Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Stomach Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

Antineoplastic Agents

All Drugs and Chemicals

Apatinib

Protein Kinase Inhibitors

Enzyme Inhibitors

apatinib 850 mg qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent

apatinib

placebo qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent

placebo

Jin Li, MD, PHD

Shukui Qin, MD

Apatinib is a tyrosin-inhibitor agent targeting at vascular endothelial growth factor receptor (VEGFR), and it's anti-angiogenesis effect has been viewed in preclinical tests. The investigators' phase I study has shown that the drug's toxicity is manageable and the maximum tolerable daily dose is 850 mg. The purpose of this study is to determine whether apatinib can improve progression free survival or overall survival compared with placebo in patients with metastatic gastric carcinoma who failed two lines of chemotherapy.

Phase III Study of Apatinib Tablets in the Treatment of Advanced or Metastatic Gastric Cancer

A Randomized, Double Blinded, Placebo Controlled Multicenter Phase III Study of Apatinib Mesylate Tablets in the Treatment of Advanced or Metastatic Gastric Cancer

Progression free survival of All the Evaluable Participants.Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as at least a 20% increase in the sum of diameters of target lesions, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).

Disease control is defined as the proportion of patients who had a best response rating of complete response, partial response, or stable disease, and lasted at least 4 weeks.

Objective Response Rate is defined as the proportion of patients with complete response(CR) or partial response(PR)

Fudan University

The 81 Hospital of PLA

Jiangsu HengRui Medicine Co., Ltd.

apatinib: apatinib 850 mg qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent

placebo: placebo qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent

Placebo

Total

Age, Continuous

Sex: Female, Male

5 participants in the apatinib group and 1 in the placebo group withdrew from the study before receiving the assigned treatments.As a result,267 randomly assigned participants were included in Full Analysis Set （FAS），with 176 assigned to the apatinib group and 91 assigned to the placeo group.

Co-Director of Clinical Trials

Progression Free Survival(PFS)

Overall Survival(OS)

Disease Control Rate(DCR)

Objective Response Rate(ORR)

Percentage of Participants With Adverse Events

Overall Study

Carcinoma

Antibodies

Immunoglobulins

On the first day of every 3 weeks, MRG003 will be administered via intravenous infusion at 2.0 mg/kg calculated based on the actual body weight

MRG003

Program Director

Wenhua Xue, Secretary

Qingxia Fan, Doctor

Baoxia He, Director

Ying Liu, Doctor

Fang Xu, Secretary

Xinjun Liang, Doctor

Xiaoran Zhang, Secretary

Meili Sun, Doctor

Zhehai Wang, Secretary

Changzheng Li, Doctor

Aiping Zhou, Doctor

The objective of this study is to assess the safety, efficacy, pharmacokinetics, and immunogenicity of MRG003 in patients with EGFR-positive, HER2-negative, inoperable locally advanced or metastatic gastric cancer.

Approximately 6054 patients will be enrolled to evaluate the safety and preliminarily efficacy of MRG003. Patients will receive 2.0 mg/kg dose of MRG003 intravenously every 3 weeks (Q3W) and may receive up to 24 months of MRG003 if there is evidence of clinical benefit to the patients.

A Study to Evaluate the Efficacy and Safety of MRG003 in Patients With Advanced Gastric Cancer.

A Phase II Clinical Study to Evaluate the Efficacy and Safety of MRG003 in EGFR-Positive, HER2-Negative Advanced Gastric Cancer.

ORR is defined as the proportions of patients with a complete response (CR) and partial response (PR). ORR will be assessed by Independent Review Committee (IRC) according to RECIST v1.1.

Any reaction, side effect, or untoward event that occurs during the course of the clinical trial whether or not the event is considered related to the study drug.

ORR is defined as the proportions of patients with a complete response (CR) and partial response (PR). ORR will be assessed by investigator according to RECIST v1.1.

PFS is defined as the duration from the start of treatment to the onset of tumor progression or death of any cause.

DOR is defined as the duration from the initial recording of objective disease response to the first onset of tumor progression, or death of any cause.

DCR is defined as the proportions of patients achieving CR, PR, and stable disease (SD) after treatment.

OS is defined as the duration from the start of treatment to death of any cause.

Area under the curve up to the last validated measurable plasma concentration

The proportion of patients with positive ADA immunogenicity results.

Shanghai Miracogen Inc.

Liver Neoplasms

Liver Diseases

Patients receive Metatinib orally 200mg once daily (QD) or 100mg twice daily (BID) until disease progression or unacceptable toxicity occurred.

Metatinib Tromethamine

Shuangling Deng, MS

Yanhua Ding, MD

Feng Bi, MD

This is an open-label, multicenter study designed to assess the safety, tolerability, preliminary efficacy and pharmacokinetics of Metatinib Tromethamine tablet in patients with advanced or metastatic gastric cancer, liver cancer, colorectal cancer,or con squamous NSCLC. Patients receive Metatinib orally 200mg once daily (QD) or 100mg twice daily (BID) until disease progression or unacceptable toxicity occurred. The study will determine whether MET gene mutation, amplification, as well as MET protein overexpression in tumor tissue correlate with treatment efficacy and clinical outcome. The potential PD biomarker for Metatinib will also be explored.

Study of Metatinib Tromethamine Tablet

A Phase Ib Clinical Study of the Tolerance, Safety and Preliminary Efficacy Observation of Single-/Multiple- Doses of Metatinib Tromethamine Tablets in Patients With Advanced or Metastatic Solid Tumor

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Phase III Study of Apatinib Tablets in the Treatment of Advanced or Metastatic Gastric Cancer	NCT01512745	Advanced or Met...	apatinib placebo	18 Years - 70 Years	Jiangsu HengRui Medicine Co., Ltd.
A Study to Evaluate the Efficacy and Safety of MRG003 in Patients With Advanced Gastric Cancer.	NCT05188209	Advanced or Met... Advanced or Met...	MRG003	18 Years - 75 Years	Shanghai Miracogen Inc.
Study of Metatinib Tromethamine Tablet	NCT02650375	Advanced or Met... Advanced or Met... Advanced or Met... Advanced or Met...	Metatinib Trome...	18 Years - 75 Years	Jiangsu Simcere Pharmaceutical Co., Ltd.

Spots Global Cancer Trial Database for advanced or metastatic gastric cancer