A Study Evaluating the Efficacy and Safety of MEGF0444A Dosed to Progression in Combination With Bevacizumab and Folfox in Patients With Previously Untreated Metastatic Colorectal Cancer (CONGO)



Status:Completed
Conditions:Colorectal Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:6/3/2016
Start Date:November 2011
End Date:February 2014

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A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of MEGF0444A Dosed to Progression in Combination With Bevacizumab and Folfox in Patients With Previously Untreated Metastatic Colorectal Cancer

This is a Phase II, multicenter, randomized, double-blind, placebo-controlled trial designed
to estimate the efficacy of MEGF0444A treatment to disease progression, combined with
mFOLFOX-6 + bevacizumab therapy in patients with metastatic colorectal cancer (mCRC).


Inclusion Criteria:

- ECOG performance status of 0 or 1

- Adequate hematologic and end organ function

- For female patients of childbearing potential and male patients with partners of
childbearing potential, agreement to use a highly effective form of contraception and
to continue its use for 6 months after the last dose of bevacizumab or
MEGF0444A/placebo

- Negative serum pregnancy test within 7 days prior to starting study treatment in
premenopausal women and women < 2 years after the onset of menopause

Exclusion Criteria:

- Any prior systemic therapy (including chemotherapy, antibody therapy, tyrosine kinase
inhibitors, radiotherapy, immunotherapy, hormonal therapy or investigational therapy)
before Day 1 of Cycle 1 for treatment of mCRC

- Malignancies other than CRC within 5 years prior to randomization, except for those
with a negligible risk of metastasis or death

- Radiotherapy to any site for any reason within 28 days prior to Day 1 of Cycle 1

- Clinically detectable third-space fluid collections that cannot be controlled by
drainage or other procedures prior to study entry

- Treatment with any other investigational agent or participation in another clinical
trial with therapeutic intent within 28 days prior to Day 1 of Cycle 1

- Lactating women

- Clinically suspected or confirmed CNS metastases or carcinomatous meningitis

- Active infection requiring IV antibiotics

- Active autoimmune disease that is not controlled by nonsteroidal anti-inflammatory
drugs, inhaled corticosteroids, or the equivalent of ⿤ 10 mg/day prednisone

- Known clinically significant liver disease, including active viral, alcoholic, or
other hepatitis, or cirrhosis
We found this trial at
22
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Port Saint Lucie, FL
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Birmingham, AL
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Boston, MA
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Durham, NC
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Fullerton, CA
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Indianapolis, IN
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San Luis Obispo, California 93405
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Washington,
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