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Phase 2
18 Years
Open (Enrolling)
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

- 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:


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:


Principal Investigator

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

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

November 2011

Completion Date:

March 2015

Related Keywords:

  • Metastatic Colorectal Cancer
  • Colorectal Neoplasms



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