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A Phase 2, Randomized, Double Blind, Placebo Controlled Study of AMG 386 in Combination With FOLFIRI in Subjects With Previously Treated Metastatic Colorectal Carcinoma

Phase 2
18 Years
Not Enrolling
Cancer, Carcinoma, Colon Cancer, Colorectal Cancer, Gastrointestinal Cancer, Metastases, Metastatic Cancer, Metastatic Colorectal Cancer, Oncology, Rectal Cancer

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Trial Information

A Phase 2, Randomized, Double Blind, Placebo Controlled Study of AMG 386 in Combination With FOLFIRI in Subjects With Previously Treated Metastatic Colorectal Carcinoma

Inclusion Criteria:

- Histologically confirmed adenocarcinoma of the colon or rectum in patients who are
presenting with metastatic disease

- One and only one prior chemotherapy regimen for metastatic disease consisting of the
combination of a fluoropyrimidine-based chemotherapy and an oxaliplatin-based
chemotherapy. Prior adjuvant chemotherapy used prior to the onset of metastatic
disease is permitted

- At least one uni dimensionally measurable lesion per modified RECIST criteria. All
sites of disease must be evaluated <= 28 days before randomization

- Radiographically documented disease progression per modified RECIST criteria either
while receiving or <= 6 months after the last dose of prior chemotherapy regimen for
metastatic disease

- ECOG performance status of 0 or 1

- Man or woman >= 18 years of age

- Adequate end organ assessments by laboratory studies (hematological and chemistries)

- Life expectancy >= 3 months

Exclusion Criteria:

- Exclude subjects with a history of prior malignancy, except:

- Malignancy treated with curative intent and with no known active disease present
for >= 3 years before enrollment and felt to be at low risk for recurrence by
treating physician

- Adequately treated non-melanomatous skin cancer or lentigo maligna without
evidence of disease

- Adequately treated cervical carcinoma in situ without evidence of disease

- Prostatic intraepithelial neoplasia without evidence of prostate cancer

- Prior irinotecan therapy

- Systemic chemotherapy, hormonal therapy, or immunotherapy <= 21 days prior to

- Experimental or approved proteins/antibodies (eg, bevacizumab) <= 30 days prior to

- Clinically significant cardiac disease within 12 months prior to randomization,
including myocardial infarction, unstable angina, grade 2 or greater peripheral
vascular disease, cerebrovascular accident, transient ischemic attack, congestive
heart failure, or arrhythmias not controlled by outpatient medication, percutaneous
transluminal coronary angioplasty/stent

- Known allergy or hypersensitivity to irinotecan, 5 FU (known dihydropyrimidine
dehydrogenase deficiency) or leucovorin

- Active inflammatory bowel disease or other bowel disease causing chronic diarrhea
(defined as >= CTC grade 2 [CTCAE version 3.0])

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

To estimate the treatment effect as measured by progression free survival (PFS) in subjects treated with AMG 386 + FOLFIRI relative to subjects treated with FOLFIRI + placebo.

Outcome Time Frame:

The time frame will be event driven and will occur when 100 subjects have experienced a PFS event (radiographic disease progression or death).

Safety Issue:


Principal Investigator


Investigator Role:

Study Director

Investigator Affiliation:



European Union: European Medicines Agency

Study ID:




Start Date:

November 2008

Completion Date:

June 2012

Related Keywords:

  • Cancer
  • Carcinoma
  • Colon Cancer
  • Colorectal Cancer
  • Gastrointestinal Cancer
  • Metastases
  • Metastatic Cancer
  • Metastatic Colorectal Cancer
  • Oncology
  • Rectal Cancer
  • Metastatic Colorectal Cancer
  • colorectal cancer
  • colon cancer
  • Carcinoma
  • Colonic Neoplasms
  • Rectal Neoplasms
  • Colorectal Neoplasms
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary
  • Gastrointestinal Neoplasms