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出境医 / 临床实验 / Clinical Study on the Treatment of Recurrent Glioblastoma With Anlotinib

Clinical Study on the Treatment of Recurrent Glioblastoma With Anlotinib

Study Description
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.

Condition or disease Intervention/treatment Phase
Recurrent Glioblastoma Drug: Anlotinib Phase 1 Phase 2

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);
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: one-armed controlled clinical trial
Masking: None (Open Label)
Masking Description: Open Label
Primary Purpose: Treatment
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
Arms and Interventions
Arm Intervention/treatment
Experimental: anlotinib
12 mg daily from day 1 to 14 of a 21-day cycle
 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.
Other Name: Fu Ke Wei
Outcome Measures
Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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);
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Rongjie Tao, Dr. 13969191909 rongjietao@163.com
Contact: Jun Xu, Dr. 6762312 doctorwy@163.com

Locations
Layout table for location information
China, Shandong
Shandong cancer hospital Recruiting
Jinan, Shandong, China, 250117
Contact: Rongjie Tao, Dr.    13969191909    rongjietao@13.com   
Sponsors and Collaborators
Shandong Cancer Hospital and Institute
Tracking Information
First Submitted Date  ICMJE July 1, 2019
First Posted Date  ICMJE July 2, 2019
Last Update Posted Date July 2, 2019
Estimated Study Start Date  ICMJE June 25, 2019
Estimated Primary Completion Date July 25, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 1, 2019) 		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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 1, 2019)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Study on the Treatment of Recurrent Glioblastoma With Anlotinib
Official Title  ICMJE Phase II Clinical Trials on Anlotinib for the Treatment of Recurrent Glioblastoma.
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.
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);
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
one-armed controlled clinical trial
Masking: None (Open Label)
Masking Description:
Open Label
Primary Purpose: Treatment
Condition  ICMJE Recurrent Glioblastoma
Intervention  ICMJE 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.
Other Name: Fu Ke Wei
Study Arms  ICMJE Experimental: anlotinib
12 mg daily from day 1 to 14 of a 21-day cycle
Intervention: Drug: Anlotinib
Publications *
  • 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.
  • Syed YY. Anlotinib: First Global Approval. Drugs. 2018 Jul;78(10):1057-1062. doi: 10.1007/s40265-018-0939-x. Review. Erratum in: Drugs. 2018 Aug;78(12):1287.
  • Lv 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. Review.
  • Shen 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. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 1, 2019) 		50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 25, 2021
Estimated Primary Completion Date July 25, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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);
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Rongjie Tao, Dr. 13969191909 rongjietao@163.com
Contact: Jun Xu, Dr. 6762312 doctorwy@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04004975
Other Study ID Numbers  ICMJE ShandongCHI006
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rongjie Tao, Shandong Cancer Hospital and Institute
Study Sponsor  ICMJE Shandong Cancer Hospital and Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Shandong Cancer Hospital and Institute
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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