Estudio de fase 2 de panitumumab más irinotecán seguido de panitumumab más AMG 479 en sujetos con carcinoma colorrectal metastásico que expresan KRAS no mutado y refractarios a oxaliplatino ?o irinotecán? y a regímenes que contienen oxaliplatino para evaluar los mecanismos de resistencia adquirida a panitumumabA Phase 2 Study of Panitumumab Plus Irinotecan Followed by Panitumumab PlusAMG 479 in Subjects With Metastatic Colorectal Carcinoma Expressing Wild Type KRAS and Refractory to Oxaliplatin- or Irinotecan- and Oxaliplatin-containing Regimens to Evaluate Mechanisms of Acquired Resistance to Panitumumab

Phase 1

• Conditions: Cáncer colorrectal metastásicoMetastatic colorectal cancer; MedDRA version: 9.1Level: LLTClassification code 10052362Term: Metastatic colorectal cancer

• Registration Number: EUCTR2008-004752-77-ES
• Lead Sponsor: Amgen Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-11-26
• Study Completion: 2013-07-22
• Last Update Posted: 2 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

? Histologically or cytologically confirmed metastatic adenocarcinoma of the colon or rectum
? Subjects with wild-type KRAS tumor status confirmed by central laboratory assessment
? Radiographic evidence of disease progression while on or ? 6 months after treatment with irinotecan- and oxaliplatin- or oxaliplatin-based chemotherapy for mCRC
? Radiographic measurement of tumor burden done within 28 days prior to Day 1 (start of treatment with investigational product)
? At least 1 uni-dimensionally measurable lesion ? 20 mm using conventional CT or MRI or ? 10 mm by spiral CT per modified RECIST. Lesion must not be chosen from a previously irradiated field, unless there has been documented disease progression in that field after irradiation and prior to enrollment. All sites of disease must be evaluated
? At least 1 tumor (metastatic lesion or unresected primary tumor) that is amenable to core needle biopsy, as determined by the clinician who will perform the biopsy
? Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (Appendix E)
? Male or female ? 18 years of age at the time of informed consent
? Willing to undergo two core biopsy procedures of tumors (metastasis or unresected primary)
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

? History of prior or concurrent central nervous system (CNS) metastases
? Prior treatment with anti-EGFR antibodies (eg, panitumumab, cetuximab) or EGFR small molecule inhibitors (eg, erlotinib, gefitinib)
? Prior treatment with monoclonal antibodies directed against IGF-1R
? Use of systemic chemotherapy and radiotherapy ? 21 days before enrollment
? Use of any antibody therapy (eg, bevacizumab) ? 42 days before enrollment
? Use of anti-tumor therapies including prior experimental agents or approved anti-tumor small molecules ? 30 days before enrollment
? Known UGT1A1 polymorphisms predisposing to increased irinotecan toxicity
? History of irinotecan intolerance that may interfere with planned treatment
? History of interstitial lung disease (eg, pneumonitis, pulmonary fibrosis) or evidence of interstitial lung disease on baseline chest computerized tomography (CT) scan
? Known positive test(s) for human immunodeficiency virus (HIV) infection, hepatitis C virus, acute or chronic active hepatitis B infection
? Any co-morbid disease or condition that could increase the risk of toxicity (eg, significant ascites, significant pleural effusion)
? Any uncontrolled concurrent illness (eg, infection, bleeding diathesis) or history of any medical condition that may interfere with the interpretation of the study results
? Major surgical procedure ? 28 days before enrollment or minor surgical procedure ? 14 days before enrollment. Subjects must have recovered from surgery related toxicities.

Study & Design

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