Apatinib Dose Titration in Advanced or Metastatic Gastric Cancer

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02764268
• Other study ID #: HR-APTN-DT-AGC
• Status: Completed
• Phase: N/A
• Start date: November 2, 2016
• Est. completion date: April 15, 2019

Study information

• Verified date: April 2016
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Apatinib dose titration in Advanced or Metastatic Gastric Cancer

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 15, 2019
• Est. primary completion date: December 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• Apatinib

Locations

Country	Name	City	State
China	Shanghai 6th People's Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Dose Interruptions		15 months
Secondary	Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE(Common Terminology Criteria for Adverse Events) v4.0		15 months
Secondary	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.	15 months
Secondary	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.	15 months