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Apatinib as the First-Line Therapy in Elderly Locally Advanced or Metastatic Gastric Cancer

Primary Purpose

Gastric Cancer, Apatinib, Biomarker

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Apatinib mesylate tablets

About this trial

This is an interventional treatment trial for Gastric Cancer

Eligibility Criteria

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

Inclusion Criteria:

Patients with histologically proven primary locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma;
Age ≥ 65 years;
ECOG Performance Status: 0-2;
No previous anti-cancer therapy for the locally advanced or metastatic disease;
Unable or unwilling to chemotherapy;
At least one measurable lesion as defined by RECIST 1.1;
With acceptable hematologic, cardiac, hepatic, pulmonary and renal function;
Can take apatinib orally;
Life Expectancy: 3 months or more.

Exclusion Criteria:

History of other primary malignancy (except basal cell skin cancer or cervical carcinoma in situ);
Patients with un-controlled blood pressure on medication (> 140/90 mmHg);
Patients with other nonmeasurable disease such as un-controlled diabetes, severe cardiovascular and cerebrovascular diseases;
Patients with bleeding tendency, receiving thrombolytics or anticoagulants；
Patients with massive hydrothorax or ascites;
Patients with uncontrolled central nervous system (CNS) metastases;
Proteinuria 2+ or 24-hour urinary protein ≥ 1g;
History of drug addiction or abuse;
Patients cannot take apatinib orally for any reason;
Estimated life expectancy ˂ 3 months;
Current, recent (within 4 weeks prior to study entry), or planned participation in any other clinical trials;
Inability to understand and agree to informed consent.

Sites / Locations

Department of Medical Oncology, First Affiliated Hospital of Bengbu Medical CollegeRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Apatinib Group

Arm Description

take apatinib orally (500mg/d, once a day, continuously)

Outcomes

Primary Outcome Measures

Progression-free survival (PFS)

PFS was defined to be the time from registration to the date of disease progression or death resulting from any cause.

Secondary Outcome Measures

Overall survival (OS)

OS was defined to be the time from registration to the date of death resulting from any cause or the last contact.

Disease control rate (DCR)

DCR was defined as the proportion of patients who achieved complete response (CR ), partial response (PR) and stable disease (SD) for at least 8 weeks.

Objective response rate (ORR)

ORR was defined as the proportion of eligible patients who achieved a confirmed CR or PR by RECIST 1.1 criteria evaluated by the investigators.

Quality of life score (QoL)

QoL is a questionnaire developed to assess the quality of life of cancer patients.

Adverse Events(AEs)

AEs are evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events v4.0.

Full Information

NCT ID

NCT03219593

First Posted

July 13, 2017

Last Updated

September 7, 2017

Sponsor

First Affiliated Hospital Bengbu Medical College

1. Study Identification

Unique Protocol Identification Number

NCT03219593

Brief Title

Apatinib as the First-Line Therapy in Elderly Locally Advanced or Metastatic Gastric Cancer

Official Title

A Prospective Study of the Efficacy and Safety of Apatinib Monotherapy as First-Line Treatment in Elderly Patients With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

September 2017

Overall Recruitment Status

Unknown status

Study Start Date

September 7, 2017 (Actual)

Primary Completion Date

August 2019 (Anticipated)

Study Completion Date

February 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

First Affiliated Hospital Bengbu Medical College

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The study is to investigate the efficacy and safety of apatinib for the first-fine treatment in elderly patients with locally advanced or metastatic adenocarcinoma of stomach or gastroesophageal junction, unable or unwilling to chemotherapy, through progression-free survival (PFS). Apatinib will be given to patients with an efficacy assessment of stable disease (SD), partial response (PR), or complete response (CR) every 2 cycles. Patients were assigned to 500 mg/d apatinib continually until disease progression or intolerable toxicity or patients withdrawal of consent. The dose of apatinib may be decreased to 250 mg/d following the occurrence of a clinically significant adverse event (AE). Treatment will be discontinued if the subject is unable to tolerate a daily dose of 250 mg, and the sample size is about 30 individuals. Tumor tissue samples will be collected from each enrolled subjects before the start of treatment, and detected using next generation sequencing (NGS)-based comprehensive genomic profiling. The potential biomarkers in predicting apatinib efficacy or safety will be explored.

6. Conditions and Keywords

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

Gastric Cancer, Apatinib, Biomarker

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Model Description

Apatinib Monotherapy

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Apatinib Group

Arm Type

Experimental

Arm Description

take apatinib orally (500mg/d, once a day, continuously)

Intervention Type

Drug

Intervention Name(s)

Apatinib mesylate tablets

Intervention Description

Apatinib is taken 500 mg every day orally, half hour after breakfast with warm water. The drug is taken 4 weeks one cycle until disease progression or intolerable toxicity or death. The dose of the study drug may be decreased to 250 mg/d following the occurrence of a clinically significant adverse event (AE). Treatment will be discontinued if the subject is unable to tolerate a daily dose of 250 mg.

Primary Outcome Measure Information:

Title

Progression-free survival (PFS)

Description

PFS was defined to be the time from registration to the date of disease progression or death resulting from any cause.

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Overall survival (OS)

Description

OS was defined to be the time from registration to the date of death resulting from any cause or the last contact.

Time Frame

2 years

Title

Disease control rate (DCR)

Description

DCR was defined as the proportion of patients who achieved complete response (CR ), partial response (PR) and stable disease (SD) for at least 8 weeks.

Time Frame

1 year

Title

Objective response rate (ORR)

Description

ORR was defined as the proportion of eligible patients who achieved a confirmed CR or PR by RECIST 1.1 criteria evaluated by the investigators.

Time Frame

1 year

Title

Quality of life score (QoL)

Description

QoL is a questionnaire developed to assess the quality of life of cancer patients.

Time Frame

1 year

Title

Adverse Events(AEs)

Description

AEs are evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events v4.0.

Time Frame

1 year

Other Pre-specified Outcome Measures:

Title

Tumor biomarkers

Description

Tumor tissue samples will be applied to next generation sequencing (NGS) detection to reveal any gene variation through comprehensive genomic profiling.

Time Frame

Before the start of apatinib treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with histologically proven primary locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma; Age ≥ 65 years; ECOG Performance Status: 0-2; No previous anti-cancer therapy for the locally advanced or metastatic disease; Unable or unwilling to chemotherapy; At least one measurable lesion as defined by RECIST 1.1; With acceptable hematologic, cardiac, hepatic, pulmonary and renal function; Can take apatinib orally; Life Expectancy: 3 months or more. Exclusion Criteria: History of other primary malignancy (except basal cell skin cancer or cervical carcinoma in situ); Patients with un-controlled blood pressure on medication (> 140/90 mmHg); Patients with other nonmeasurable disease such as un-controlled diabetes, severe cardiovascular and cerebrovascular diseases; Patients with bleeding tendency, receiving thrombolytics or anticoagulants； Patients with massive hydrothorax or ascites; Patients with uncontrolled central nervous system (CNS) metastases; Proteinuria 2+ or 24-hour urinary protein ≥ 1g; History of drug addiction or abuse; Patients cannot take apatinib orally for any reason; Estimated life expectancy ˂ 3 months; Current, recent (within 4 weeks prior to study entry), or planned participation in any other clinical trials; Inability to understand and agree to informed consent.

Central Contact Person:

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

Yan Yang, M.D.,Ph.D

Phone

+86-552-3086178

qiannianhupo@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Qiong Wu, M.D.,Ph.D

Organizational Affiliation

First Affiliated Hospital of Bengbu Medical College

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Medical Oncology, First Affiliated Hospital of Bengbu Medical College

City

Bengbu

State/Province

Anhui

ZIP/Postal Code

233004

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yan Yang, M.D., Ph.D.

Phone

+86-552-3086178

qiannianhupo@163.com

First Name & Middle Initial & Last Name & Degree

Qiong Wu, M.D., Ph.D.

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Apatinib as the First-Line Therapy in Elderly Locally Advanced or Metastatic Gastric Cancer

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