NCT04004975

Clinical Study on the Treatment of Recurrent Glioblastoma With Anlotinib

Phase II Clinical Trials on Anlotinib for the Treatment of Recurrent Glioblastoma.

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Shandong Cancer Hospital and Institute · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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);

Conditions

• Recurrent Glioblastoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-06-25
• Primary completion: 2020-07-25
• Completion: 2021-07-25
• First posted: 2019-07-02
• Last updated: 2019-07-02

Locations

1 site across 1 country: China