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

NCT03390062 | Unknown Phase 2

• 1 other identifier: Ahead-G-201702
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Glioma

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Objective Response Rate(ORR)

  6month

• EORTC QLQ-C30

  24month

Study Arms (1)

apatinib

EXPERIMENTAL

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

Drug: Apatinib

Interventions

Apatinib DRUG

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.

Also known as: Aitan

apatinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Age ≥ 18 years old, male or female;
• \. 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;
• \. ECOG score: 0-2 points;
• \. 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;
• \. No history of mental illness in patients;
• \. Thyroid function is normal;
• \. Subjects volunteered to join the study, signed informed consent, good compliance, with follow-up.

You may not qualify if:

• \. Pregnant or lactating women;
• \. 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;
• \. Unable to swallow, chronic diarrhea and intestinal obstruction, significantly affect the medication and absorption;
• \. Have a clear gastrointestinal bleeding concerns (such as local active ulcer lesions, fecal occult blood ++ above), within 6 months history of gastrointestinal bleeding;
• \. Have mental illness, or history of substance abuse;
• \. 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);

Sponsors & Collaborators

• West China Hospital: lead
• Jiangsu HengRui Medicine Co., Ltd.: collaborator

MeSH Terms

Conditions

Glioma

Interventions

apatinib

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• qing Mao, M.D.

  West China Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ping Li, M.D.

CONTACT

08618980602780; lipinglunwen@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: December 19, 2017
• First Posted: January 4, 2018
• Study Start: January 4, 2018
• Primary Completion: December 20, 2019
• Study Completion: August 1, 2020
• Last Updated: January 4, 2018

Record last verified: 2017-12