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A Study of Apatinib in Recurrent or Recurrent High-grade Glioma

Primary Purpose

Glioma

Status

Unknown status

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Apatinib

About this trial

This is an interventional treatment trial for Glioma

Eligibility Criteria

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

Inclusion Criteria:

1. Age ≥ 18 years old, male or female;
2. The histologically confirmed first-line after the surgical resection of the WHOIII / IV glioma or previous surgery and / or radiotherapy and chemotherapy after the recurrence of WHOIII / IV glioma;
3. ECOG score: 0-2 points;
4. The main organs function properly, that is, meet the following criteria:(1) blood test:a. HGB≥90 g / L;b. ANC ≧ 1.5 × 109 / L;c. PLT ≥80 × 109 / L;(2) biochemical examination:a. ALB≥30g / L;b. ALT and AST <2*ULN;c. TBIL≤1.5*ULN; d. Plasma Cr≤1.5 *ULN;
5. No history of mental illness in patients;
6. Thyroid function is normal;
7. Subjects volunteered to join the study, signed informed consent, good compliance, with follow-up.

Exclusion Criteria:

1. Pregnant or lactating women;
2. Hypertensive patients who are not well controlled by antihypertensive medication (systolic blood pressure> 150 mmHg and diastolic blood pressure> 100 mmHg); those with grade I or greater myocardial ischemia or myocardial infarction, arrhythmia (including QT Period ≥ 440 ms) and grade I cardiac insufficiency, grading reference NCI-CTC AE 3.0;
3. Unable to swallow, chronic diarrhea and intestinal obstruction, significantly affect the medication and absorption;
4. Have a clear gastrointestinal bleeding concerns (such as local active ulcer lesions, fecal occult blood ++ above), within 6 months history of gastrointestinal bleeding;
5. Have mental illness, or history of substance abuse;
6. Patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin, or their analogues; allowing the use of small doses of prophylaxis for prophylaxis, provided that the prothrombin time has an International Normalized Ratio (INR) ≤1.5 Farin (1 mg orally, once daily), low dose heparin (6,000 to 12,000 U daily for adults), or low dose aspirin (80 to 100 mg daily);
7. Researchers think it is not suitable for inclusion. All patients underwent CT or MRI of the head one week prior to the start of the protocol, with intracranial hemorrhage.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

apatinib

Arm Description

apatinib 500 mg orally daily until the untolerabale toxicities、desease progress or death

Outcomes

Primary Outcome Measures

Overall Survival(OS)

The length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive.

Progress-free Survival(PFS)

The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse.

Secondary Outcome Measures

Objective Response Rate(ORR)

Proportion of patients with reduction in tumor burden of a predefined amount

EORTC QLQ-C30

The EORTC Quality of Life questionnaires are developed to assess the quality of life of cancer patients.

Full Information

NCT ID

NCT03390062

First Posted

December 19, 2017

Last Updated

December 26, 2017

Sponsor

West China Hospital

Collaborators

Jiangsu HengRui Medicine Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03390062

Brief Title

A Study of Apatinib in Recurrent or Recurrent High-grade Glioma

Official Title

An One Arm, Open and Prospective Studyof Apatinib for the Treatment of Recurrent or Recurrent High-grade Glioma

Study Type

Interventional

2. Study Status

Record Verification Date

December 2017

Overall Recruitment Status

Unknown status

Study Start Date

January 4, 2018 (Anticipated)

Primary Completion Date

December 20, 2019 (Anticipated)

Study Completion Date

August 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

West China Hospital

Collaborators

Jiangsu HengRui Medicine Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to determine the effectiveness and safety of Apatinib for patients with Recurrent or Recurrent High-grade Glioma.

6. Conditions and Keywords

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

Glioma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

apatinib

Arm Type

Experimental

Arm Description

apatinib 500 mg orally daily until the untolerabale toxicities、desease progress or death

Intervention Type

Drug

Intervention Name(s)

Apatinib

Other Intervention Name(s)

Aitan

Intervention Description

Apatinib, also known as YN968D1, is a tyrosine kinase inhibitor that selectively inhibits the vascular endothelial growth factor receptor-2 (VEGFR2, also known as KDR). It is an orally bioavailable, small molecule agent which is thought to inhibit angiogenesis in cancer cells; specifically apatinib inhibits VEGF-mediated endothelial cell migration and proliferation thus blocking new blood vessel formation in tumor tissue.

Primary Outcome Measure Information:

Title

Overall Survival(OS)

Description

The length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive.

Time Frame

24 month

Title

Progress-free Survival(PFS)

Description

The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse.

Time Frame

24month

Secondary Outcome Measure Information:

Title

Objective Response Rate(ORR)

Description

Proportion of patients with reduction in tumor burden of a predefined amount

Time Frame

6month

Title

EORTC QLQ-C30

Description

The EORTC Quality of Life questionnaires are developed to assess the quality of life of cancer patients.

Time Frame

24month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 1. Age ≥ 18 years old, male or female; 2. The histologically confirmed first-line after the surgical resection of the WHOIII / IV glioma or previous surgery and / or radiotherapy and chemotherapy after the recurrence of WHOIII / IV glioma; 3. ECOG score: 0-2 points; 4. The main organs function properly, that is, meet the following criteria:(1) blood test:a. HGB≥90 g / L;b. ANC ≧ 1.5 × 109 / L;c. PLT ≥80 × 109 / L;(2) biochemical examination:a. ALB≥30g / L;b. ALT and AST <2*ULN;c. TBIL≤1.5*ULN; d. Plasma Cr≤1.5 *ULN; 5. No history of mental illness in patients; 6. Thyroid function is normal; 7. Subjects volunteered to join the study, signed informed consent, good compliance, with follow-up. Exclusion Criteria: 1. Pregnant or lactating women; 2. Hypertensive patients who are not well controlled by antihypertensive medication (systolic blood pressure> 150 mmHg and diastolic blood pressure> 100 mmHg); those with grade I or greater myocardial ischemia or myocardial infarction, arrhythmia (including QT Period ≥ 440 ms) and grade I cardiac insufficiency, grading reference NCI-CTC AE 3.0; 3. Unable to swallow, chronic diarrhea and intestinal obstruction, significantly affect the medication and absorption; 4. Have a clear gastrointestinal bleeding concerns (such as local active ulcer lesions, fecal occult blood ++ above), within 6 months history of gastrointestinal bleeding; 5. Have mental illness, or history of substance abuse; 6. Patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin, or their analogues; allowing the use of small doses of prophylaxis for prophylaxis, provided that the prothrombin time has an International Normalized Ratio (INR) ≤1.5 Farin (1 mg orally, once daily), low dose heparin (6,000 to 12,000 U daily for adults), or low dose aspirin (80 to 100 mg daily); 7. Researchers think it is not suitable for inclusion. All patients underwent CT or MRI of the head one week prior to the start of the protocol, with intracranial hemorrhage.

Central Contact Person:

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

ping Li, M.D.

Phone

08618980602780

lipinglunwen@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

qing Mao, M.D.

Organizational Affiliation

West China Hospital

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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A Study of Apatinib in Recurrent or Recurrent High-grade Glioma

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