Status:
COMPLETED
Study to Evaluate Mechanisms of Acquired Resistance to Panitumumab
Lead Sponsor:
NantBioScience, Inc.
Conditions:
Metastatic Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study is designed to evaluate the mechanism(s) of resistance to the anti-epidermal growth factor receptor (EGFR) antibody panitumumab given in combination with irinotecan in metastatic colorectal...
Detailed Description
In Part 1, all participants will undergo a baseline tumor biopsy and will receive panitumumab with irinotecan. Participants who respond or have stable disease will continue to receive treatment until ...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed metastatic adenocarcinoma of the colon or rectum;
- Subjects with wild-type KRAS tumor status confirmed by an Amgen approved central laboratory assessment or an experienced local laboratory assessment of archival tumor tissue (preferably from the primary tumor);
- Radiographic evidence of disease progression while on or ≤ 6 months after completion of 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 computed tomography (CT) or magnetic resonance imaging (MRI) or ≥ 10 mm by spiral CT scan per modified RECIST v1.0. 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 (preferably a metastasis or unresected primary tumour) that is amenable to core biopsy, as determined by the clinician who will perform the biopsy;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- A life expectancy estimate of ≥ 3 months;
- Willing to undergo two serial core biopsy procedures of tumors (metastasis or unresected primary);
- other criteria may apply
Exclusion
- History of other primary cancer, unless:
- Malignancy treated with curative intent and with no known active disease present for ≥ 3 years before enrollment and felt to be at low risk for recurrence by the treating physician,
- Adequately treated non-melanomatous skin cancer or lentigo maligna without evidence of disease,
- Adequately treated cervical carcinoma in situ without evidence of disease,
- Prostatic intraepithelial neoplasia without evidence of prostate cancer;
- History of prior or concurrent central nervous system (CNS) metastases;
- Prior treatment with anti-EGFR (eg, panitumumab, cetuximab or small molecule inhibitors (eg, erlotinib, gefitinib);
- Prior treatment with monoclonal antibodies directed against insulin-like growth factor-1 receptor (IGF-1R) or small molecule inhibitors directed against IGF-1R;
- Use of systemic chemotherapy or radiotherapy ≤ 21 days before enrollment. Subjects must have recovered from acute toxicities related to radiotherapy;
- Use of any antibody therapy (eg, bevacizumab) ≤ 42 days before enrolment;
- Use of anti-tumor therapies including prior experimental agents or approved anti-tumor small molecules ≤ 30 days before enrolment;
- Known allergy or hypersensitivity to any component of panitumumab, irinotecan, or AMG 479;
- Known uridine diphosphate glucuronosyltransferase 1A1 (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 CT scan;
- Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year before enrolment;
- Active inflammatory bowel disease or other active bowel disease causing chronic diarrhea (defined as ≥ grade 2 per Common Terminology Criteria for Adverse Events (CTCAE) version 3.0);
- Known positive test(s) for human immunodeficiency virus (HIV) infection, hepatitis C virus, acute or chronic active hepatitis B infection;
- 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; - Other investigational procedures or drugs (ie, participation in another clinical study) ≤ 30 days before enrolment;
- other criteria may apply
Key Trial Info
Start Date :
May 5 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 22 2013
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT00891930
Start Date
May 5 2009
End Date
July 22 2013
Last Update
July 17 2024
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