Clinical Study on the Treatment of Recurrent Glioblastoma With Anlotinib

July 1, 2019 updated by: Rongjie Tao, Shandong Cancer Hospital and Institute

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250117
        • Recruiting
        • Shandong Cancer Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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:

  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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Fu Ke Wei

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
each 42 days up to PD or death(up to 24 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
each 42 days up to intolerance the toxicity or PD (up to 24 months)
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.
each 42 days up to intolerance the toxicity or PD (up to 24 months)
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.
From randomization until death (up to 24 months)
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.
each 42 days up to intolerance the toxicity or PD (up to 24 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shandong Cancer Hospital and Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 25, 2019

Primary Completion (Anticipated)

July 25, 2020

Study Completion (Anticipated)

July 25, 2021

Study Registration Dates

First Submitted

July 1, 2019

First Submitted That Met QC Criteria

July 1, 2019

First Posted (Actual)

July 2, 2019

Study Record Updates

Last Update Posted (Actual)

July 2, 2019

Last Update Submitted That Met QC Criteria

July 1, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ShandongCHI006

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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