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

Glioma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03390062
• Other study ID #: Ahead-G-201702
• Status: Not yet recruiting
• Phase: Phase 2
• First received: December 19, 2017
• Last updated: December 26, 2017
• Start date: January 4, 2018
• Est. completion date: August 1, 2020

Study information

• Verified date: December 2017
• Source: West China Hospital
• Contact: ping Li, M.D.
• Phone: 08618980602780
• Email: lipinglunwen[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: August 1, 2020
• Est. primary completion date: December 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glioma

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
West China Hospital	Jiangsu HengRui Medicine Co., Ltd.

Outcome

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