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Phase 2
18 Years
N/A
Open (Enrolling)
Both
Metastatic Colorectal Cancer

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Trial Information


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Progression-free survival (defined as the time from randomization to the first occurrence of progression based on RECIST v1.1 criteria or death from any cause on study)

Outcome Time Frame:

Up to 24 months

Safety Issue:

No

Principal Investigator

Ina Rhee, M.D., Ph.D.

Investigator Role:

Study Director

Investigator Affiliation:

Genentech

Authority:

United States: Food and Drug Administration

Study ID:

MEF4982g

NCT ID:

NCT01399684

Start Date:

November 2011

Completion Date:

March 2015

Related Keywords:

  • Metastatic Colorectal Cancer
  • Colorectal Neoplasms

Name

Location

Hinsdale, Illinois  60521
Alexandria, Minnesota  56308
Albany, Georgia  31701
Birmingham, Alabama  35294
Phoenix, Arizona  85012
Fountain Valley, California  92708
Miami, Florida  33176
Philadelphia, Pennsylvania  19104
Denver, Colorado  
Boston, Massachusetts  
Charlotte, North Carolina  
Indianapolis, Indiana  
Washington, District of Columbia  
Las Vegas, Nevada  89109