Gastric Cancer
Conditions
Keywords
Gastric Cancer, Pharmacokinetics, Dose titration
Brief summary
Apatinib dose titration in Advanced or Metastatic Gastric Cancer
Interventions
DRUGApatinib
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Dose Interruptions | 15 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE(Common Terminology Criteria for Adverse Events) v4.0 | 15 months | — |
Countries
China
Outcome results
None listed