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
1 other identifier
interventional
66
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 26, 2015
CompletedFirst Posted
Study publicly available on registry
April 6, 2015
CompletedStudy Start
First participant enrolled
June 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2017
CompletedNovember 18, 2015
November 1, 2015
1.5 years
March 26, 2015
November 17, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Overall survival (OS)
Approximately 3 years
Objective response rate (ORR)
Approximately 1 year
Disease control rate(DCR)
Approximately 1 year
Quality of life(QoL)
Approximately 3 years
Safety (incidence of adverse events)
Approximately 1 year
Study Arms (2)
apatinib
EXPERIMENTALApatinib 850 mg qd po, and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
Docetaxel
ACTIVE COMPARATORDocetaxel 60mg/m2 ivgtt every 3 weeks, and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
Interventions
Eligibility Criteria
You may qualify if:
- 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);
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Zhongshan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, 200032, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Liu Tianshu, doctor
oncology department
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medicine-Oncology Derpartment of Zhongshan hospital
Study Record Dates
First Submitted
March 26, 2015
First Posted
April 6, 2015
Study Start
June 1, 2015
Primary Completion
December 1, 2016
Study Completion
March 1, 2017
Last Updated
November 18, 2015
Record last verified: 2015-11