Clinical trial NCT02764268: 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
Overall status: COMPLETED
Phase: NA
Conditions: Gastric Cancer
Keywords: Gastric Cancer
Pharmacokinetics
Dose titration
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-05-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Apatinib dose titration in Advanced or Metastatic Gastric Cancer


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Dose Interruptions
timeFrame: 15 months
Secondary outcomes:
measure: Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE(Common Terminology Criteria for Adverse Events) v4.0
timeFrame: 15 months
measure: Objective Response Rate(ORR)
timeFrame: 15 months
measure: Disease Control Rate(DCR)
timeFrame: 15 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai 6th People's Hospital
state: Shanghai
Study officials:
References:
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.