check_circleStudy Completed

Colorectal neoplasms

Regorafenib in subjects with metastatic colorectal cancer (CRC) who have progressed after standard therapy

Trial purpose

This is a phase III B, prospective, interventional, open-label, single-arm, multicenter study to provide regorafenib to subjects diagnosed with metastatic colorectal cancer who have failed after standard therapy and for whom no therapy alternatives exist, in the time between positive results and approval / availability on the market, and to collect safety data for regorafenib until market access.
Regorafenib is an oral (i.e. taken by mouth) multi-targeted kinase inhibitor. A kinase inhibitor targets certain key proteins that are essential for the survival of the cancer cell. By specifically targeting these proteins, regorafenib may stop cancer growth. The growth of the tumor may be decreased by preventing these specific proteins from functioning.
The primary endpoint of this study will be safety.

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - Male or female subjects 18 years of age
    - Life expectancy of at least 3 months
    - Histological or cytological documentation of adenocarcinoma of the colon or rectum. All other histological types are excluded.
    - Subjects with metastatic colorectal cancer (Stage IV)
    - Progression during or within 3 months following the last administration of approved standard therapies which must include fluoropyrimidine, oxaliplatin, irinotecan, bevacizumab and cetuximab/panitumumab (if KRAS WT) (WT: wild type)
    - ECOG Performance Status of ≤ 1 (ECOG: Eastern Cooperative Oncology Group)
    - Adequate bone marrow, liver and renal function
    - Women of childbearing potential and men must agree to use adequate contraception
  • - Prior treatment with regorafenib
    - Congestive heart failure >/= New York Heart Association (NYHA) class 2
    - Uncontrolled hypertension (Systolic blood pressure > 140 mmHg or diastolic pressure > 90 mmHg despite optimal medical management)
    - Any hemorrhage or bleeding event >/= CTCAE Grade 3 within 4 weeks prior to the start of study medication.
    - Persistent proteinuria of CTCAE Grade 3 (>3.5g/24 hours)
    - Unresolved toxicity higher than CTCAE (v. 4.0) Grade 1 attributed to any prior therapy/procedure excluding alopecia, hypothyroidism and oxaliplatin induced neurotoxicity - Systemic anticancer therapy including cytotoxic therapy, signal transduction inhibitors, immunotherapy, and hormonal therapy during this trial or within 4 weeks (or within 6 weeks for mitomycin C) before starting to receive study medication

Trial summary

Enrollment Goal
N/A
Trial Dates
null - Today
Phase
N/A
Could I Receive a placebo
No
Products
Stivarga (Regorafenib, BAY73-4506)
Accepts Healthy Volunteer
N/A

Where to participate

StatusInstitutionLocation
Completed
Halle, 06120, Germany
Completed
Porta Westfalica, 32457, Germany
Withdrawn
Rochester, 55905, United States
Completed
Sumter, 29150, United States
Completed
Santa Maria, 93454, United States
Completed
Charleston, 29414, United States
Completed
Cedar Rapids, 52403, United States
Completed
Jefferson City, 65109, United States
Completed
Ann Arbor, 48106, United States
Completed
Aventura, 33180, United States
Completed
Los Angeles, 90033, United States
Completed
Dallas, 75390-9110, United States
Completed
New Orleans, 70121, United States
Completed
Barcelona, 08035, Spain
Completed
Sevilla, 41013, Spain
Completed
Sabadell, 08208, Spain
Completed
Madrid, 28041, Spain
Completed
Málaga, 29010, Spain
Completed
Madrid, 28040, Spain
Completed
Madrid, 28046, Spain
Completed
Hospitalet de Llobregat, 08907, Spain
Completed
Madrid, 28034, Spain
Completed
Montreal, H2W 1S6, Canada
Completed
Mississauga, L5M 2N1, Canada
Completed
Oshawa, L1G 2B9, Canada
Completed
Toronto, M4N 3M5, Canada
Completed
Praha, 18081, Czech Republic
Completed
Brno, 65 653, Czech Republic
Completed
Haifa, 3109601, Israel
Completed
Tel Aviv, 6423906, Israel
Completed
Petah Tikva, 4941492, Israel
Completed
Jerusalem, 9112001, Israel
Completed
Beer Sheva, 8410101, Israel
Completed
Manchester, M20 4BX, United Kingdom
Completed
Leicester, LE1 5WW, United Kingdom
Completed
AMSTERDAM, 1081 HV, Netherlands
Completed
LEIDEN, 2333 ZA, Netherlands
Completed
Concord, 2139, Australia
Completed
Parkville, 3050, Australia
Completed
Footscray, 3011, Australia
Completed
Woodville South, 5011, Australia
Completed
St Leonards, 2065, Australia
Completed
Genova, 16132, Italy
Completed
Napoli, 80131, Italy
Completed
Modena, 41124, Italy
Completed
Pisa, 56126, Italy
Completed
Milano, 20162, Italy
Completed
Brescia, 25124, Italy
Completed
Roma, 00168, Italy
Completed
Napoli, 80131, Italy
Completed
Reggio Emilia, 42123, Italy
Completed
Ancona, 60126, Italy
Completed
Santander, 39008, Spain
Completed
LEUVEN, 3000, Belgium
Completed
ROESELARE, 8800, Belgium
Completed
BRUXELLES - BRUSSEL, 1000, Belgium
Completed
BRUXELLES - BRUSSEL, 1200, Belgium
Completed
EDEGEM, 2650, Belgium
Completed
BRUXELLES - BRUSSEL, 1070, Belgium
Completed
Genève, 1205, Switzerland
Withdrawn
Fargo, 58122, United States
Completed
München, 81377, Germany
Completed
München, 81737, Germany
Completed
Oldenburg, 26133, Germany
Completed
Magdeburg, 39104, Germany
Completed
München, 81925, Germany
Completed
Essen, 45122, Germany
Completed
Trier, 54290, Germany
Completed
Dresden, 01307, Germany
Completed
Köln, 50924, Germany
Completed
Mannheim, 68167, Germany
Completed
Hannover, 30625, Germany
Completed
Freiburg, 79106, Germany
Completed
Freiburg, 79106, Germany
Completed
Herne, 44625, Germany
Completed
Recklinghausen, 45659, Germany
Completed
Lake Success, 11042, United States
Completed
Avignon, 84000, France
Completed
PARIS, 75571, France
Completed
PARIS, 75651, France
Completed
LILLE CEDEX, 59020, France
Completed
LILLE CEDEX, 59037, France
Completed
LE MANS CEDEX 2, 72015, France
Completed
REIMS CEDEX, 51092, France
Completed
MARSEILLE, 13005, France
Completed
MONTPELLIER CEDEX, 34298, France
Completed
Strasbourg Cedex, 67085, France
Withdrawn
Washington, 20007, United States
Completed
New Haven, 06520, United States
Completed
New York, 10016, United States
Completed
Denver, 80218, United States
Completed
La Jolla, 92037, United States
Completed
Detroit, 48201, United States
Completed
Portsmouth, 23704, United States
Completed
New York, 10021, United States
Completed
Park Ridge, 60068, United States
Completed
Seattle, 98104, United States
Withdrawn
Charlotte, 28203, United States
Withdrawn
Temple, 76508, United States
Withdrawn
Jacksonville, 32224, United States
Completed
Philadelphia, 19111-2497, United States
Withdrawn
Louisville, 40202, United States
Withdrawn
New York, 10016, United States
Completed
New York, 10003, United States
Completed
Duarte, 91010, United States
Completed
Detroit, 48202, United States
Withdrawn
Burlington, 01805, United States
Completed
Jackson, 39202, United States
Completed
Brewer, 04412, United States
Completed
Richmond, 23298-0037, United States
Withdrawn
La Jolla, 92093-0987, United States
Completed
Columbus, 31904, United States
Completed
Portland, 97239, United States
Withdrawn
Stony Brook, 11794, United States
Withdrawn
Boston, 02215-5450, United States
Withdrawn
Orange, 92868-3201, United States
Completed
Atlanta, 30318, United States
Completed
Omaha, 68106, United States
Completed
Miami Beach, 33140, United States
Completed
Cincinnati, 45219, United States
Completed
Bronx, 10461, United States
Completed
Providence, 02908, United States
Completed
Nashville, 37232, United States
Withdrawn
Winston-Salem, 27157, United States
Completed
Cleveland, 44195, United States
Completed
Shreveport, 71130, United States
Withdrawn
Philadelphia, 19104, United States
Completed
Ocala, 34474, United States
Completed
Memphis, 38120, United States
Completed
Innsbruck, 6020, Austria
Completed
Graz, 8036, Austria
Completed
Wien, 1090, Austria
Completed
Poznan, 60-569, Poland
Completed
Bialystok, 15-027, Poland
Completed
Long Beach, 90813, United States
Completed
Savannah, 31405, United States
Completed
Las Vegas, 89169, United States
Withdrawn
Orlando, 32804, United States
Withdrawn
Toledo, 43617, United States
Withdrawn
Philadelpahia, 19107, United States
Completed
Sioux City, 51101, United States
Completed
Lebanon, 03756, United States
Completed
Dublin, 24, Ireland
Completed
Cork, Ireland
Completed
AMSTERDAM, 1105 AZ, Netherlands
Completed
Oslo, 0450, Norway
Completed
Budapest, 1097, Hungary
Completed
Zürich, 8091, Switzerland
Completed
Chur, 7000, Switzerland
Completed
Helsinki, 00180, Finland
Completed
Leverkusen, 51375, Germany
Completed
Bochum, 44892, Germany
Withdrawn
Bochum, 44892, Germany
Completed
SAINT HERBLAIN, 44805, France
Completed
Bordeaux, France
Completed
Nice, 06102, France
Completed
CLERMONT-FERRAND Cedex 1, 63003, France
Completed
Toulouse, 31059, France
Completed
Porto, 4200- 319, Portugal
Completed
Coimbra, 3030-075, Portugal
Completed
Palermo, 90127, Italy
Completed
Foggia, 71013, Italy
Completed
Firenze, 50134, Italy
Completed
Milano, 20089, Italy
Completed
Padova, 35128, Italy
Completed
Milano, 20133, Italy
Completed
Wels, 4600, Austria
Completed
Obninsk, 249036, Russian Federation
Completed
St. Petersburg, 197022, Russian Federation
Withdrawn
St. Petersburg, 197758, Russian Federation
Completed
Edmonton, T6G 1Z2, Canada
Completed
Barcelona, 08036, Spain
Completed
A Coruña, 15006, Spain
Completed
Badalona (Barcelona), 08916, Spain
Completed
Madrid, 28007, Spain
Completed
Mönchengladbach, 41063, Germany
Completed
Hamburg, 20246, Germany
Completed
Esslingen, 73730, Germany
Completed
Berlin, 12200, Germany
Completed
Valencia, 46014, Spain
Completed
Córdoba, 14004, Spain
Completed
Uppsala, 751 85, Sweden
Withdrawn
Linköping, 581 85, Sweden
Completed
Bern, 3010, Switzerland
Completed
Heraklion, 711 10, Greece
Completed
Kifissia / Athens, 14564, Greece
Completed
Ulm, 89081, Germany
Completed
Basel, 4031, Switzerland
Completed
PARIS CEDEX 15, 75908, France
Completed
Helsinki, 00290, Finland
Completed
Aarhus C, 8000, Denmark
Completed
Copenhagen, 2100, Denmark
Completed
Calgary, T2N 4N2, Canada
Completed
Veracruz, 91910, Mexico
Completed
Oaxaca, 68000, Mexico
Withdrawn
Guadalajara, 44670, Mexico
Completed
Mexico, D.F., 01120, Mexico
Completed
Mexico, D.F., 14050, Mexico
Completed
México, D.F., 14080, Mexico
Completed
Aguascalientes, 20230, Mexico
Completed
Quebec, G1R 2J6, Canada
Completed
Toluca, 50180, Mexico
Completed
Irapuato, 36500, Mexico
Completed
México, 14080, Mexico
Withdrawn
Moscow, 115478, Russian Federation
Completed
Krasnodar, 350040, Russian Federation
Completed
Orenburg, 460021, Russian Federation
Completed
Kazan, 420029, Russian Federation
Completed
Moscow, 119991, Russian Federation

Trial design

An open-label phase IIIb study of regorafenib in patients with metastatic colorectal cancer (CRC) who have progressed after standard therapy
Trial Type
Expanded Access
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A