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

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

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

Study Overview

• Status: Unknown
• Conditions: Glioma
• Intervention / Treatment: Drug: Apatinib

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

Drug: Apatinib; 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.; Other Names: Aitan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 month
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.	24month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate(ORR)	Proportion of patients with reduction in tumor burden of a predefined amount	6month
EORTC QLQ-C30	The EORTC Quality of Life questionnaires are developed to assess the quality of life of cancer patients.	24month

Collaborators and Investigators

• Sponsor: West China Hospital
• Collaborators: Jiangsu HengRui Medicine Co., Ltd.
• Investigators: Principal Investigator: qing Mao, M.D., West China Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): January 4, 2018
• Primary Completion (Anticipated): December 20, 2019
• Study Completion (Anticipated): August 1, 2020

Study Registration Dates

• First Submitted: December 19, 2017
• First Submitted That Met QC Criteria: December 26, 2017
• First Posted (Actual): January 4, 2018

Study Record Updates

• Last Update Posted (Actual): January 4, 2018
• Last Update Submitted That Met QC Criteria: December 26, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioma; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Apatinib
• Other Study ID Numbers: Ahead-G-201702

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No