Open-label, Single Arm Trial of BI 695502 in Patients With Previously Untreated Metastatic Colorectal Cancer
NCT ID: NCT02776683
Last Updated: 2019-11-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
123 participants
INTERVENTIONAL
2016-06-08
2018-10-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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All patients
BI 695502
Avastin
Interventions
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BI 695502
Avastin
Eligibility Criteria
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Inclusion Criteria
* Metastatic disease not amenable to surgical curative treatment and eligible to receive therapy with mFOLFOX6 (Leucovorin/5-Fluorouracil/Oxaliplatin) + bevacizumab.
* At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
* Adequate hepatic, renal and bone marrow function.
Exclusion Criteria
* Prior therapy with monoclonal antibodies or small molecule inhibitors against Vascular endothelial growth factor (VEGF) or VEGF receptors, including Avastin® or Avastin® biosimilar
* Previous malignancy other than Colorectal cancer (CRC) in the last 5 years except for basal cell cancer of the skin or pre-invasive cancer of the cervix
* Spinal cord compression or brain metastases unless asymptomatic, stable and not requiring steroids for at least 6 weeks prior to start of study treatment
* Any unresolved toxicity \> Common Toxicity Criteria Grade 1 (except alopecia) from previous anticancer therapy (including radiotherapy)
* History or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding
* A thrombotic or hemorrhagic event \<=6 months prior to screening (includes hemoptysis, Gastrointestinal (GI) bleeding, hematemesis, central nervous system hemorrhage, epistaxis, vaginal bleeding, cerebral infarction, transient ischemic attacks, myocardial infarction, angina, and coronary artery disease)
18 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Principal Investigators
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Boehringer Ingelheim
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
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Mayo Clinic-Arizona
Phoenix, Arizona, United States
Pacific Cancer Medical Center, Inc.
Anaheim, California, United States
The Oncology Institute of Hope and Innovation
Anaheim, California, United States
Rocky Mountain Cancer Centers
Denver, Colorado, United States
Ashland Bellefonte Cancer Center
Ashland, Kentucky, United States
University of Michigan Health System
Ann Arbor, Michigan, United States
Washington University School of Medicine
St Louis, Missouri, United States
Aultman Hospital
Canton, Ohio, United States
Oncology Hematology Care
Cincinnati, Ohio, United States
Northwest Cancer Specialists PC
Portland, Oregon, United States
Willamette Valley Cancer Institute and Research Center
Springfield, Oregon, United States
Texas Oncology, P.A.
Abilene, Texas, United States
Texas Oncology, PA,
Amarillo, Texas, United States
Texas Oncology, P.A.
Austin, Texas, United States
Texas Oncology, P.A.
Flower Mound, Texas, United States
Texas Oncology, P.A.
Garland, Texas, United States
Oncology Consultants, P.A.
Houston, Texas, United States
Texas Oncology, P.A.
McAllen, Texas, United States
Texas Oncology, PA
Mesquite, Texas, United States
Texas Oncology-San Antonio Northeast
San Antonio, Texas, United States
Texas Oncology San Antonio Medical Center
San Antonio, Texas, United States
Tyler Hematology-Oncology, PA
Tyler, Texas, United States
Texas Oncology, P.A.
Tyler, Texas, United States
Texas Oncology, P.A., Deke Slayton Cancer Center
Webster, Texas, United States
Virginia Cancer Institute
Richmond, Virginia, United States
Chiba Cancer Center
Chiba, Chiba, , Japan
National Hospital Organization Shikoku Cancer Center
Ehime, Matsuyama, , Japan
Hokkaido University Hospital
Hokkaido, Sapporo, , Japan
Japan Organization of Occupational Health and Safety Kansai Rosai Hospital
Hyogo, Amagasaki, , Japan
Kagawa University Hospital
Kagawa, Kita-gun, , Japan
Osaka University Hospital
Osaka, Suita, , Japan
Jananese Foundation for Cancer Research
Tokyo, Koto-ku, , Japan
Hospital Vall d'Hebron
Barcelona, , Spain
Hospital Duran i Reynals
L'Hospitalet de Llobregat, , Spain
Hospital Clínico de Valencia
Valencia, , Spain
CI Chernivtsi RC Oncological Dispensary Bukovinian SMU
Chernivtsi, , Ukraine
Munic.Instit."City Clin.Hosp.#4" of Dnipro City Council
Dnipropetrovsk, , Ukraine
Regional Clinical Oncological Dispensary, Ivano-Frankivsk
Ivano-Frankivsk, , Ukraine
CI of PH Kharkiv CCH #2
Kharkiv, , Ukraine
Treatment-Diagnostic CTR of Private Enterprise, Kirovohrad
Kirovohrad, , Ukraine
CI Kryvyi Rih Oncological Dispensary of DRC
Kryvyi Rih, Dnipropetrovsk, , Ukraine
National Institute of Cancer
Kyiv, , Ukraine
CI of LRC Lviv Onco.Reg.Treat.&Diag.Cent.
Lviv, , Ukraine
Poltava Regional Clinical Oncological Dispensary, Poltava
Poltava, , Ukraine
Sumy Regional Oncology Center
Sumy, , Ukraine
Vinnytsia Regional Clinical Oncological Dispensary
Vinnytsia, , Ukraine
Countries
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Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Other Identifiers
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2015-003718-25
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1302.3
Identifier Type: -
Identifier Source: org_study_id
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