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An Open-label, Randomized, Phase 3 Clinical Trial of ABX-EGF Plus Best Supportive Care Versus Best Supportive Care in Subjects With Metastatic Colorectal Cancer


Phase 3
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer, Metastases

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Trial Information

An Open-label, Randomized, Phase 3 Clinical Trial of ABX-EGF Plus Best Supportive Care Versus Best Supportive Care in Subjects With Metastatic Colorectal Cancer


Inclusion Criteria:



- Pathologic diagnosis of colorectal adenocarcinoma (diagnostic tissue obtained by
tissue biopsy)

- Metastatic colorectal carcinoma

- ECOG performance status of 0, 1 or 2

- Documented evidence of disease progression during, or following treatment, with
fluoropyrimidine, irinotecan and oxaliplatin chemotherapy for metastatic colorectal
cancer

- Radiographic documentation of disease progression during or within 6 months following
the most recent chemotherapy regimen

- Unidimensionally measurable disease

- Tumor expressing EGFr by immunohistochemistry

- At least 2 but not more than 3 prior chemotherapy regimens for colorectal cancer

- Adequate hematologic, renal and hepatic function

Exclusion Criteria:

- Symptomatic brain metastases requiring treatment

- History or evidence of interstitial pneumonitis or pulmonary fibrosis

- Use of systemic chemotherapy or radiotherapy within 30 days prior to enrollment

- Prior EGFr targeting therapies

- Prior anti-tumor therapies including prior experimental agents or approved anti-tumor
small molecules and biologics of short (less than a week) serum half life within 30
days before enrollment, or prior experimental or approved proteins within 3 months
before enrollment

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

United States: Food and Drug Administration

Study ID:

20020408

NCT ID:

NCT00113763

Start Date:

January 2004

Completion Date:

June 2009

Related Keywords:

  • Colorectal Cancer
  • Metastases
  • Metastatic Colorectal Cancer, Colon
  • Colorectal, Rectal Cancer, Cancer
  • Metastatic, EGFr, Clinical Trial
  • Panitumumab, ABX-EGF
  • Immunex, Abgenix, Amgen
  • Colorectal Neoplasms
  • Neoplasm Metastasis

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