A Study of Apatinib Versus Docetaxol Patients With Advanced Gastric Cancer

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

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).

Study Overview

• Status: Unknown
• Conditions: Gastric Carcinoma
• Intervention / Treatment: Drug: Docetaxel; Drug: apatinib

• Study Type: Interventional
• Enrollment (Anticipated): 66
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Zhongshan Hospital Affiliated to Fudan University

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:

• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: apatinib; Apatinib 850 mg qd po, and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent	Drug: apatinib
Active Comparator: Docetaxel; Docetaxel 60mg/m2 ivgtt every 3 weeks, and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent	Drug: Docetaxel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival (OS)	defined as the time from randomize to death	Approximately 3 years
Objective response rate (ORR)	defined as the rate of complete response and partial response according to RECIST guidelines.	Approximately 1 year
Disease control rate(DCR)	defined as the rate of complete response , partial response and stable disease according to RECIST guidelines.	Approximately 1 year
Quality of life(QoL)	as measured by the European Organization for Research and Treatment of Cancer questionnaire (EORTC QLQ C30)	Approximately 3 years
Safety (incidence of adverse events)	incidence of adverse events	Approximately 1 year

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital
• Investigators: Principal Investigator: Liu Tianshu, doctor, Oncology Department

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): March 1, 2017

Study Registration Dates

• First Submitted: March 26, 2015
• First Submitted That Met QC Criteria: April 3, 2015
• First Posted (Estimate): April 6, 2015

Study Record Updates

• Last Update Posted (Estimate): November 18, 2015
• Last Update Submitted That Met QC Criteria: November 17, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: apatinib; Gastric Carcinoma
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Protein Kinase Inhibitors; Docetaxel; Apatinib
• Other Study ID Numbers: AHEAD-G301