A Study of Herceptin (Trastuzumab) in Combination With Standard Chemotherapy in Patients With HER Positive Metastatic Gastric Cancer
NCT ID: NCT01260194
Last Updated: 2016-11-02
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE4
4 participants
INTERVENTIONAL
2011-06-30
2015-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
trastuzumab [Herceptin]
Loading dose of 8 mg/kg on day 1, followed by 6 mg/kg intravenous infusion every 3 weeks until disease progression in combination with standard chemotherapy
Interventions
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trastuzumab [Herceptin]
Loading dose of 8 mg/kg on day 1, followed by 6 mg/kg intravenous infusion every 3 weeks until disease progression in combination with standard chemotherapy
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Bangalore, Karnataka, India
New Delhi, National Capital Territory of Delhi, India
Bangalore, , India
Nagpur, , India
Noida, , India
Vishakpatnam, , India
Countries
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Other Identifiers
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ML25477
Identifier Type: -
Identifier Source: org_study_id