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Apatinib Dose Titration in Advanced or Metastatic Gastric Cancer

Primary Purpose

Gastric Cancer

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Apatinib
Sponsored by
Jiangsu HengRui Medicine Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring Gastric Cancer, Pharmacokinetics, Dose titration

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shanghai 6th People's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Apatinib

Arm Description

Outcomes

Primary Outcome Measures

Number of Participants With Dose Interruptions

Secondary Outcome Measures

Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE(Common Terminology Criteria for Adverse Events) v4.0
Objective Response Rate(ORR)
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.
Disease Control Rate(DCR)
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.

Full Information

First Posted
April 27, 2016
Last Updated
February 24, 2022
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02764268
Brief Title
Apatinib Dose Titration in Advanced or Metastatic Gastric Cancer
Official Title
Apatinib Dose Titration: Analyses of Exposure, Safety and Efficacy in Advanced or Metastatic Gastric Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
November 2, 2016 (Actual)
Primary Completion Date
December 10, 2018 (Actual)
Study Completion Date
April 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Apatinib dose titration in Advanced or Metastatic Gastric Cancer

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
Gastric Cancer, Pharmacokinetics, Dose titration

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Apatinib
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Apatinib
Primary Outcome Measure Information:
Title
Number of Participants With Dose Interruptions
Time Frame
15 months
Secondary Outcome Measure Information:
Title
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE(Common Terminology Criteria for Adverse Events) v4.0
Time Frame
15 months
Title
Objective Response Rate(ORR)
Description
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.
Time Frame
15 months
Title
Disease Control Rate(DCR)
Description
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.
Time Frame
15 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ≥ 18 and ≤ 70 years of age Histological confirmed advanced or metastatic adenocarcinoma of the stomach Have failed for at least 2 lines of chemotherapy Life expectancy of at least 12 weeks Eastern Cooperative Oncology Group Performance Status of 0 or 1 At least one measurable lesion beyond stomach (larger than 10 mm in diameter by spiral CT scan) Duration from the last therapy is more than 6 weeks for nitroso or mitomycin More than 4 weeks for operation or radiotherapy or cytotoxic agents Adequate hepatic, renal, heart, and hematologic functions Exclusion Criteria: Pregnant or lactating women History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix 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) Any factors that influence the usage of oral administration Evidence of central nerves system metastasis Intercurrence with one of the following: coronary artery disease, arrhythmia ,heart failure proteinuria ≥ (+) International Normalized Ratio > 1.5 and activated partial thromboplastin time > 1.5 × Upper limit of normal（ULN） Certain possibility of gastric or intestine hemorrhage Less than 4 weeks from the last clinical trial Prior VEGFR inhibitor treatment 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
Facility Information:
Facility Name
Shanghai 6th People's Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200233
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36330490
Citation
Wang Y, Wang C, Zhang Y, Hao J, Yang N, Wang J, Peng M, Liu T, Zhang G, Zhan X, Zeng S, Zhang Y, Gao Y, Yao Y. Multiple-dose up-titration study to evaluate the pharmacokinetics, safety and antitumor activity of apatinib in advanced gastric adenocarcinoma. Front Oncol. 2022 Oct 18;12:876899. doi: 10.3389/fonc.2022.876899. eCollection 2022.
Results Reference
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Apatinib Dose Titration in Advanced or Metastatic Gastric Cancer

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