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Phase 3
18 Years
N/A
Open (Enrolling)
Both
Gastric Cancer

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Trial Information


Inclusion Criteria:



- Adult patients, >/= 18 years of age

- Histologically confirmed adenocarcinoma of the stomach or gastro-esophageal junction

- Metastatic disease involving at least 2 organs (at least liver or lung or both)

- HER2-positive primary or metastatic tumor

- Adequate renal function

- Eastern Cooperative Oncology Group (ECOG) performance status 2

Exclusion Criteria:

- Previous chemotherapy for locally advanced or metastatic disease

- Prior gastrectomy (partial or total) for the underlying malignant disease under
investigation

- Prior therapy with an anti-HER2 agent and/or platinum-based chemotherapeutic agent

- Lack of physical integrity of the upper gastrointestinal tract or malabsorption
syndrome

- Current gastrointestinal bleeding

- Other malignancy within the last 5 years, except for carcinoma in situ of the cervix
or squamous cell carcinoma of the skin

- History of clinically significant cardio-vascular disease or disorder

- Chronic high-dose corticosteroid therapy

- History or clinical evidence of brain metastases

- Pregnant women

- Active infection with HIV, hepatitis B, hepatitis C, or HIV-positive

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Overall survival

Outcome Time Frame:

approximately 8 years

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

United States: Food and Drug Administration

Study ID:

BO27798

NCT ID:

NCT01450696

Start Date:

December 2011

Completion Date:

June 2020

Related Keywords:

  • Gastric Cancer
  • Stomach Neoplasms

Name

Location

Fountain Valley, California  92708
Albany, New York  12208
Kansas City, Kansas  66160
Eugene, Oregon  
Indianapolis, Indiana  
Charleston, South Carolina