Panitumumab DDI Irinotecan

Metastatic Colorectal Cancer Clinical Trial

Official title:

A Phase I, Open-label Study to Determine the Effect of Panitumumab on the Pharmacokinetics of Irinotecan in Subjects With Unresectable Metastatic Colorectal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00563316
• Other study ID #: 20062010
• Status: Completed
• Phase: Phase 1
• First received: November 21, 2007
• Last updated: July 7, 2011
• Start date: January 2008
• Est. completion date: March 2011

Study information

• Verified date: July 2011
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaCanada: Institutional Review BoardUnited States: Food and Drug AdministrationUnited States: Institutional Review BoardUnited States: Quorom Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to determine if panitumumab affects the pharmacokinetic (PK) profile of irinotecan. The hypothesis is panitumumab does not affect the PK of irinotecan. This will be concluded if the 90% confidence intervals of the ratio of geometric means for the Cmax and AUC for irinotecan with and without concomitant panitumumab administration fall inside the interval of 70-143%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: March 2011
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Pathologically confirmed unresectable 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 IEC/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 CT scan

• Active inflammatory bowel disease or other bowel disease causing chronic diarrhea (defined as > CTC grade 2 [CTCAE version 3])

• 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-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

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

Drug:
• Panitumumab
The first infusion of panitumumab will occur on Cycle 1 Day 4. On Cycle 2 Day 1, panitumumab will be administered on the same day as irinotecan and every 2 weeks thereafter.
• Irinotecan
The first infusion of irinotecan will occur on Cycle 1 Day 1. Irinotecan will be administered on the same day as panitumumab on Cycle 2 Day 1 and every 2 weeks thereafter.

Locations

Country	Name	City	State
Canada	Research Site	Toronto	Ontario
Canada	Research Site	Vancouver	British Columbia
United States	Research Site	Billings	Montana
United States	Research Site	Chapel Hill	North Carolina
United States	Research Site	Nashville	Tennessee
United States	Research Site	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Canada, 

External Links

•   AmgenTrials clinical trials website