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GI-4000 + Bevacizumab + Chemo in Ras+ mCRC
NCT01322815Phase 2
Key facts
- Status
- Terminated
- Start
- Oct 2010
- Primary completion
- Sep 2014
- Countries
- 1
- Sponsor
- Georgetown University
- Modality
- Vaccines & Immunotherapeutics
- Drugs
- GI-4000
- Conditions
- colorectal cancer (CRC)
01
Overview
Phase 2, open-label trial of GI-4000 in colorectal cancer (CRC) (2 arms), sponsored by Georgetown University. Primary endpoint: Number of Participants Alive and Free of Progression at 10 months. Started Oct 2010; status: terminated.
02
Design
2 arms- Study design
- Non-randomizedOpen-label
Chemotherapy and GI-4000
Newly diagnosed patients receiving GI-4000 + Bevacizumab + FOLFOX/FOLFIRI followed by maintenance.
GI-4000 and bevacizumab
Previously treated patients receiving GI-4000 + Bevacizumab maintenance.
03
Who it enrols
Patients with Ras-mutant metastatic colorectal cancer, either newly diagnosed (Group A) or with stable disease after first-line therapy (Group B).
04
Endpoints
Primary
Number of Participants Alive and Free of Progression
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