Multicenter Phase II study to evaluate efficacy and safety of combination therapy with trastuzumab and pertuzumab in patients with HER2-positive metastatic colorectal cancer
Phase 2
- Conditions
- colorectal cancer
- Registration Number
- JPRN-UMIN000027887
- Lead Sponsor
- ational Cancer Center Hospital East
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
Not provided
Exclusion Criteria
1)Has a known history of bone marrow transplantation or organ transplantation 2)Has a positive result on the serum pregnancy test 3)Is judged by the investigator to be inappropriate for study participation for any reason.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Confirmed objective response rate (ORR) by investigators' assessment
- Secondary Outcome Measures
Name Time Method - Progression-free survival (PFS) - Duration of response (DoR) - Time to treatment failure (TTF) - Disease control rate (DCR) - Overall survival (OS) - Confirmed ORR by central assessment - Incidences of adverse events - ORR and PFS in the previous regimens containing an anti-EGFR monoclonal antibody (cetuximab or panitumumab)