An Open-label Phase II Clinical trial of Panitumumab in Combination with Irinotecan for Patients with Advanced Metastatic Colorectal Cancer without KRAS mutation (Wild type) in third line chemotherapy (Patients pretreated with FOLFOX or XELOX ± bevacizumab and irinotecan alone or FOLFIRI or CAPIRI ± bevacizumab) - PIMABI

Phase 1

• Conditions: histologically confirmed Metastatic colorectal adenocarcinoma; MedDRA version: 9.1Level: PTClassification code 10052358Term: Colorectal cancer metastatic

• Registration Number: EUCTR2007-004806-28-FR
• Lead Sponsor: GERCOR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-01-31
• Study Completion: 2012-06-30
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 69

Inclusion Criteria

•Histologically confirmed metastatic adenocarcinoma of the colon or rectum by the Investigator.
•Wild Type KRAS (no mutation) by allelic discrimination on tumor DNA
•Prior chemotherapy regimens for mCRC with oxaliplatin and Fluorpyrimidines (5FU/FA or capecitabine) ± Bevacizumab and Irinotecan alone or in association with Fluorpyrimidines (5FU/FA or capecitabine) ± Bevacizumab
•At least 1 uni-dimensionally measurable lesion of at least 10 mm per modified-RECIST criteria (All sites must be evaluated = 28 days prior to the enrolment).
•Prior radiotherapy is acceptable. It must be at least 14 days since administration of radiation therapy and all signs of early toxicity must have abated.
•World Health Organisation (WHO) performance status of 0, 1 or 2

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

•Significant cardiovascular disease including unstable angina or myocardial infarction within 6 months before initiating study treatment or a history of ventricular arrhythmia (treated or not)
•Presence of KRAS mutation by allelic discrimination on tumor DNA
•Prior anti-EGFr antibody therapy (eg, cetuximab) or treatment with small molecule EGFr tyrosine kinase inhibitors (eg, erlotinib). Subjects who discontinue their first dose of anti-EGFR therapy (cetuximab) because of an infusion reaction may participate in this clinical trial.
•Prior radiotherapy within 14 days since administration of radiation therapy to enrollment. All signs of early toxicity must have abated.
•Metastases of the central nervous system
•Pregnancy ; breast feeding

Study & Design

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