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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
Sponsor:
Information provided by (Responsible Party):
Rongjie Tao, Shandong Cancer Hospital and Institute

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);

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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
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

Resource links provided by the National Library of Medicine


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




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.



Information from the National Library of Medicine

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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);

Information from the National Library of Medicine

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


Contacts
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Contact: Rongjie Tao, Dr. 13969191909 rongjietao@163.com
Contact: Jun Xu, Dr. 6762312 doctorwy@163.com

Locations
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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

Publications of Results:
Other Publications:
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Responsible Party: Rongjie Tao, Chief Physician, Shandong Cancer Hospital and Institute
ClinicalTrials.gov Identifier: NCT04004975     History of Changes
Other Study ID Numbers: ShandongCHI006
First Posted: July 2, 2019    Key Record Dates
Last Update Posted: July 2, 2019
Last Verified: July 2019

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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
Keywords provided by Rongjie Tao, Shandong Cancer Hospital and Institute:
anlotinib Recurrent Glioblastoma
Additional relevant MeSH terms:
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Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue