Panitumumab DDI Irinotecan

This study has been completed.
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00563316
First received: November 21, 2007
Last updated: July 7, 2011
Last verified: July 2011
  Purpose

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%.


Condition Intervention Phase
Metastatic Colorectal Cancer
Drug: Panitumumab
Drug: Irinotecan
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Amgen:

Enrollment: 28
Study Start Date: January 2008
Study Completion Date: March 2011
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Panitumumab DDI
This is a single arm PK study of panitumumab and irinotecan.
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.
Other Name: Vectibix
Drug: 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.
Other Name: Camptosar

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00563316

Locations
United States, Montana
Research Site
Billings, Montana, United States
United States, North Carolina
Research Site
Chapel Hill, North Carolina, United States
United States, Pennsylvania
Research Site
Philadelphia, Pennsylvania, United States
United States, Tennessee
Research Site
Nashville, Tennessee, United States
Canada, British Columbia
Research Site
Vancouver, British Columbia, Canada
Canada, Ontario
Research Site
Toronto, Ontario, Canada
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00563316     History of Changes
Other Study ID Numbers: 20062010
Study First Received: November 21, 2007
Last Updated: July 7, 2011
Health Authority: Canada: Health Canada
Canada: Institutional Review Board
United States: Food and Drug Administration
United States: Institutional Review Board
United States: Quorom Institutional Review Board

Keywords provided by Amgen:
colorectal cancer
chemotherapy
cancer
metastatic
irinotecan
EGFr
epidermal growth factor

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases
Antibodies, Monoclonal
Irinotecan
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses
Topoisomerase I Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on October 20, 2014