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An Open-label, Multicentre Phase IV Study of Trastuzumab in Combination With the Standard Therapy (as Per Routine Clinical Practice) as First-line Therapy in Patients With HER2 Positive Metastatic Gastric Cancer


Phase 4
18 Years
N/A
Open (Enrolling)
Both
Gastric Cancer

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Trial Information

An Open-label, Multicentre Phase IV Study of Trastuzumab in Combination With the Standard Therapy (as Per Routine Clinical Practice) as First-line Therapy in Patients With HER2 Positive Metastatic Gastric Cancer


Inclusion Criteria:



- Adult patients, >/=18 years of age

- Histologically confirmed adenocarcinoma of the stomach or gastro-esophageal junction
with advanced or metastatic disease, not amenable to curative therapy

- Measurable disease, according to the Response Evaluation Criteria in Solid Tumors
(RECIST)

- HER2 positive tumor (primary tumor or metastasis

- ECOG Performance status 0, 1 or 2

- Life expectancy of at least 3 months

Exclusion Criteria:

- Previous chemotherapy for advanced or metastatic disease less than 6 month before
study start

- Lack of physical integrity of the upper gastrointestinal tract or malabsorption
syndrome (patients with partial or total gastrectomy are allowed to participate in
the study)

- Patients with active (significant or uncontrolled) gastrointestinal bleeding

- Residual relevant toxicity resulting from previous chemotherapy

- Other malignancy within the last 5 years (except carcinoma in situ of the cervix, or
basal cell carcinoma)

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Median progression free survival according to tumor assessments

Outcome Time Frame:

2.5 years

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

India: Drug Controller General

Study ID:

ML25477

NCT ID:

NCT01260194

Start Date:

June 2011

Completion Date:

August 2018

Related Keywords:

  • Gastric Cancer
  • Stomach Neoplasms

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