Trial Condition(s):
Metastatic Colorectal Cancer
Study of Modified FOLFOX6 plus or minus Sorafenib in Stage IV metastatic colorectal carcinoma (mCRC) subjects
Bayer Identifier:
13162
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
To determine if sorafenib when added to chemotherapy will slow disease progression more than chemotherapy alone in patients previously untreated for metastatic colorectal cancer.
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Cancer Research UK - Glasgow Glasgow, United Kingdom, G61 1BD | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Aberdeen Royal Infirmary Aberdeen, United Kingdom, AB25 2ZN | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Nottingham City Hospital Nottingham, United Kingdom, NG5 1PB | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Mount Vernon Hospital Northwood, United Kingdom, HA6 2RN | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Bristol Haematology and Oncology Centre Bristol, United Kingdom, BS2 8ED | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Princess Royal Hospital Hull, United Kingdom, HU8 9HE | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Queen's University Belfast, United Kingdom, BT7 1NN | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Via Christi Regional Medical Center Wichita, United States, 67214 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Uniwersyteckie Centrum Kliniczne Gdansk, Poland, 80-952 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Wojskowy Instytut Medyczny Warszawa, Poland, 04-141 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations POZ nr 1 Szpitala Uniwersyteckiego Krakow, Poland, 31-501 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Wojewodzki Szpital Zespolony Elblag, Poland, 82-300 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dolnoslaskie Centrum Onkologii Wroclaw, Poland, 53-413 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations ASL TO/2 - Piemonte Torino, Italy, 10153 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. Integrata Verona Verona, Italy, 37134 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Clínico Universitario de Valencia Valencia, Spain, 46010 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Universitario Virgen del Rocío Sevilla, Spain, 41013 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Regional Carlos Haya Málaga, Spain, 29010 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Universitario "Marqués de Valdecilla" Santander, Spain, 39008 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ciutat Sanitària i Universitària de Bellvitge L'Hospitalet de Llobregat, Spain, 08907 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Universitari Son Espases Palma de Mallorca, Spain, 07010 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Clínic i Provincial de Barcelona Barcelona, Spain, 08036 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Institut Català d'Oncologia L'Hospitalet de Llobregat, Spain, 08907 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hôpital Erasme/Erasmus Ziekenhuis BRUXELLES - BRUSSEL, Belgium, 1070 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations ZNA Middelheim ANTWERPEN, Belgium, 2020 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations UZ Gent GENT, Belgium, 9000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Petz Aladar Megyei Korhaz Gyor, Hungary, 9024 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Debrecen Medical&Health Science Center Debrecen, Hungary, 4032 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Bacs-Kiskun Country Hospital Kecskemet, Hungary, 6000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Szegedi Tudomanyegyetem, SZAOTE Szeged, Hungary, 6720 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Christie Hospital Manchester, United Kingdom, M20 4BX | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Freeman Hospital Newcastle Upon Tyne, United Kingdom, NE7 7DN | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Queen Alexandra Hospital Portsmouth, United Kingdom, PO6 3LY | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University College London Hospitals London, United Kingdom, WC1E 6BT | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Royal Liverpool University Hospital Liverpool, United Kingdom, L7 8XP | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Lahey Clinic Medical Center Burlington, United States, 01805 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hematology and Oncology Specialists, LLC Metairie, United States, 70006 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Mary Crowley Medical Research Center Dallas, United States, 75246 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Medical Oncology/Hematology Associates Brockton, United States, 02301 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centrum Onkologii - Instytut im. M.Sklodowskiej-Curie Warszawa, Poland, 02-781 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Bialostockie Centrum Onkologii im. M. Sklodowskiej-Curie Bialystok, Poland, 15-027 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centrum Onkologii Instytut im. M. Sklodowskiej-Curie Krakow, Poland, 31-115 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations ZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii Olsztyn, Poland, 10-228 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Szpital Morski im. PCK Gdynskie Centrum Onkologii Gdynia, Poland, 81-519 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Oncology Research Center & Treatment Medical Center Ekaterinburg, Russia, 620036 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Railways Hospital named after Semashko Moscow, Russia, 129128 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Regional Oncology Center Chelyabinsk, Russia, 454087 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Research Institute of Oncology Rostov-on-Don, Russia, 350086 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations City Clinical Oncology Center St. Petersburg, Russia, 197022 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinical Oncology Center Magnitogorsk, Russia, 455001 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Krasnodar Region Oncology Centre Krasnodar, Russia, 350040 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Regional Oncology Center St. Petersburg, Russia, 191104 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinical Oncology Center Arkhangelsk, Russia, 163045 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kursk Regional Oncology Center Kursk, Russia, 305035 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Regional Oncology Center Irkutsk, Russia, 664035 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Oncology Center no 2 Sochi, Russia, 354057 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinical Oncologz Center Samara, Russia, 443031 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinical Oncology Center no 1 Volgograd, Russia, 400138 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Central Clinical Hospital Moscow, Russia, 121356 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations State Medical Institution Tula Regional Oncology Center Tula, Russia, 300053 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations IRCCS A.O.U. San Martino – IST Ist. Nazionale Ricerca Cancro Genova, Italy, 16132 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. Santa Maria Misericordia UD Udine, Italy, 33100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations AULSS 08 Asolo - Veneto Castelfranco Veneto, Italy, 31033 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. Santa Maria degli Angeli Pordenone, Italy, 33170 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations AUSL 6 Palermo - Sicilia Palermo, Italy, 90146 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations ASUR Marche ZT09 Macerata Macerata, Italy, 62100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ciutat Sanitària i Universitaria de la Vall d'Hebron Barcelona, Spain, 08035 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Universitario 12 de Octubre Madrid, Spain, 28041 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Althaia, Xarxa Assistencial de Manresa Manresa, Spain, 08240 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Instituto Valenciano de Oncología Valencia, Spain, 46009 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations UZ Leuven Gasthuisberg LEUVEN, Belgium, 3000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations CHC LIEGE, Belgium, 4000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Institut Jules Bordet/Jules Bordet Instituut BRUXELLES - BRUSSEL, Belgium, 1000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations ZNA Middelheim ANTWERPEN, Belgium, 2020 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Szent Margit Hospital Budapest, Hungary, 1032 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Novosibirsk State-Funded Medical Institution Novosibirsk, Russia, 630047 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Medical Care Unit N 122 St. Petersburg, Russia, 194291 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ivanovo Regional Oncology Center Ivanovo, Russia, 153013 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Lugansk Regional Oncology Center Lugansk, Ukraine, 91047 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Regional Oncology Center Uzhgorod , Ukraine, 88014 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Regional Public Institution, Krivoy Rog Oncology Center Krivoy Rog, Ukraine, 50048 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Lviv State Regional Diagnostics and TreatmentOncology Center Lviv, Ukraine, 79031 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Donetsk Regional Oncological Center Regional Antitumor Cente Donetsk, Ukraine, 83092 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations National Cancer Institute Kiev, Ukraine, 03022 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kharkov Regional Oncology Center Kharkov, Ukraine, 61070 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dnepropetrovsk Regional Oncology Center Dnipropetrovsk, Ukraine, 49055 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Mariupol City Interdistrict Oncology Center Mariupol, Ukraine, 87500 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Medical Oncology Center Iasi, Romania, 700106 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Bajcsy Zsilinszky Hospital Budapest, Hungary, 1106 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Fejer megyei Szent Gyorgy Korhaz Szekesfehervar, Hungary, 8000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Fovarosi Szent Laszlo Korhaz Budapest, Hungary, 1097 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Russian Oncological Scientific Center n.a. N.N. Blokhin RAMS Moscow, Russia, 115478 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinical Oncology Hospital Yaroslavl, Russia, 150054 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Medical Radiol. Research Centre of Minzdravsocrazvitie, FGBU Obninsk, Russia, 249036 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinical Oncology Center Ulyanovsk, Russia, 432063 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinical Oncology Center Izhevsk, Russia, 426009 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Komi Republican Oncology Center Syktyvkar, Russia, 167904 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations City Hospital no 9 St. Petersburg, Russia, 197110 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Pjatigorsk Affiliate of Stavropol Clinical Oncology Center Pjatygorsk, Russia, 357502 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinical Oncology Dispensary Kazan, Russia, 420029 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinical Oncology Center Vladimir , Russia, 600020 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Petrov Research Instutute of Oncology St. Petersburg, Russia, 198255 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Regional Oncologz Center Astrakhan, Russia, 414041 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Institutul Oncologic "Prof. Dr. Ioan Chiricuta" Cluj-Napoca, Romania, 400015 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Spitalul de urgenta "Sf. Ioan Cel Nou" Suceava, Romania, 720237 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Fundeni Clinical Institute Bucharest, Romania, 022326 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Alba Iulia Emergency Country Hospital Alba Iulia, Romania, 510039 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Federal State Institution Nizhny Novgorod, Russia, 603001 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Territorial Clinical Center of Oncology Khabarovsk, Russia, 680022 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations City General Hosp #4, Dnepropetrovsk State Medical Academy Dnepropetrovsk, Ukraine, 49102 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ivano-Frankovsk Regional Oncology Center MU Ivano-Frankovsk, Ukraine, 76000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Communal establishment "Cherkassy Regional Oncology Center" Cherkassy, Ukraine, 18009 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sumy Regional Oncology Center Sumy, Ukraine, 40005 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Oncomed SRL Timisoara, Romania, 300239 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Meditech SRL Craiova-Dolj, Romania, 200535 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations OradeaCountry Emergency Clinical Hospital Oradea, Romania, 410032 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Emergency Country Hospital Baia Mare "Dr. Constantin Opris" Baia Mare, Romania, 430031 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Oncomed SRL Timisoara, Romania, 300239 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Prof. Dr. Alexandru Trestioreanu Institute of Oncology Bucharest, Romania, 022328 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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
Primary Outcome
- Progression-Free Survival (PFS)Timeframe: From randomization of the first subject until 23 months later, assessed every 8 weeks
Secondary Outcome
- Overall Survival (OS)Timeframe: From randomization of the first subject until 33 months later
- Time to Progression (TTP)Timeframe: From randomization of the first subject until 23 months later, assessed every 8 weeks
- Overall responseTimeframe: From randomization of the first subject until 23 months later, assessed every 8 weeks
- Duration of ResponseTimeframe: From randomization of the first subject until 23 months later, assessed every 8 weeks
Additional Information
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