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

NCT03219593 | Unknown Phase 2 DMC

• 1 other identifier: BYEC20170710
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Cancer; Apatinib; Biomarker

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Secondary Outcomes (5)

• Overall survival (OS)

  2 years

• Disease control rate (DCR)

  1 year

• Objective response rate (ORR)

  1 year

• Quality of life score (QoL)

  1 year

• Adverse Events(AEs)

  1 year

Other Outcomes (1)

• Tumor biomarkers

  Before the start of apatinib treatment

Study Arms (1)

Apatinib Group

EXPERIMENTAL

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

Drug: Apatinib mesylate tablets

Interventions

Apatinib mesylate tablets DRUG

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.

Apatinib Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Bengbu Medical University: lead

Study Sites (1)

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

Bengbu, Anhui, 233004, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

apatinib

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Qiong Wu, M.D.,Ph.D

  First Affiliated Hospital of Bengbu Medical College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yan Yang, M.D.,Ph.D

CONTACT

+86-552-3086178; qiannianhupo@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Apatinib Monotherapy

Study Record Dates

• First Submitted: July 13, 2017
• First Posted: July 17, 2017
• Study Start: September 7, 2017
• Primary Completion: August 1, 2019
• Study Completion: February 1, 2020
• Last Updated: September 11, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)