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Clinical Study on the Treatment of Recurrent Glioblastoma With Anlotinib

Study Purpose

Anlotinib is a novel small molecule multi-target tyrosine kinase inhibitor that can inhibit tumor angiogenesis and inhibit tumor cell growth. We performed second-generation gene sequencing on pathological specimens and cerebrospinal fluid of patients with recurrent glioblastoma.If patients have a genetic mutation (VEGFR,Kit,PDGFR,FGFR)and meet other eligibility criteria, they will be treated with antroinib. The initial observation targets were progression-free survival and adverse reactions. The secondary objective was overal survival.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 80 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Histologically confirmed World Health Organization (WHO) Grade IV glioblastoma.; 2. Radiographic evidence of tumour progression or recurrence; 3. The second-generation gene sequencing on pathological specimens and cerebrospinal fluid show at least one genetic mutation of the four genes (VEGFR,Kit,PDGFR,FGFR); 4. ≥ 18 years of age; 5. Karnofsky performance status (KPS) ≥ 70; 6. Corticosteroid dose must be stable or decreasing for at least 5 days prior to the scan. 7. a new baseline scan is required 1.7 Measurable disease as per Response Assessment in Neuro-Oncology (RANO) criteria; 8. Estimated survival of at least 3 months; 9. signed informed consent form; 10. Hgb > 9 gm; absolute neutrophil count (ANC) > 1500/μl; platelets > 100,000; Creatinine < 1.5 times the upper limit of laboratory normal value; Bilirubin < 2 times the upper limit of laboratory normal value; serum glutamate pyruvate transaminase (SGPT) or serum glutamate oxaloacetate transaminase (SGOT) < 3 times the upper limit of laboratory normal value;

Exclusion Criteria:

1. Subjects with newly diagnosed GBM. 2. Pregnant women or nursing mothers cannot participate in the study. Women of childbearing age must have a negative pregnancy test within 72 hours prior to study entry. Women of childbearing potential must practice medically approved contraceptive precautions; 3. Abnormal hematological results at inclusion with: Neutrophils < 1,500/mm3; Blood-platelets < 100,000/mm3. 4. Severe or chronic renal insufficiency (creatinine clearance ≤ 30 ml/min); 5. Patient unable to follow procedures, visits, examinations described in the study; 6. Any usual formal indication against imaging examinations (important claustrophobia, pacemaker);

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04004975
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Shandong Cancer Hospital and Institute
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Unknown status
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Recurrent Glioblastoma
Additional Details

INCLUSION CRITERIA: 1. Histologically confirmed World Health Organization (WHO) Grade IV glioblastoma.; 2. Radiographic evidence of tumour progression or recurrence; 3. The second-generation gene sequencing on pathological specimens and cerebrospinal fluid show at least one genetic mutation of the four genes (VEGFR,Kit,PDGFR,FGFR); 4. ≥ 18 years of age; 5. Karnofsky performance status (KPS) ≥ 70; 6. Corticosteroid dose must be stable or decreasing for at least 5 days prior to the scan. 7. a new baseline scan is required 1.7 Measurable disease as per Response Assessment in Neuro-Oncology (RANO) criteria; 8. Estimated survival of at least 3 months; 9. signed informed consent form; 10. Hgb > 9 gm; absolute neutrophil count (ANC) > 1500/μl; platelets > 100,000; Creatinine < 1.5 times the upper limit of laboratory normal value; Bilirubin < 2 times the upper limit of laboratory normal value; serum glutamate pyruvate transaminase (SGPT) or serum glutamate oxaloacetate transaminase (SGOT) < 3 times the upper limit of laboratory normal value; EXCLUSION CRITERIA: Exclusion Criteria: 1. Subjects with newly diagnosed GBM. 2. Pregnant women or nursing mothers cannot participate in the study. Women of childbearing age must have a negative pregnancy test within 72 hours prior to study entry. Women of childbearing potential must practice medically approved contraceptive precautions; 3. Abnormal hematological results at inclusion with: Neutrophils < 1,500/mm3; Blood-platelets < 100,000/mm3. 4. Severe or chronic renal insufficiency (creatinine clearance ≤ 30 ml/min); 5. Patient unable to follow procedures, visits, examinations described in the study; 6. Any usual formal indication against imaging examinations (important claustrophobia, pacemaker);

Arms & Interventions

Arms

Experimental: anlotinib

12 mg daily from day 1 to 14 of a 21-day cycle

Interventions

Drug: - Anlotinib

Anlotinib is a multitarget receptor tyrosine kinase inhibitor which inhibits vascular endothelial growth factor receptor (VEGFR) 1-3, fibroblast growth factor receptor (FGFR) 1-4, platelet-derived growth factor receptors (PDGFR) α/β, c-Kit, and Met.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Shandong cancer hospital, Jinan, Shandong, China

Status

Recruiting

Address

Shandong cancer hospital

Jinan, Shandong, 250117

Site Contact

Rongjie Tao, Dr.

[email protected]

13969191909