A Study of Apatinib Versus Docetaxol Patients With Advanced Gastric Cancer

Gastric Carcinoma Clinical Trial

Official title:

A Randomized, Multicenter Study To Evaluate The Efficacy And Safety Of Apatinib Versus Docetaxel In Patients With Previously Treated Locally Advanced Or Metastatic Gastric Cancer, Including Adenocarcinoma Of The Gastroesophageal Junction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02409199
• Other study ID #: AHEAD-G301
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: March 26, 2015
• Last updated: November 17, 2015
• Start date: June 2015
• Est. completion date: March 2017

Study information

• Verified date: November 2015
• Source: Shanghai Zhongshan Hospital
• Contact: Liu Tianshu, doctor
• Phone: +862152303355
• Email: liu.tianshu[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This multicenter, randomized study will evaluate the efficacy and safety of apatinib compared to docetaxel treatment in patients with advanced gastric cancer. At the start of the trial, patients will be randomized to one treatment arm: Arm A: apatinib 850mg qd every 3 weeks; Arm B: docetaxel 60mg/m2 every 3 weeks. Tumor assessment will be done every 8 weeks according to RECIST 1.1. The primary endpoint is progression free survival (PFS).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: March 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients, aged =18 years;

• Histologically confirmed advanced or metastatic adenocarcinoma of gastric cancer(AGC) , including adenocarcinoma of the gastroesophageal junction ;

• At least one measurable and evaluable disease based on response evaluation criteria in solid tumors (RECIST v1.1);

• Patients must have received one prior chemotherapy regimen for AGC;First-line therapy must have included a combination of at least a platinum-based treatment given concurrently, and must have experienced disease progression during or after first-line therapy for their disease;

• Eastern Cooperative Oncology Group(ECOG) performance status of 0 or 1;

• Life expectancy of more than 3 months;

• Duration from the last therapy is more than 6 weeks for nitroso or mitomycin, More than 4 weeks for other cytotoxic agents, operation or radiotherapy;

• Adequate hepatic, renal, heart, and hematologic functions ( hemoglobin= 90g/L, platelets = 80 × 109/L, neutrophil =1.5 × 109/L, serum creatinine= 1.5mg/dl, total bilirubin =1.5 ×ULN, and serum transaminase=2.5×ULN);

Exclusion Criteria:

• Pregnant or lactating women;

• History of other malignancies except cured basal cell carcinoma of skin and carcinoma insitu of uterine cervix;

• Prior chemotherapy regimen have included taxane (docetaxel or paclitaxel); Uncontrolled hypertension;

• Intercurrence with one of the following: coronary artery disease, arrhythmia and heart failure;

• Urine protein>grade 1;

• Any factors that influence the usage of oral administration;

• patients with a clear tendency of gastrointestinal bleeding;

• Abnormal coagulation function(INR=1.5, APTT=1.5 ULN);

• Abuse of alcohol or drugs;

• Less than 4 weeks from the last clinical trial;

• Prior treatment with antivascular endothelial growth factor or the other anti angiogenesis therapy;

• Evidence of central nervous system(CNS) metastasis;

• Disability of serious uncontrolled intercurrence infection.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Carcinoma
• Stomach Neoplasms

Intervention

Drug:
• Docetaxel

• apatinib

Locations

Country	Name	City	State
China	Zhongshan Hospital Affiliated to Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival (PFS)	defined as the time from randomize to progression or death; RECIST guidelines were used to define all responses after patients had received every 8 weeks of therapy	Approximately 1 year	No
Secondary	Overall survival (OS)	defined as the time from randomize to death	Approximately 3 years	No
Secondary	Objective response rate (ORR)	defined as the rate of complete response and partial response according to RECIST guidelines.	Approximately 1 year	No
Secondary	Disease control rate(DCR)	defined as the rate of complete response , partial response and stable disease according to RECIST guidelines.	Approximately 1 year	No
Secondary	Quality of life(QoL)	as measured by the European Organization for Research and Treatment of Cancer questionnaire (EORTC QLQ C30)	Approximately 3 years	Yes
Secondary	Safety (incidence of adverse events)	incidence of adverse events	Approximately 1 year	Yes