Status:
COMPLETED
A Study of Pertuzumab in Combination With Trastuzumab and Chemotherapy in Patients With HER2-Positive Advanced Gastric Cancer
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Gastric Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This randomized, multicenter, open-label study will evaluate two different doses of pertuzumab in combination with Herceptin (trastuzumab) and chemotherapy in the first-line treatment of participants ...
Eligibility Criteria
Inclusion
- Adult participants, greater than or equal to (\>=) 18 of age
- Adenocarcinoma of the stomach or gastroesophageal junction with inoperable locally advanced or metastatic disease, not amenable to curative therapy
- Measurable disease, according to the Response Evaluation Criteria in Solid Tumors (RECIST), v1.1
- HER2-positive tumor
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Life expectancy of at least 3 months
Exclusion
- Previous chemotherapy for advanced or metastatic disease (except (prior adjuvant or neoadjuvant therapy at least 6 months before enrollment in the study)
- Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome
- Active (significant or uncontrolled) gastrointestinal bleeding
- Abnormal laboratory values
Key Trial Info
Start Date :
December 6 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2017
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01461057
Start Date
December 6 2011
End Date
October 31 2017
Last Update
August 9 2018
Active Locations (24)
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1
Cliniques Universitaires St-Luc
Brussels, Belgium, 1200
2
UZ Leuven Gasthuisberg
Leuven, Belgium, 3000
3
Masaryk Memorial Cancer Institute; Oncological Clinic
Brno, Czechia, 656 53
4
Fakultni Nemocnice Hradec Kralove; Dept of Radiotherapy & Oncology
Hradec Králové, Czechia, 500 05