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

• Conditions: k-ras mutant advanced or metastatic colorectal cancer failing prior 5FU, oxaliplatin and irinotecan containing regimens; MedDRA version: 12.0Level: LLTClassification code 10010036Term: Colorectal carcinoma

• Registration Number: EUCTR2009-014452-30-NL
• Lead Sponsor: Academisch ziekenhuis Leiden acting under the name of Leids Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10-29
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

Prior EGFr inhibiting therapy
Symptomatic brain metastasis
Using verapamil or amiodaron
Symptomatic hypothyroidism
History of interstitial lung disease
History of toxicity during statin use

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified