Clinical Study on the Treatment of Recurrent Glioblastoma With Anlotinib
Phase II Clinical Trials on Anlotinib for the Treatment of Recurrent Glioblastoma.
1 other identifier
interventional
50
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jun 2019
Typical duration for phase_1
1 active site
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
June 25, 2019
CompletedFirst Submitted
Initial submission to the registry
July 1, 2019
CompletedFirst Posted
Study publicly available on registry
July 2, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 25, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 25, 2021
CompletedJuly 2, 2019
July 1, 2019
1.1 years
July 1, 2019
July 1, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progress free survival (PFS)
PFS defined as the time from first dose of study treatment until the first date of either objective disease progression or death due to any cause.
each 42 days up to PD or death(up to 24 months)
Secondary Outcomes (4)
Overall Survival (OS)
From randomization until death (up to 24 months)
Objective Response Rate (ORR)
each 42 days up to intolerance the toxicity or PD (up to 24 months)
Disease Control Rate (DCR)
each 42 days up to intolerance the toxicity or PD (up to 24 months)
Quality of Life score (QoL)
each 42 days up to intolerance the toxicity or PD (up to 24 months)
Study Arms (1)
anlotinib
EXPERIMENTAL12 mg daily from day 1 to 14 of a 21-day cycle
Interventions
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.
Eligibility Criteria
You may qualify if:
- Histologically confirmed World Health Organization (WHO) Grade IV glioblastoma.;
- Radiographic evidence of tumour progression or recurrence;
- 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);
- ≥ 18 years of age;
- Karnofsky performance status (KPS) ≥ 70;
- Corticosteroid dose must be stable or decreasing for at least 5 days prior to the scan.
- a new baseline scan is required 1.7 Measurable disease as per Response Assessment in Neuro-Oncology (RANO) criteria;
- Estimated survival of at least 3 months;
- signed informed consent form;
- 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;
You may not qualify if:
- Subjects with newly diagnosed GBM
- 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;
- Severe or chronic renal insufficiency (creatinine clearance ≤ 30 ml/min);
- Patient unable to follow procedures, visits, examinations described in the study;
- Any usual formal indication against imaging examinations (important claustrophobia, pacemaker);
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shandong cancer hospital
Jinan, Shandong, 250117, China
Related Publications (4)
Han B, Li K, Zhao Y, Li B, Cheng Y, Zhou J, Lu Y, Shi Y, Wang Z, Jiang L, Luo Y, Zhang Y, Huang C, Li Q, Wu G. Anlotinib as a third-line therapy in patients with refractory advanced non-small-cell lung cancer: a multicentre, randomised phase II trial (ALTER0302). Br J Cancer. 2018 Mar 6;118(5):654-661. doi: 10.1038/bjc.2017.478. Epub 2018 Feb 13.
PMID: 29438373BACKGROUNDSyed YY. Anlotinib: First Global Approval. Drugs. 2018 Jul;78(10):1057-1062. doi: 10.1007/s40265-018-0939-x.
PMID: 29943374RESULTLv Y, Zhang J, Liu F, Song M, Hou Y, Liang N. Targeted therapy with anlotinib for patient with recurrent glioblastoma: A case report and literature review. Medicine (Baltimore). 2019 May;98(22):e15749. doi: 10.1097/MD.0000000000015749.
PMID: 31145289RESULTShen G, Zheng F, Ren D, Du F, Dong Q, Wang Z, Zhao F, Ahmad R, Zhao J. Anlotinib: a novel multi-targeting tyrosine kinase inhibitor in clinical development. J Hematol Oncol. 2018 Sep 19;11(1):120. doi: 10.1186/s13045-018-0664-7.
PMID: 30231931RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Masking Details
- Open Label
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief Physician
Study Record Dates
First Submitted
July 1, 2019
First Posted
July 2, 2019
Study Start
June 25, 2019
Primary Completion
July 25, 2020
Study Completion
July 25, 2021
Last Updated
July 2, 2019
Record last verified: 2019-07