemical inspection must meet the following standards:
  • TBIL \<1.5ULN;
  • ALT and AST \<2.5ULN, but \<5ULN for patients with liver metastases;
  • Serum Cr≤1.25ULN or endogenous creatinine clearance rate\> 45 ml / min (Cockcroft-Gault formula); 7. Women of childbearing age must have taken reliable contraceptive measures or performed a pregnancy test (serum or urine) within 7 days before enrollment, with negative results, and be willing to use appropriate methods during the test and 8 weeks after the last dose contraception. For men, consent must be given to appropriate contraception or surgical sterilization during the trial and 8 weeks after the last test drug administration; 8. Participants voluntarily joined the study and signed informed consent, with good compliance and cooperation with follow-up.

You may not qualify if:

  • \. Pregnant or lactating women; 13. Have previously used other anti-angiogenic drugs or preparations.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henan Cancer Hospital

Zhengzhou, Henan, 450008, China

RECRUITING

MeSH Terms

Interventions

apatinibTemozolomide

Intervention Hierarchy (Ancestors)

DacarbazineTriazenesOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Hui Wu, archiater

    Henan Cancer Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hui Wu, archiater

CONTACT

13503716710wuhui7008@126.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

January 31, 2020

First Posted

February 5, 2020

Study Start

December 16, 2019

Primary Completion

December 30, 2021

Study Completion

December 30, 2022

Last Updated

February 5, 2020

Record last verified: 2020-01

Locations

CN(1)