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

Metastatic Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00327119
• Other study ID #: 20050216
• Status: Completed
• Phase: Phase 2
• First received: May 16, 2006
• Last updated: September 11, 2009
• Start date: April 2006

Study information

• Verified date: September 2009
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

Drug:
• ABX-EGF (panitumumab)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

References & Publications (1)

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. doi: 10.1093/jjco — View Citation

External Links

•   AmgenTrials clinical trials website