Ph2 Biomarker (Mechanism of K-ras Dependency) in Wt KRAS Metastatic Colorectal Cancer Patients

Phase 1

• Conditions: Metastatic colorectal cancer; MedDRA version: 15.1Level: LLTClassification code 10052362Term: Metastatic colorectal cancerSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06-30
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• Histologically or cytologically confirmed metastatic adenocarcinoma of the colon or rectum
• Wild-type KRAS tumor status of archival tumor tissue (preferably from the primary tumor) confirmed by an Amgen approved central laboratory or an experienced laboratory (local laboratory) per local regulatory guidelines using a validated test method
• Radiographic evidence of disease progression while on or = 6 months after treatment with irinotecan- and oxaliplatin- or oxaliplatin-based chemotherapy for mCRC
• Subjects in whom relapse is diagnosed within 6 months after completing adjuvant chemotherapy (with oxaliplatin-containing regimen) will be considered as having failed a prior regimen for metastatic disease.
• 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 38
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 37

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 or small molecule inhibitors directed against IGF-1R
• Use of systemic chemotherapy and radiotherapy = 21 days before enrollment Subject must have recovered from acute toxicities related to radiotherapy.
• 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. Core biopsy, central venous catheter placement, fine needle aspiration, thoracentesis, or paracentesis is not considered a major or minor surgical procedure.

Study & Design

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