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


Phase 3
18 Years
70 Years
Open (Enrolling)
Both
Advanced or Metastatic Gastric Cancer

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Trial Information

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


Inclusion Criteria:



- ≥ 18 and ≤ 70 years of age

- Histological 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 ≤ 1

- 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 (platelets > 80 × 109/L,
neutrophil > 1.5 × 109/L, serum creatinine ≤ 1X 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

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

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

- INR > 1.5 and APPT > 1.5 X 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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

PFS

Outcome Description:

Progression free survival

Outcome Time Frame:

8 weeks

Safety Issue:

Yes

Principal Investigator

jin Li, MD, PHD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fudan University

Authority:

China: Food and Drug Administration

Study ID:

HENGRUI 20101208

NCT ID:

NCT01512745

Start Date:

January 2011

Completion Date:

June 2012

Related Keywords:

  • Advanced or Metastatic Gastric Cancer
  • Stomach Neoplasms

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