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Safety and efficacy of the addition of simvastatin to cetuximab in k-ras mutant advanced or metastatic colorectal cancer patients. A single-arm, multicenter, phase II study using a Simon two stage design. - RASTAT-C

Safety and efficacy of the addition of simvastatin to cetuximab in k-ras mutant advanced or metastatic colorectal cancer patients. A single-arm, multicenter, phase II study using a Simon two stage design. - RASTAT-C

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2009-017384-42-NL
Enrollment
Unknown
Registered
2010-02-08
Start date
2010-05-17
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

k-ras mutant advanced or metastatic colorectal cancer failing prior 5-FU, oxaliplatin, and irinotecan containing regimens. MedDRA version: 12.1 Level: LLT Classification code 10061451 Term: Colorectal cancer

Interventions

Trade Name: Cetuximab Product Name: Erbitux Pharmaceutical Form: Intravenous infusion Trade Name: simvastatin Product Name: simvastatin Pharmaceutical Form: Coated tablet

Sponsors

Academisch ziekenhuis Leiden acting under the name of Leids Universitair Medisch Centrum
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Advanced or metastatic colorectal cancer failing prior 5FU, oxaliplatin and irinotecan containing regimens - Mutation in codon 12, 13, or 61 of the k-ras gene on tumor sample - Adequate condition (WHO 0-2) - Adequate organ function - Written informed consent - Age = 18 years - Progressive disease in the past 3 months Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Prior EGFr inhibiting therapy - Symptomatic brain metastasis - Using verapamil, amiodarone or drodarone - Symptomatic hypothyroidism - History of severe pulmonary disease - History of toxicity during statin use

Design outcomes

Primary

MeasureTime frame
Main Objective: To investigate the efficacy of the addition of simvastatin to cetuximab in k-ras mutant advanced or metastatic colorectal cancer patients.;Secondary Objective: To investigate OS, PFS, ORR, and safety of simvastatin combined with cetuximab in k-ras mutant advanced or metastatic colorectal cancer patients.;Primary end point(s): To investigate the percentage of patients with k-ras mutant advanced or metastatic colorectal cancer free from progression (according to RECIST 1.1) and alive after 12.5 weeks of the first dose of cetuximab (i.e., 14 weeks after the scan at baseline at start of simvastatin) in the presence of simvastatin.—

Countries

Netherlands

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026