Status:
TERMINATED
A Study of Herceptin (Trastuzumab) in Combination With Standard Chemotherapy in Patients With HER Positive Metastatic Gastric Cancer
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Gastric Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This open-label, multi-center study will evaluate the efficacy and safety of Herceptin (trastuzumab) in combination with standard chemotherapy as first-line treatment in patients with HER2 positive me...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
June 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT01260194
Start Date
June 1 2011
End Date
January 1 2015
Last Update
November 2 2016
Active Locations (6)
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1
Bangalore, Karnataka, India, 560027
2
New Delhi, National Capital Territory of Delhi, India, 110085
3
Bangalore, India, 560029
4
Nagpur, India, 440012