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Simvastatin + Panitumumab in KRAS Mutant mCRC
NCT01110785Phase 2
Key facts
- Status
- Unknown
- Start
- Apr 2010
- Primary completion
- Apr 2012
- Countries
- 1
- Sponsor
- Leiden University Medical Center
- Modality
- Small Molecules
- Drugs
- simvastatin
- Conditions
- colorectal cancer (CRC)
01
Overview
Phase 2, open-label, single-arm trial of simvastatin in colorectal cancer (CRC), sponsored by Leiden University Medical Center. Primary endpoint: Progression-Free Survival Rate at 11 weeks. Status: unknown.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Simvastatin + Panitumumab
Simvastatin oral daily + Panitumumab IV every 2 weeks
03
Who it enrols
Patients with KRAS mutant (codon 12, 13, or 61) advanced or metastatic colorectal cancer who have failed prior fluorouracil, oxaliplatin, and irinotecan regimens.
04
Endpoints
Primary
Progression-Free Survival Rate
Secondary
Toxicity
Overall Survival
Progression-Free Survival
Objective Response Rate
Correlation between skin toxicity and response
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