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A Phase 2, Open Label, Multicenter, Randomized Trial Comparing Tivozanib in Combination With mFOLFOX6 to Bevacizumab in Combination With mFOLFOX6, In Stage IV Metastatic Colorectal Cancer (mCRC) Subjects

Phase 2
18 Years
Open (Enrolling)
Colorectal Cancer

Thank you

Trial Information

A Phase 2, Open Label, Multicenter, Randomized Trial Comparing Tivozanib in Combination With mFOLFOX6 to Bevacizumab in Combination With mFOLFOX6, In Stage IV Metastatic Colorectal Cancer (mCRC) Subjects

A 2:1 randomization between tivozanib in combination with mFOLFOX6 to bevacizumab in
combination with mFOLFOX6. Subjects will be stratified by origin of cancer, Lactate
Dehydrogenase (LDH) status, and number of metastatic sites.

Inclusion Criteria:

- Documented diagnosis of metastatic colorectal cancer

- One measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

- No prior systemic chemotherapy for advanced colorectal cancer; no fluorouracil
containing adjuvant therapy in previous 6 months

- Eastern Cooperative Oncology Group (ECOG) status of 0 or 1

Exclusion Criteria:

- Any prior Vascular Endothelial Growth Factor (VEGF)-directed therapy or any other
agent or investigational agent targeting the VEGF pathway

- Primary Central Nervous System (CNS) malignancies or CNS metastases

- Hematologic abnormalities:

- Hemoglobin < 9.0 g/dL,

- ANC < 2000 per mm3,

- Platelet count < 100,000 per mm3,

- Prothrombin (PT) or Partial Thromboplastin Time (PTT) > 1.5 X Upper Limit of
Normal (ULN)

- Serum chemistry abnormalities:

- Total bilirubin > 1.5 X ULN,

- Aspartate aminotransferase (AST) or Alanine Aminotransferase (ALT) > 2.5 X

- Alkaline phosphatase > 2.5 X ULN,

- Serum albumin < 2.0 g/dL,

- Creatinine > 1.5 X ULN,

- Proteinuria > 2+ by urine dipstick

- Significant cardiovascular disease

- Significant thromboembolic or vascular disorders within 6 months prior to
administration of first dose of study drug

- Non-healing wound, bone fracture, or skin ulcer

- Inadequate recovery from any prior surgical procedure or major surgical procedure
within 8 weeks prior to administration, or anticipation of major surgical procedure
during the course of the study

- History of significant gastrointestinal (GI) toxicity, diarrhea, or stomatitis within
the last 6 weeks

- An active peptic ulcer disease, inflammatory bowel disease, ulcerative colitis, or
other gastrointestinal condition with increased risk of perforation

- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal
abscess within 4 weeks prior to administration of first dose of study drug

- Serious/active infection or infection requiring antibiotics

- Significant bleeding disorders within 6 months prior to administration of first dose
of study drug

- Active second primary malignancy, other than non-melanoma skin cancers,
non-metastatic prostate cancer, in situ cervical cancer and ductal or lobular
carcinoma in situ of the breast. Subject is not considered to have a currently active
malignancy if they have completed anti-cancer therapy and have been disease free for
> 5 years

- History of allergic reactions, or intolerance, attributed to compounds of similar
chemical or biologic composition to 5-fluorouracil, history of Grade 3
hypersensitivity to oxaliplatin, history of allergic reaction to folic acid

- Female subject is pregnant or lactating

- Known history of genetic or acquired immune suppression disease including Human
Immunodeficiency Virus (HIV); subjects on immune suppressive therapy for organ

- Inability to swallow pills, malabsorption syndrome or gastrointestinal disease, major
resection of the stomach or small bowel, or gastric bypass

- Uncontrolled neuro-psychiatric disorder or altered mental status

- Peripheral neuropathy ≥ Grade 2

- Participating in another interventional protocol

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-Free Survival (PFS) based on investigator radiological tumor assessment

Outcome Description:

The time from the date of randomization until objective tumor progression or death due to any cause. Objective tumor progression is defined by radiological assessments by the investigators.

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Medical Director

Investigator Role:

Study Director

Investigator Affiliation:

Astellas Pharma Global Development


United States: Food and Drug Administration

Study ID:




Start Date:

November 2011

Completion Date:

December 2015

Related Keywords:

  • Colorectal Cancer
  • metastatic colorectal cancer
  • Avastin
  • bevacizumab
  • tivozanib
  • mFOLFOX6
  • AV951
  • ASP4130
  • Colorectal Neoplasms



University of California San DiegoLa Jolla, California  92093
Seattle Cancer Care AllianceSeattle, Washington  98109
Arizona Clinical Research CenterTucson, Arizona  85712
Queen's Medical CenterHonolulu, Hawaii  96813
NYU Cancer InstituteNew York, New York  10016
Northwestern UniversityChicago, Illinois  60611
Cancer Care AssociatesTulsa, Oklahoma  74136
Northern Utah AssociatesOgden, Utah  84403
St. Luke's Hospital and Health NetworkBethlehem, Pennsylvania  18015
Oregon Health and Science UniversityPortland, Oregon  97201
Desert Hematology Oncology Medical Group, Inc.Rancho Mirage, California  92270
University of HawaiiHonolulu, Hawaii  96813
Investigative Clinical Research of Indiana, LLCIndianapolis, Indiana  46254
Signal Point Clinical Research Center, LLCMiddletown, Ohio  45042
Cleveland Clinic FloridaWeston, Florida  33331
Horizon Oncology Research, Inc.Lafayette, Indiana  
Banner MD Anderson Cancer CenterGilbert, Arizona  85234
Genesis Cancer CenterHot Springs, Arizona  85715
UC Irvine Medical Center, Division of Hematology/OncologyOrange, California  92868
Mountain Blue Cancer Care CenterWheat Ridge, Colorado  80033
University of Florida, Davis Cancer Center (VA)Gainesville, Florida  32610
Kaiser Foundation HospitalsHonolulu, Hawaii  96819
Illinios Cancer CarePeoria, Illinois  61615
Associates of Oncology Hematology, P.C.Rockville, Maryland  20850
University of Michigan Hospital and Health CenterAnn Arbor, Michigan  48109
Alamance Regional Medical Center Cancer CenterBurlington, North Carolina  27215
Tri Country Hematology / OncologyCanton, Ohio  44718