Apatinib Dose Titration in Advanced or Metastatic Gastric Cancer

Not Applicable

Completed

• Conditions: Gastric Cancer
• Interventions: Drug: Apatinib

• Registration Number: NCT02764268
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Brief Summary

Apatinib dose titration in Advanced or Metastatic Gastric Cancer

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-04
• Study First Submitted: 2016-04-27
• Study First Submitted QC: 2016-05-04
• Study First Posted: 2016-05-06
• Study Start: 2016-11-02
• Primary Completion: 2018-12-10
• Study Completion: 2019-04-15
• Last Update Submitted: 2022-02-24
• Last Update Posted: 2022-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Apatinib	Apatinib	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Dose Interruptions	15 months

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE(Common Terminology Criteria for Adverse Events) v4.0	15 months
Objective Response Rate(ORR)	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.
Disease Control Rate(DCR)	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.

Trial Locations

Locations (1)

Shanghai 6th People's Hospital; 🇨🇳 Shanghai, Shanghai, China