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A Study of Apatinib Versus Docetaxol Patients With Advanced Gastric Cancer

Primary Purpose

Gastric Carcinoma

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Docetaxel

apatinib

About this trial

This is an interventional treatment trial for Gastric Carcinoma focused on measuring Gastric Carcinoma, apatinib

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Zhongshan Hospital Affiliated to Fudan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

apatinib

Docetaxel

Arm Description

Apatinib 850 mg qd po, and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent

Docetaxel 60mg/m2 ivgtt every 3 weeks, and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Overall survival (OS)

defined as the time from randomize to death

Objective response rate (ORR)

defined as the rate of complete response and partial response according to RECIST guidelines.

Disease control rate(DCR)

defined as the rate of complete response , partial response and stable disease according to RECIST guidelines.

Quality of life(QoL)

as measured by the European Organization for Research and Treatment of Cancer questionnaire (EORTC QLQ C30)

Safety (incidence of adverse events)

incidence of adverse events

Full Information

NCT ID

NCT02409199

First Posted

March 26, 2015

Last Updated

November 17, 2015

Sponsor

Shanghai Zhongshan Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02409199

Brief Title

A Study of Apatinib Versus Docetaxol Patients With Advanced Gastric Cancer

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2015

Overall Recruitment Status

Unknown status

Study Start Date

June 2015 (undefined)

Primary Completion Date

December 2016 (Anticipated)

Study Completion Date

March 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shanghai Zhongshan Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastric Carcinoma

Keywords

Gastric Carcinoma, apatinib

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

apatinib

Arm Type

Experimental

Arm Description

Apatinib 850 mg qd po, and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent

Arm Title

Docetaxel

Arm Type

Active Comparator

Arm Description

Docetaxel 60mg/m2 ivgtt every 3 weeks, and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent

Intervention Type

Drug

Intervention Name(s)

Docetaxel

Intervention Type

Drug

Intervention Name(s)

apatinib

Primary Outcome Measure Information:

Title

Progression-free survival (PFS)

Description

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

Time Frame

Approximately 1 year

Secondary Outcome Measure Information:

Title

Overall survival (OS)

Description

defined as the time from randomize to death

Time Frame

Approximately 3 years

Title

Objective response rate (ORR)

Description

defined as the rate of complete response and partial response according to RECIST guidelines.

Time Frame

Approximately 1 year

Title

Disease control rate(DCR)

Description

defined as the rate of complete response , partial response and stable disease according to RECIST guidelines.

Time Frame

Approximately 1 year

Title

Quality of life(QoL)

Description

as measured by the European Organization for Research and Treatment of Cancer questionnaire (EORTC QLQ C30)

Time Frame

Approximately 3 years

Title

Safety (incidence of adverse events)

Description

incidence of adverse events

Time Frame

Approximately 1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Liu Tianshu, doctor

Phone

+862152303355

liu.tianshu@zs-hospital.sh.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Yu Yiyi, master

Phone

+862164041990

yu.yiyi@zs-hospital.sh.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Liu Tianshu, doctor

Organizational Affiliation

oncology department

Official's Role

Principal Investigator

Facility Information:

Facility Name

Zhongshan Hospital Affiliated to Fudan University

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Tianshu Liu, Doctor

liu.tianshu@zs-hospital.sh.cn

First Name & Middle Initial & Last Name & Degree

Yiyi yu, Master

12. IPD Sharing Statement

Learn more about this trial

A Study of Apatinib Versus Docetaxol Patients With Advanced Gastric Cancer

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