Apatinib Versus Placebo as a Third Line Treatment in Patients With Advanced or Metastatic Gastric Cancer

Gastric Carcinoma Clinical Trial

Official title:

A Randomized Phase 2/3 Study of Apatinib as Third Line Treatment in Patients With Metastatic Gastric Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00970138
• Other study ID #: 2009APA-MGC
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 1, 2009
• Last updated: July 11, 2011
• Start date: June 2009
• Est. completion date: December 2010

Study information

• Verified date: September 2010
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• 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 compared with placebo in patients with metastatic gastric carcinoma who failed two lines of chemotherapy.

Description:

Up to now, although FU based, cisplatin based and taxane based regimen, and ECF regimen have been suggested as the first line therapy for A/MGC by FDA, the efficacy of these treatment is still unsatisfied for their toxicity and limitation in prolonging survival. Based on the promising results of apatinib in the phase I study, this clinical trial has been designed to evaluate whether apatinib can improve progression free survival in patients with metastatic gastric carcinoma who failed two lines of chemotherapy compared with placebo. Patients will be randomized to 3 groups, one group patients will receive the treatment of apatinib 850mg qd, one group patients will receive apatinib 425mg bid, and the other group will receive placebo.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 141
• Est. completion date: December 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• = 18 and = 70 years of age

• Histologically confirmed advanced or metastatic adenocarcinoma of the stomach

• Have failed for 2 lines of chemotherapy

• Life expectancy of more than 3 months

• ECOG performance scale = 2

• At least one measurable lesion (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 (platelets > 80 × 109/L, neutrophil > 2.0 × 109/L, serum creatinine = 1.5mg/dl, total bilirubin within upper limit of normal(ULN), and serum transaminase=2.5×the 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

• Any factors that influence the usage of oral administration; Evidence of CNS metastasis

• History of another malignancy within the last five years except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix

• Intercurrence with one of the following: hypertension, coronary artery disease, arrhythmia and heart failure

• Receiving the therapy of thrombolysis or anticoagulation

• Abuse of alcohol or drugs

• Allergy to the ingredient of the agent or more than two kinds of food and drug

• Less than 4 weeks from the last clinical trial

• Disability of serious uncontrolled intercurrence infection.

Study Design

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

Related Conditions & MeSH terms

• Gastric Carcinoma
• Stomach Neoplasms

Intervention

Drug:
• apatinib tablet
A850: apatinib 850 mg qd p.o. plus placebo qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent B425: apatinib 425 mg bid p.o. until disease progression or intolerable toxicity or patients withdrawal of consent Cpla: placebo bid p.o. until disease progression or intolerable toxicity or patients withdrawal of consent

Locations

Country	Name	City	State
China	Fudan University Cancer Hospital	ShangHai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival		8 weeks	Yes
Secondary	Overall survival safety		8 weeks	Yes
Secondary	DCR (Disease control rate)		8 weeks	No
Secondary	ORR (Objective response rate)		8 weeks	No
Secondary	QoL (Quality of life)		8 weeks	Yes
Secondary	Toxicity		8 weeks	Yes