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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2009-014452-30-NL
Enrollment
Unknown
Registered
2009-10-29
Start date
2010-03-29
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 5FU, oxaliplatin and irinotecan containing regimens MedDRA version: 12.0 Level: LLT Classification code 10010036 Term: Colorectal carcinoma

Interventions

Trade Name: Panitumumab Product Name: vectibix 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 Mutation in codon 12, 13 or 61 of 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 or amiodaron Symptomatic hypothyroidism History of interstitial lung disease History of toxicity during statin use

Design outcomes

Primary

MeasureTime frame
Main Objective: To investigate the efficacy of the combination of of the addition of simvastatin to panitumumab 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 11 weeks after the first dose of panitumumab (i.e., 12.5 weeks after the scan at baseline at start of simvastatin) in the presence of simvastatin.;Secondary Objective: to investigate OS, ORR, PFS, and safety of simvastatin combined with panitumumab in k-ras mutant advanced or metastatic colorectal cancer patients. Exploratory endpoints are to investigate the role of cholesterol as a possible biomarker during this treatment and whether PTEN, PIK3CA, b-raf, ERK, and MEK status correlate with response to panitumumab in this population. Single nucleotide polymorphisms will also be assessed to investigate their possible relation with response to panitumumab.—

Countries

Netherlands

Outcome results

None listed

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