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Evaluation of Customized Treatment According to BRCA1 Assessment in Patients With Advanced Gastric Cancer


Phase 2/Phase 3
18 Years
N/A
Not Enrolling
Both
Advanced Gastric Cancer

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Trial Information

Evaluation of Customized Treatment According to BRCA1 Assessment in Patients With Advanced Gastric Cancer


Inclusion Criteria:



- Provision of informed consent

- Female or male aged 18 years and over

- Histologic or cytologic confirmation of advanced gastric cancer

- Stage III-IV (AJCC 7th)

- ECOG: 0-2

- Have tumor sample that can be tested for BRCA1 mRNA expression

- Negative pregnancy test for women of childbearing potential

- Neutrophile granulocyte greater than 1.5×10^9/L

- Hemoglobin greater than 10g/dL

- Platelet greater than 100×10^9/L

- Serum bilirubin not greater than 1.5x upper limit of reference range (ULRR)

- ALT or AST not greater than 1.5x ULRR

- Creatinine clearance no less than 60ml/min

Exclusion Criteria:

- Have at least another primary malignant tumor

- Active infection

- Chemotherapy with experimental drug within 3 weeks before the start of study therapy

- Women who are pregnant or breast feeding

- Weight loss greater 10% within 6 weeks before the start of study therapy

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free Survival

Outcome Time Frame:

12 months

Safety Issue:

No

Principal Investigator

Baorui Liu, MD, PHD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Drum Tower Hospital, Nanjing University Medical School

Authority:

China: Food and Drug Administration

Study ID:

BREC-AGC

NCT ID:

NCT01206218

Start Date:

October 2010

Completion Date:

Related Keywords:

  • Advanced Gastric Cancer
  • Gastric Cancer, BRCA1
  • Stomach Neoplasms

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