Spots Global Cancer Trial Database for Open-label, Single Arm Trial of BI 695502 in Patients With Previously Untreated Metastatic Colorectal Cancer
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Trial Identification
Brief Title: Open-label, Single Arm Trial of BI 695502 in Patients With Previously Untreated Metastatic Colorectal Cancer
Official Title: A Single Arm, Open-label, Multicenter, Multinational, Safety and Efficacy Phase IIIb Trial of BI 695502 Plus mFOLFOX6 in Patients With Previously Untreated Metastatic Colorectal Cancer
Study ID: NCT02776683
Conditions
Study Description
Brief Summary: The objective of this trial is to evaluate the safety and tolerability of BI 695502 in combination with leucovorin/5-fluorouracil/oxaliplatin (mFOLFOX6) and as maintenance therapy (when applicable). As well as to evaluate the following efficacy parameters: Progression-free survival (PFS), objective response rate (proportion of patients with complete response \[CR\] plus partial response \[PR\]), overall survival (OS), duration of response (DOR), time to progression (TTP).
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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, Saint 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
Contact Details
Name: Boehringer Ingelheim
Affiliation: Boehringer Ingelheim
Role: STUDY_CHAIR
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