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 |
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).
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
sites
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