A Phase 2 Study of Panitumumab Plus Irinotecan Followed by Panitumumab Plus AMG 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 - 20070820

Amgen Inc.0 个研究点目标入组 76 人开始时间: 2009年4月17日最近更新: 2021年12月21日

适应症

试验速览

暂无简介。

•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 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

•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.

发起方

Amgen Inc.