Phase 1
Completed N=28
Effect of Panitumumab on the Pharmacokinetics of Irinotecan
Source: ClinicalTrials.gov NCT00563316 ↗Enrolled (actual)
28
Serious AEs
14.8%
Results posted
Apr 2016
Primary outcomePrimary: Maximum Observed Plasma Concentration (Cmax) of Irinotecan — 1570; 1570 ng/mL
Summary
The primary objective of this study is to determine if panitumumab affects the pharmacokinetic (PK) profile of irinotecan.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Observed Plasma Concentration (Cmax) of Irinotecan |
1570; 1570 | — |
| PRIMARY Area Under the Plasma Concentration-time Curve From the Time of Dosing to Infinity (AUCinf) for Irinotecan |
12000; 10700 | — |
| PRIMARY Area Under the Plasma Concentration-time Curve From the Time of the Last Quantifiable Concentration (AUClast) for Irinotecan |
11900; 10600 | — |
| PRIMARY Number of Participants With Clinically Significant Adverse Events (AEs) |
27; 5; 26; 9; 26; 25 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00563316). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.