Phase III Study of Apatinib Tablets in the Treatment of Advanced or Metastatic Gastric Cancer

Advanced or Metastatic Gastric Cancer Clinical Trial

Official title:

A Randomized, Double Blinded, Placebo Controlled Multicenter Phase III Study of Apatinib Mesylate Tablets in the Treatment of Advanced or Metastatic Gastric Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01512745
• Other study ID #: HENGRUI 20101208
• Status: Completed
• Phase: Phase 3
• First received: January 13, 2012
• Last updated: April 2, 2015
• Start date: January 2011
• Est. completion date: May 2013

Study information

• Verified date: April 2015
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Apatinib is a tyrosin-inhibitor agent targeting at vascular endothelial growth factor receptor (VEGFR), and it's anti-angiogenesis effect has been viewed in preclinical tests. The investigators' phase I study has shown that the drug's toxicity is manageable and the maximum tolerable daily dose is 850 mg. The purpose of this study is to determine whether apatinib can improve progression free survival or overall survival compared with placebo in patients with metastatic gastric carcinoma who failed two lines of chemotherapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 273
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 within 1 week before randomization.

• 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

• More than 4 weeks for cytotoxic agents or growth inhibitors

• Adequate hepatic, renal, heart, and hematologic functions (HB = 90g/L,platelets > 80 ×10E+9/L, neutrophil > 1.5 × 10E+9/L, serum creatinine = 1× upper limit of normal(ULN), bilirubin < 1.25× ULN, and serum transaminase = 2.5× ULN).

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 CNS metastasis

• Intercurrence with one of the following: coronary artery disease, arrhythmia ,heart failure and proteinuria = (+)

• INR > 1.5 and APPT > 1.5 × ULN

• Abuse of alcohol or drugs

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced or Metastatic Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• apatinib
apatinib 850 mg qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
• placebo
placebo qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent

Locations

Country	Name	City	State
China	The 81 Hosiptal of PLA	Nanjing	Jiangsu
China	Fudan University cancer hospital	Shanghai	Shanghai

Sponsors (3)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.	Fudan University, The 81 Hospital of PLA

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS	Progression free survival	30 months	Yes
Primary	OS	Overall Survival	30 months	Yes
Secondary	DCR	Disease control rate	30 months	No
Secondary	ORR	objective response rate	30 months	No
Secondary	QoL	quality of life	30 months	Yes
Secondary	Toxicity		30 months	Yes