Effect of Panitumumab on the Pharmacokinetics of Irinotecan
Completed · Phase 1
Conditions studied: Metastatic Colorectal Cancer
In brief
The primary objective of this study is to determine if panitumumab affects the pharmacokinetic (PK) profile of irinotecan.
Key facts
- Study ID
- NCT00563316
- Run by
- Amgen
- People needed
- 28
- Starts
- 2008-03-01
- Expected to finish
- 2010-06-01
- Last updated by the study team
- 2016-04-12
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Pathologically confirmed unresectable metastatic colorectal cancer (mCRC) which has progressed on at least one prior 5-fluorouracil (5FU)-containing chemotherapy regimen
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Life expectancy of ≥ 3 months as documented by the investigator
- Baseline actual body weight ≤ 160 kg
- Competent to comprehend, sign, and date a written Institutional Review Board (IRB) approved informed consent form before any study-specific procedures are performed
You may not qualify if…
- Treatment with radiotherapy ≤ 14 days before enrollment. Patients must have recovered from all radiotherapy-related toxicities
- Known presence of central nervous systems (CNS) metastases
- Any prior malignancy (except for non-melanomatous skin cancer or in situ cervical cancer) other than the study disease, unless treated with curative intent with no evidence of disease ≤ 2 years before enrollment
- History of interstitial lung disease (eg, pneumonitis or pulmonary fibrosis) or evidence of interstitial lung disease on baseline chest computed tomography (CT) scan
- Active inflammatory bowel disease or other bowel disease causing chronic diarrhea (defined as > Common Terminology Criteria for Adverse Events (CTCAE version 3) grade 2
- Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year before enrollment
- UGT1A1*28 TA7/7, TA7/8, TA8/8 genetic polymorphisms; Gilbert's Disease
- Treatment with CYP3A4 enzyme inhibiting or inducing medications ≤ 2 weeks before enrollment
- Prior anti-epidermal growth factor receptor (EGFr) antibody therapy (eg, cetuximab) or treatment with small molecule EGFr inhibitors (eg, gefitinib, erlotinib, lapatinib)
- Systemic chemotherapy, hormonal therapy, immunotherapy, or experimental or approved proteins/antibodies (eg, bevacizumab) ≤ 30 days before enrollment
- Subjects requiring immunosuppressive agents (eg, methotrexate and cyclosporine), however corticosteroids are allowed
- Major surgery < 28 days prior to enrollment or minor surgery (excluding catheter placement) < 14 days before enrollment
Where it is running
- Research Site — Philadelphia, Pennsylvania, United States
- Research Site — Philadelphia, Pennsylvania, United States
- Research Site — Nashville, Tennessee, United States
- Research Site — Nashville, Tennessee, United States
- Research Site — Vancouver, British Columbia, Canada
- Research Site — Vancouver, British Columbia, Canada
- Research Site — Toronto, Ontario, Canada
- Research Site — Toronto, Ontario, Canada
- Research Site — Billings, Montana, United States
- Research Site — Billings, Montana, United States
- Research Site — Chapel Hill, North Carolina, United States
- Research Site — Chapel Hill, North Carolina, United States
Full record on ClinicalTrials.gov
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