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Phase 2 Study of ABX-EGF (Panitumumab) in Japanese Subjects With M-colorectal Cancer

This study has been completed.
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00327119
First received: May 16, 2006
Last updated: September 11, 2009
Last verified: September 2009
History of Changes

May 16, 2006
September 11, 2009
April 2006
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Complete list of historical versions of study NCT00327119 on ClinicalTrials.gov Archive Site
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Phase 2 Study of ABX-EGF (Panitumumab) in Japanese Subjects With M-colorectal Cancer
A Phase 2 Multicenter Single Arm Clinical Trial of ABX EGF (Panitumumab) Monotherapy in Japanese Subjects With Metastatic Colorectal Cancer Who Developed Progressive Disease or Relapsed While on or After Prior Fluoropyrimidine, Irinotecan and Oxaliplatin Chemotherapy

The primary objective of this study is to assess the effect of treatment with ABX-EGF on best overall objective response rate by modified RECIST (confirmed complete or partial response) in Japanese subjects with metastatic colorectal cancer.
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Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Metastatic Colorectal Cancer
Drug: ABX-EGF (panitumumab)
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Muro K, Yoshino T, Doi T, Shirao K, Takiuchi H, Hamamoto Y, Watanabe H, Yang BB, Asahi D. A phase 2 clinical trial of panitumumab monotherapy in Japanese patients with metastatic colorectal cancer. Jpn J Clin Oncol. 2009 May;39(5):321-6. Epub 2009 Mar 14.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
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Inclusion Criteria:

  • Metastatic colorectal adenocarcinoma;
  • Subjects must have become refractory to treatment or unable to continue treatment due to toxicity or other reasons during or after treatment with fluoropyrimidine, irinotecan and oxaliplatin for metastatic colorectal cancer including those who relapsed during or within 6 months from the completion of adjuvant therapy using the above agents; - Tumor expressing EGFr levels by immunohistochemistry (membrane staining must be positive in 1% of evaluated tumor cells).

Exclusion Criteria:

  • Subjects who have prior experimental or approved antibodies (eg, bevacizumab) within 3 months before enrollment;
  • Subjects who have prior EGFr targeting agents;
  • Chemotherapy other than fluoropyrimidine (including oral agents such as UFT, TS-1), irinotecan, and oxaliplatin (or raltitrexed) for colorectal carcinoma in accordance with specified regimens (leucovorin and levamisole are not considered as chemotherapy
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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NCT00327119
20050216
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Global Development Leader, Amgen Inc.
Amgen
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Study Director: MD Amgen
Amgen
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP