Clinical Study on the Treatment of Recurrent Glioblastoma With Anlotinib
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|ClinicalTrials.gov Identifier: NCT04004975|
Recruitment Status : Recruiting
First Posted : July 2, 2019
Last Update Posted : July 2, 2019
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Glioblastoma||Drug: Anlotinib||Phase 1 Phase 2|
- 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;
- 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;
- Abnormal hematological results at inclusion with: Neutrophils < 1,500/mm3; Blood-platelets < 100,000/mm3
- 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);
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||one-armed controlled clinical trial|
|Masking:||None (Open Label)|
|Masking Description:||Open Label|
|Official Title:||Phase II Clinical Trials on Anlotinib for the Treatment of Recurrent Glioblastoma.|
|Estimated Study Start Date :||June 25, 2019|
|Estimated Primary Completion Date :||July 25, 2020|
|Estimated Study Completion Date :||July 25, 2021|
12 mg daily from day 1 to 14 of a 21-day cycle
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.
Other Name: Fu Ke Wei
- Progress free survival (PFS) [ Time Frame: each 42 days up to PD or death(up to 24 months) ]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.
- Overall Survival (OS) [ Time Frame: From randomization until death (up to 24 months) ]OS is defined as the time until death due to any cause.
- Objective Response Rate (ORR) [ Time Frame: each 42 days up to intolerance the toxicity or PD (up to 24 months) ]ORR is defined as the percentage of subjects with evidence of a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1.prior to progression or any further therapy.
- Disease Control Rate (DCR) [ Time Frame: each 42 days up to intolerance the toxicity or PD (up to 24 months) ]Defined as the proportion of patients with a documented complete response, partial response, and stable disease (CR + PR + SD) based on RECIST 1.1.
- Quality of Life score (QoL) [ Time Frame: each 42 days up to intolerance the toxicity or PD (up to 24 months) ]use EORTC QLQ-C30(version 3) questionnaire to evaluate the quality of life.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04004975
|Contact: Rongjie Tao, Dr.||firstname.lastname@example.org|
|Contact: Jun Xu, Dr.||email@example.com|
|Shandong cancer hospital||Recruiting|
|Jinan, Shandong, China, 250117|
|Contact: Rongjie Tao, Dr. 13969191909 firstname.lastname@example.org|