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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02409199
Other study ID # AHEAD-G301
Secondary ID
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


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
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