Apatinib Dose Titration in Advanced or Metastatic Gastric Cancer

February 24, 2022 updated by: Jiangsu HengRui Medicine Co., Ltd.

Apatinib Dose Titration: Analyses of Exposure, Safety and Efficacy in Advanced or Metastatic Gastric Cancer

Apatinib dose titration in Advanced or Metastatic Gastric Cancer

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200233
        • Shanghai 6th People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. ≥ 18 and ≤ 70 years of age
  2. Histological confirmed advanced or metastatic adenocarcinoma of the stomach
  3. Have failed for at least 2 lines of chemotherapy
  4. Life expectancy of at least 12 weeks
  5. Eastern Cooperative Oncology Group Performance Status of 0 or 1
  6. At least one measurable lesion beyond stomach (larger than 10 mm in diameter by spiral CT scan)
  7. Duration from the last therapy is more than 6 weeks for nitroso or mitomycin
  8. More than 4 weeks for operation or radiotherapy or cytotoxic agents
  9. Adequate hepatic, renal, heart, and hematologic functions

Exclusion Criteria:

  1. Pregnant or lactating women
  2. History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
  3. Hypertension and unable to be controlled within normal level following treatment of anti-hypertension agents (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg)
  4. Any factors that influence the usage of oral administration
  5. Evidence of central nerves system metastasis
  6. Intercurrence with one of the following: coronary artery disease, arrhythmia ,heart failure
  7. proteinuria ≥ (+)
  8. International Normalized Ratio > 1.5 and activated partial thromboplastin time > 1.5 × Upper limit of normal（ULN）
  9. Certain possibility of gastric or intestine hemorrhage
  10. Less than 4 weeks from the last clinical trial
  11. Prior VEGFR inhibitor treatment
  12. Disability of serious uncontrolled intercurrence infection Objective evidence of previous or current pulmonary fibrosis history, interstitial pneumonia, Pneumoconiosis, radiation pneumonitis, drug-related pneumonia, Pulmonary function damaged seriously etc

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Apatinib
Drug: Apatinib

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants With Dose Interruptions
Time Frame: 15 months
15 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE(Common Terminology Criteria for Adverse Events) v4.0
Time Frame: 15 months
15 months
Objective Response Rate(ORR)
Time Frame: 15 months
Number of Participants Who Reached Complete Response and Partial Response Assessed by Recist(Response Evaluation Criteria in Solid Tumors)1.1 at the End of the Second Treatment Cycle.
15 months
Disease Control Rate(DCR)
Time Frame: 15 months
Number of Participants Who Reached Complete Response and Partial Response and Stable Disease Assessed by Recist(Response Evaluation Criteria in Solid Tumors)1.1 at the End of the Second Treatment Cycle.
15 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 2, 2016

Primary Completion (Actual)

December 10, 2018

Study Completion (Actual)

April 15, 2019

Study Registration Dates

First Submitted

April 27, 2016

First Submitted That Met QC Criteria

May 4, 2016

First Posted (Estimate)

May 6, 2016

Study Record Updates

Last Update Posted (Actual)

March 11, 2022

Last Update Submitted That Met QC Criteria

February 24, 2022

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HR-APTN-DT-AGC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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