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Clinical Study on the Treatment of Recurrent Glioblastoma With Anlotinib

Primary Purpose

Recurrent Glioblastoma

Status

Unknown status

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

Anlotinib

About this trial

This is an interventional treatment trial for Recurrent Glioblastoma focused on measuring anlotinib Recurrent Glioblastoma

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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;

Exclusion Criteria:

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);

Sites / Locations

Shandong cancer hospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

anlotinib

Arm Description

12 mg daily from day 1 to 14 of a 21-day cycle

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Overall Survival (OS)

OS is defined as the time until death due to any cause.

Objective Response Rate (ORR)

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)

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)

use EORTC QLQ-C30(version 3) questionnaire to evaluate the quality of life.

Full Information

NCT ID

NCT04004975

First Posted

July 1, 2019

Last Updated

July 1, 2019

Sponsor

Shandong Cancer Hospital and Institute

1. Study Identification

Unique Protocol Identification Number

NCT04004975

Brief Title

Clinical Study on the Treatment of Recurrent Glioblastoma With Anlotinib

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Unknown status

Study Start Date

June 25, 2019 (Anticipated)

Primary Completion Date

July 25, 2020 (Anticipated)

Study Completion Date

July 25, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shandong Cancer Hospital and Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. 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.

Detailed Description

INCLUSION CRITERIA: 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; EXCLUSION CRITERIA: Exclusion Criteria: 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);

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Recurrent Glioblastoma

Keywords

anlotinib Recurrent Glioblastoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Model Description

one-armed controlled clinical trial

Masking

None (Open Label)

Masking Description

Open Label

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

anlotinib

Arm Type

Experimental

Arm Description

12 mg daily from day 1 to 14 of a 21-day cycle

Intervention Type

Drug

Intervention Name(s)

Anlotinib

Other Intervention Name(s)

Fu Ke Wei

Intervention Description

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.

Primary Outcome Measure Information:

Title

Progress free survival (PFS)

Description

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.

Time Frame

each 42 days up to PD or death(up to 24 months)

Secondary Outcome Measure Information:

Title

Overall Survival (OS)

Description

OS is defined as the time until death due to any cause.

Time Frame

From randomization until death (up to 24 months)

Title

Objective Response Rate (ORR)

Description

Time Frame

each 42 days up to intolerance the toxicity or PD (up to 24 months)

Title

Disease Control Rate (DCR)

Description

Defined as the proportion of patients with a documented complete response, partial response, and stable disease (CR + PR + SD) based on RECIST 1.1.

Time Frame

each 42 days up to intolerance the toxicity or PD (up to 24 months)

Title

Quality of Life score (QoL)

Description

use EORTC QLQ-C30(version 3) questionnaire to evaluate the quality of life.

Time Frame

each 42 days up to intolerance the toxicity or PD (up to 24 months)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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; Exclusion Criteria: 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);

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Rongjie Tao, Dr.

Phone

13969191909

rongjietao@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Jun Xu, Dr.

Phone

6762312

doctorwy@163.com

Facility Information:

Facility Name

Shandong cancer hospital

City

Jinan

State/Province

Shandong

ZIP/Postal Code

250117

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rongjie Tao, Dr.

Phone

13969191909

rongjietao@13.com

12. IPD Sharing Statement

Citations:

PubMed Identifier

29438373

Citation

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.

Results Reference

background

PubMed Identifier

29943374

Citation

Syed YY. Anlotinib: First Global Approval. Drugs. 2018 Jul;78(10):1057-1062. doi: 10.1007/s40265-018-0939-x. Erratum In: Drugs. 2018 Aug;78(12):1287.

Results Reference

result

PubMed Identifier

31145289

Citation

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.

Results Reference

result

PubMed Identifier

30231931

Citation

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.

Results Reference

result

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Clinical Study on the Treatment of Recurrent Glioblastoma With Anlotinib

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