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
About this trial
This is an interventional treatment trial for Gastric Cancer focused on measuring Gastric Cancer, Pharmacokinetics, Dose titration
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
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
NCT ID
NCT02764268
First Posted
April 27, 2016
Last Updated
February 24, 2022
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
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
derived
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Apatinib Dose Titration in Advanced or Metastatic Gastric Cancer
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