Trial Condition(s):
Study of Modified FOLFOX6 plus or minus Sorafenib in Stage IV metastatic colorectal carcinoma (mCRC) subjects
13162
Not Available
To determine if sorafenib when added to chemotherapy will slow disease progression more than chemotherapy alone in patients previously untreated for metastatic colorectal cancer.
- Histological confirmation of adenocarcinoma of the colon or rectum - Tumor tissue sample available for KRAS and BRAF assessment - Measurable metastatic Stage IV disease including at least one measurable lesion that has not previously been radiated - No prior chemotherapy for metastatic CRC - Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 - Life expectancy of at least 12 weeks - Adequate bone marrow, liver, and renal function; adequate clotting parameters
- Prior treatment with sorafenib - Clinical or radiographic evidence of brain metastasis - Major surgery, surgical biopsy, or significant traumatic injury within 28 days of randomization; evidence or history of bleeding diathesis or coagulopathy - Red blood cell (RBC), white blood cell (WBC), or platelet transfusions and/or growth factor use within 28 days before randomization - Adjuvant therapy for CRC (Stage I, II, or III) completed within 12 months before randomization - Serious, non-healing wound, ulcer, or bone fracture; Grade 3 or 4 hemorrhage within 28 days before randomization - Use of anticoagulation therapy (low dose anticoagulation therapy to mitigate risk of thrombosis due to placement of a semi-permanent central venous port for administration of chemotherapy is allowed. The use of coumadin and related compounds is excluded.) - Uncontrolled hypertension (systolic blood pressure > 150 mmHg or diastolic pressure > 100 mmHg on repeated measurement) despite optimal medical management - Thrombolic, embolic, venous, or arterial events (eg, cerebrovascular accident, including transient ischemic attacks) within 6 months before randomization - Active cardiac disease including: -- Congestive heart failure -- Unstable angina or myocardial infarction within the 6 months before randomization -- Cardiac ventricular arrhythmias requiring antiarrhythmic treatment - Peripheral neuropathy > Grade 1 (CTCAE) - Known HIV infection or chronic hepatitis B or C infection - Any active infection >/= Grade 2 (CTCAE) - Any medical, psychological, or social condition that may interfere with the subject's participation in the study or evaluation of the study results - Use of any investigational drug within 28 days or 5 half-lives of that drug, whichever is longer, before randomization - Subjects with metastatic CRC who are currently candidates for surgery with curative intent
Locations | Status | |
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Locations Cancer Research UK - Glasgow Glasgow, United Kingdom, G61 1BD | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Aberdeen Royal Infirmary Aberdeen, United Kingdom, AB25 2ZN | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Nottingham City Hospital Nottingham, United Kingdom, NG5 1PB | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Mount Vernon Hospital Northwood, United Kingdom, HA6 2RN | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Bristol Haematology and Oncology Centre Bristol, United Kingdom, BS2 8ED | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Princess Royal Hospital Hull, United Kingdom, HU8 9HE | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Queen's University Belfast, United Kingdom, BT7 1NN | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Via Christi Regional Medical Center Wichita, United States, 67214 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Uniwersyteckie Centrum Kliniczne Gdansk, Poland, 80-952 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Wojskowy Instytut Medyczny Warszawa, Poland, 04-141 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations POZ nr 1 Szpitala Uniwersyteckiego Krakow, Poland, 31-501 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Wojewodzki Szpital Zespolony Elblag, Poland, 82-300 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dolnoslaskie Centrum Onkologii Wroclaw, Poland, 53-413 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations ASL TO/2 - Piemonte Torino, Italy, 10153 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. Integrata Verona Verona, Italy, 37134 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Clínico Universitario de Valencia Valencia, Spain, 46010 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Universitario Virgen del Rocío Sevilla, Spain, 41013 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Regional Carlos Haya Málaga, Spain, 29010 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Universitario "Marqués de Valdecilla" Santander, Spain, 39008 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ciutat Sanitària i Universitària de Bellvitge L'Hospitalet de Llobregat, Spain, 08907 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Universitari Son Espases Palma de Mallorca, Spain, 07010 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Clínic i Provincial de Barcelona Barcelona, Spain, 08036 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Institut Català d'Oncologia L'Hospitalet de Llobregat, Spain, 08907 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hôpital Erasme/Erasmus Ziekenhuis BRUXELLES - BRUSSEL, Belgium, 1070 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations ZNA Middelheim ANTWERPEN, Belgium, 2020 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations UZ Gent GENT, Belgium, 9000 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Petz Aladar Megyei Korhaz Gyor, Hungary, 9024 | Status Terminated | Contact Us: E-mail: c[email protected] Phone: Not Available |
Locations University of Debrecen Medical&Health Science Center Debrecen, Hungary, 4032 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Bacs-Kiskun Country Hospital Kecskemet, Hungary, 6000 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Szegedi Tudomanyegyetem, SZAOTE Szeged, Hungary, 6720 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Christie Hospital Manchester, United Kingdom, M20 4BX | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Freeman Hospital Newcastle Upon Tyne, United Kingdom, NE7 7DN | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Queen Alexandra Hospital Portsmouth, United Kingdom, PO6 3LY | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University College London Hospitals London, United Kingdom, WC1E 6BT | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Royal Liverpool University Hospital Liverpool, United Kingdom, L7 8XP | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Lahey Clinic Medical Center Burlington, United States, 01805 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hematology and Oncology Specialists, LLC Metairie, United States, 70006 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Mary Crowley Medical Research Center Dallas, United States, 75246 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Medical Oncology/Hematology Associates Brockton, United States, 02301 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centrum Onkologii - Instytut im. M.Sklodowskiej-Curie Warszawa, Poland, 02-781 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Bialostockie Centrum Onkologii im. M. Sklodowskiej-Curie Bialystok, Poland, 15-027 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centrum Onkologii Instytut im. M. Sklodowskiej-Curie Krakow, Poland, 31-115 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations ZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii Olsztyn, Poland, 10-228 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Szpital Morski im. PCK Gdynskie Centrum Onkologii Gdynia, Poland, 81-519 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Oncology Research Center & Treatment Medical Center Ekaterinburg, Russia, 620036 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Railways Hospital named after Semashko Moscow, Russia, 129128 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Regional Oncology Center Chelyabinsk, Russia, 454087 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Research Institute of Oncology Rostov-on-Don, Russia, 350086 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations City Clinical Oncology Center St. Petersburg, Russia, 197022 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinical Oncology Center Magnitogorsk, Russia, 455001 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Krasnodar Region Oncology Centre Krasnodar, Russia, 350040 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Regional Oncology Center St. Petersburg, Russia, 191104 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinical Oncology Center Arkhangelsk, Russia, 163045 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kursk Regional Oncology Center Kursk, Russia, 305035 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Regional Oncology Center Irkutsk, Russia, 664035 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Oncology Center no 2 Sochi, Russia, 354057 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinical Oncologz Center Samara, Russia, 443031 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinical Oncology Center no 1 Volgograd, Russia, 400138 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Central Clinical Hospital Moscow, Russia, 121356 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations State Medical Institution Tula Regional Oncology Center Tula, Russia, 300053 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations IRCCS A.O.U. San Martino – IST Ist. Nazionale Ricerca Cancro Genova, Italy, 16132 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. Santa Maria Misericordia UD Udine, Italy, 33100 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations AULSS 08 Asolo - Veneto Castelfranco Veneto, Italy, 31033 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. Santa Maria degli Angeli Pordenone, Italy, 33170 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations AUSL 6 Palermo - Sicilia Palermo, Italy, 90146 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations ASUR Marche ZT09 Macerata Macerata, Italy, 62100 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ciutat Sanitària i Universitaria de la Vall d'Hebron Barcelona, Spain, 08035 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Universitario 12 de Octubre Madrid, Spain, 28041 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Althaia, Xarxa Assistencial de Manresa Manresa, Spain, 08240 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Instituto Valenciano de Oncología Valencia, Spain, 46009 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations UZ Leuven Gasthuisberg LEUVEN, Belgium, 3000 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations CHC LIEGE, Belgium, 4000 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Institut Jules Bordet/Jules Bordet Instituut BRUXELLES - BRUSSEL, Belgium, 1000 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations ZNA Middelheim ANTWERPEN, Belgium, 2020 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Szent Margit Hospital Budapest, Hungary, 1032 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Novosibirsk State-Funded Medical Institution Novosibirsk, Russia, 630047 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Medical Care Unit N 122 St. Petersburg, Russia, 194291 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ivanovo Regional Oncology Center Ivanovo, Russia, 153013 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Lugansk Regional Oncology Center Lugansk, Ukraine, 91047 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Regional Oncology Center Uzhgorod , Ukraine, 88014 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Regional Public Institution, Krivoy Rog Oncology Center Krivoy Rog, Ukraine, 50048 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Lviv State Regional Diagnostics and TreatmentOncology Center Lviv, Ukraine, 79031 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Donetsk Regional Oncological Center Regional Antitumor Cente Donetsk, Ukraine, 83092 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations National Cancer Institute Kiev, Ukraine, 03022 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kharkov Regional Oncology Center Kharkov, Ukraine, 61070 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dnepropetrovsk Regional Oncology Center Dnipropetrovsk, Ukraine, 49055 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Mariupol City Interdistrict Oncology Center Mariupol, Ukraine, 87500 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Medical Oncology Center Iasi, Romania, 700106 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Bajcsy Zsilinszky Hospital Budapest, Hungary, 1106 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Fejer megyei Szent Gyorgy Korhaz Szekesfehervar, Hungary, 8000 | Status Terminated | Contact Us: E-mail: clinical-tri[email protected] Phone: Not Available |
Locations Fovarosi Szent Laszlo Korhaz Budapest, Hungary, 1097 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Russian Oncological Scientific Center n.a. N.N. Blokhin RAMS Moscow, Russia, 115478 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinical Oncology Hospital Yaroslavl, Russia, 150054 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Medical Radiol. Research Centre of Minzdravsocrazvitie, FGBU Obninsk, Russia, 249036 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinical Oncology Center Ulyanovsk, Russia, 432063 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinical Oncology Center Izhevsk, Russia, 426009 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Komi Republican Oncology Center Syktyvkar, Russia, 167904 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations City Hospital no 9 St. Petersburg, Russia, 197110 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Pjatigorsk Affiliate of Stavropol Clinical Oncology Center Pjatygorsk, Russia, 357502 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinical Oncology Dispensary Kazan, Russia, 420029 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinical Oncology Center Vladimir , Russia, 600020 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Petrov Research Instutute of Oncology St. Petersburg, Russia, 198255 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Regional Oncologz Center Astrakhan, Russia, 414041 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Institutul Oncologic "Prof. Dr. Ioan Chiricuta" Cluj-Napoca, Romania, 400015 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Spitalul de urgenta "Sf. Ioan Cel Nou" Suceava, Romania, 720237 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Fundeni Clinical Institute Bucharest, Romania, 022326 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Alba Iulia Emergency Country Hospital Alba Iulia, Romania, 510039 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Federal State Institution Nizhny Novgorod, Russia, 603001 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Territorial Clinical Center of Oncology Khabarovsk, Russia, 680022 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations City General Hosp #4, Dnepropetrovsk State Medical Academy Dnepropetrovsk, Ukraine, 49102 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ivano-Frankovsk Regional Oncology Center MU Ivano-Frankovsk, Ukraine, 76000 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Communal establishment "Cherkassy Regional Oncology Center" Cherkassy, Ukraine, 18009 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sumy Regional Oncology Center Sumy, Ukraine, 40005 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Oncomed SRL Timisoara, Romania, 300239 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Meditech SRL Craiova-Dolj, Romania, 200535 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations OradeaCountry Emergency Clinical Hospital Oradea, Romania, 410032 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Emergency Country Hospital Baia Mare "Dr. Constantin Opris" Baia Mare, Romania, 430031 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Oncomed SRL Timisoara, Romania, 300239 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Prof. Dr. Alexandru Trestioreanu Institute of Oncology Bucharest, Romania, 022328 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Phase 2b, DB, Randomized Study Evaluating Efficacy & Safety of Sorafenib Compared With Placebo When Administered in Combination With Modified FOLFOX6 for the Treatment of Metastatic CRC Subjects previously untreated for Stage IV disease
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2