Colorectal NeoplasmsCONSIGNNCT01538680
Regorafenib in Subjects With Metastatic Colorectal Cancer (CRC) Who Have Progressed After Standard Therapy
A study testing Regorafenib (BAY73-4506) in people with Colorectal Neoplasms, run by Bayer at 207 sites in 25 countries.
Trial summary
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 /… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- Regorafenib (BAY73-4506)
- How many people
- Not given
- Where
- 207 sitesin 25 countries
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 </= Grade 2
- 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 locations and contacts
207 sites in 25 countries.
207 sites in 25 countries
United States62 sites
Study site
Ann Arbor, Michigan, 48106
Study site
Atlanta, Georgia, 30318
Study site
Aventura, Florida, 33180
Study site
Boston, Massachusetts, 02215-5450
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Brewer, Maine, 04412
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Burlington, Massachusetts, 01805
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Cedar Rapids, Iowa, 52403
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Charleston, South Carolina, 29414
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Charlotte, North Carolina, 28203
Study site
Cincinnati, Ohio, 45219
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Cleveland, Ohio, 44195
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Columbus, Georgia, 31904
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Dallas, Texas, 75390-9110
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Denver, Colorado, 80218
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Detroit, Michigan, 48201
Study site
Detroit, Michigan, 48202
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Duarte, California, 91010
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Fargo, North Dakota, 58122
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Jackson, Mississippi, 39202
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Jacksonville, Florida, 32224
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Jefferson City, Missouri, 65109
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La Jolla, California, 92037
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La Jolla, California, 92093-0987
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Lake Success, New York, 11042
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Las Vegas, Nevada, 89169
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Lebanon, New Hampshire, 03756
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Long Beach, California, 90813
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Los Angeles, California, 90033
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Louisville, Kentucky, 40202
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Memphis, Tennessee, 38120
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Miami Beach, Florida, 33140
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Nashville, Tennessee, 37232
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New Haven, Connecticut, 06520
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New Orleans, Louisiana, 70121
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New York, New York, 10003
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New York, New York, 10016
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New York, New York, 10021
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Ocala, Florida, 34474
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Omaha, Nebraska, 68106
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Orange, California, 92868-3201
Study site
Orlando, Florida, 32804
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Park Ridge, Illinois, 60068
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Philadelphia, Pennsylvania, 19104
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Philadelphia, Pennsylvania, 19107
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Philadelphia, Pennsylvania, 19111-2497
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Portland, Oregon, 97239
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Portsmouth, Virginia, 23704
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Providence, Rhode Island, 02908
Study site
Richmond, Virginia, 23298-0037
Study site
Rochester, Minnesota, 55905
Study site
Santa Maria, California, 93454
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Savannah, Georgia, 31405
Study site
Seattle, Washington, 98104
Study site
Shreveport, Louisiana, 71130
Study site
Sioux City, Iowa, 51101
Study site
Stony Brook, New York, 11794
Study site
Sumter, South Carolina, 29150
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Temple, Texas, 76508
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The Bronx, New York, 10461
Study site
Toledo, Ohio, 43617
Study site
Washington D.C., District of Columbia, 20007
Study site
Winston-Salem, North Carolina, 27157
Germany25 sites
Study site
Berlin, 12200
Study site
Bochum, North Rhine-Westphalia, 44892
Study site
Cologne, North Rhine-Westphalia, 50924
Study site
Dresden, Saxony, 01307
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Essen, North Rhine-Westphalia, 45122
Study site
Esslingen am Neckar, Baden-Wurttemberg, 73730
Study site
Freiburg im Breisgau, Baden-Wurttemberg, 79106
Study site
Halle, Saxony-Anhalt, 06120
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Hamburg, 20246
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Hanover, Lower Saxony, 30625
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Heidelberg, Baden-Wurttemberg, 69120
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Herne, North Rhine-Westphalia, 44625
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Leverkusen, North Rhine-Westphalia, 51375
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Magdeburg, Saxony-Anhalt, 39104
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Mannheim, Baden-Wurttemberg, 68167
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Mönchengladbach, North Rhine-Westphalia, 41063
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München, Bavaria, 81377
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München, Bavaria, 81737
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München, Bavaria, 81925
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Oldenburg, Lower Saxony, 26133
Study site
Porta Westfalica, North Rhine-Westphalia, 32457
Study site
Recklinghausen, North Rhine-Westphalia, 45657
Study site
Stuttgart, Baden-Wurttemberg, 70199
Study site
Trier, Rhineland-Palatinate, 54290
Study site
Ulm, Baden-Wurttemberg, 89081
France16 sites
Study site
Avignon, 84000
Study site
Bordeaux
Study site
Clermont-Ferrand, 63003
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Le Mans, 72015
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Lille, 59020
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Lille, 59037
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Marseille, 13005
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Montpellier, 34298
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Nice, 06102
Study site
Paris, 75571
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Paris, 75651
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Paris, 75908
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Reims, 51092
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Saint-Herblain, 44805
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Strasbourg, 67085
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Toulouse, 31059
Spain16 sites
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A Coruña, 15006
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Badalona (Barcelona), Barcelona, 08916
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Barcelona, 08035
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Barcelona, 08036
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Córdoba, Andalusia, 14004
Study site
L'Hospitalet de Llobregat, Barcelona, 08907
Study site
Madrid, 28007
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Madrid, 28034
Study site
Madrid, 28040
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Madrid, 28041
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Madrid, 28046
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Málaga, 29010
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Sabadell, Barcelona, 08208
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Santander, Cantabria, 39008
Study site
Seville, 41013
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Valencia, 46014
Italy15 sites
Study site
Ancona, The Marches, 60126
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Brescia, Lombardy, 25124
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Florence, Tuscany, 50134
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Foggia, Apulia, 71013
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Genoa, Liguria, 16132
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Milan, Lombardy, 20089
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Milan, Lombardy, 20133
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Milan, Lombardy, 20162
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Modena, Emilia-Romagna, 41124
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Naples, Campania, 80131
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Padova, Veneto, 35128
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Palermo, Sicily, 90127
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Pisa, Tuscany, 56126
Study site
Reggio Emilia, Emilia-Romagna, 42123
Study site
Rome, Lazio, 00168
Mexico10 sites
Study site
Aguascalientes, 20230
Study site
Guadalajara, Jalisco, 44670
Study site
Irapuato, Guanajuato, 36500
Study site
Mexico City, Mexico City, 01120
Study site
Mexico City, Mexico City, 14050
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Mexico City, Mexico City, 14080
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México, D.F., Mexico City, 14080
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Oaxaca City, 68000
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Toluca, 50180
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Veracruz, 91910
Russia8 sites
Study site
Kazan', 420029
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Krasnodar, 350040
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Moscow, 115478
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Moscow, 119991
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Obninsk, 249036
Study site
Orenburg, 460021
Study site
Saint Petersburg, 197022
Study site
Saint Petersburg, 197758
Canada7 sites
Study site
Calgary, Alberta, T2N 4N2
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Edmonton, Alberta, T6G 1Z2
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Mississauga, Ontario, L5M 2N1
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Montreal, Quebec, H2W 1S6
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Oshawa, Ontario, L1G 2B9
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Québec, G1R 2J6
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Toronto, Ontario, M4N 3M5
Belgium6 sites
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Bruxelles - Brussel, 1000
Study site
Bruxelles - Brussel, 1070
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Bruxelles - Brussel, 1200
Study site
Edegem, 2650
Study site
Leuven, 3000
Study site
Roeselare, 8800
Australia5 sites
Study site
Concord, New South Wales, 2139
Study site
Footscray, Victoria, 3011
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Parkville, Victoria, 3050
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St Leonards, New South Wales, 2065
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Woodville South, South Australia, 5011
Israel5 sites
Study site
Beersheba, 8410101
Study site
Haifa, 3109601
Study site
Jerusalem, 9112001
Study site
Petah Tikva, 4941492
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Tel Aviv, 6423906
Switzerland5 sites
Study site
Basel, Canton of Basel-City, 4031
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Bern, 3010
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Chur, Kanton Graubünden, 7000
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Geneva, 1205
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Zurich, 8091
Austria4 sites
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Graz, Styria, 8036
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Innsbruck, Tyrol, 6020
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Vienna, 1090
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Wels, Upper Austria, 4600
Netherlands3 sites
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Amsterdam, 1081 HV
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Amsterdam, 1105 AZ
Study site
Leiden, 2333 ZA
United Kingdom2 sites
Study site
Leicester, Leicestershire, LE1 5WW
Study site
Manchester, M20 4BX
About this study
Official title: An Open-label Phase IIIb Study of Regorafenib in Patients With Metastatic Colorectal Cancer (CRC) Who Have Progressed After Standard Therapy
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.
- Conditions
- Colorectal Neoplasms
- Being tested
- Regorafenib (BAY73-4506)
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regorafenib (BAY73-4506)Drug
Subjects will receive 160 mg regorafenib po every day (qd) for 3 weeks of every 4 week cycle (i.e., 3 weeks on, 1 week off). Subjects will continue on treatment until at least one of the following occurs (main criteria):
Progressive Disease (PD). The subject may continue treatment at the investigator's discretion.
Death Unacceptable toxicity Subject withdraws consent Treating physician determines discontinuation of treatment is in the subject's best interest Substantial non-compliance with the protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01538680
- Sponsor's protocol ID
- 15967
- Other IDs
- 2011-005836-25
- Acronym
- CONSIGN
- Status last verified
- May 2019
- First submitted
- 21 Feb 2012
- Last updated
- 29 May 2019
- Results posted
- No
Publications
Cervantes A, Tabernero J, Garcia-Carbonero R, Sastre J, Feliu J, Carmen Guillen-Ponce, Paredes BG, Carral A, Munoz J. Regorafenib in patients with metastatic colorectal cancer in Spain: from clinical trials to real-world evidence. Future Oncol. 2024;20(20):1401-1413. doi: 10.1080/14796694.2024.2340422. Epub 2024 Jun 11.
PubMed 38861286Van Cutsem E, Martinelli E, Cascinu S, Sobrero A, Banzi M, Seitz JF, Barone C, Ychou M, Peeters M, Brenner B, Hofheinz RD, Maiello E, Andre T, Spallanzani A, Garcia-Carbonero R, Arriaga YE, Verma U, Grothey A, Kappeler C, Miriyala A, Kalmus J, Falcone A, Zaniboni A. Regorafenib for Patients with Metastatic Colorectal Cancer Who Progressed After Standard Therapy: Results of the Large, Single-Arm, Open-Label Phase IIIb CONSIGN Study. Oncologist. 2019 Feb;24(2):185-192. doi: 10.1634/theoncologist.2018-0072. Epub 2018 Sep 6.
PubMed 30190299
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Phase IIIb Study of Regorafenib in Patients With Metastatic Colorectal Cancer (CRC) Who Have Progressed After Standard Therapy
- ClinicalTrials.gov ID
- NCT01538680
- Acronym / sponsor ID
- CONSIGN / 15967
- Conditions
- Colorectal Neoplasms
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- First posted
- 24 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Regorafenib (BAY73-4506)Subjects will receive 160 mg regorafenib po every day (qd) for 3 weeks of every 4 week cycle (i.e., 3 weeks on, 1 week off). Subjects will continue on treatment until at least one of the following occurs (main criteria): Progressive Disease (PD). The subject may continue treatment at the investigator's discretion. Death Unacceptable toxicity Subject withdraws consent Treating physician determines discontinuation of treatment is in the subject's best interest Substantial non-compliance with the protocol | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2019.
- Derived from this study: PubMed 38861286Cervantes A, Tabernero J, Garcia-Carbonero R, Sastre J, Feliu J, Carmen Guillen-Ponce, Paredes BG, Carral A, Munoz J. Regorafenib in patients with metastatic colorectal cancer in Spain: from clinical trials to real-world evidence. Future Oncol. 2024;20(20):1401-1413. doi: 10.1080/14796694.2024.2340422. Epub 2024 Jun 11.
- Derived from this study: PubMed 30190299Van Cutsem E, Martinelli E, Cascinu S, Sobrero A, Banzi M, Seitz JF, Barone C, Ychou M, Peeters M, Brenner B, Hofheinz RD, Maiello E, Andre T, Spallanzani A, Garcia-Carbonero R, Arriaga YE, Verma U, Grothey A, Kappeler C, Miriyala A, Kalmus J, Falcone A, Zaniboni A. Regorafenib for Patients with Metastatic Colorectal Cancer Who Progressed After Standard Therapy: Results of the Large, Single-Arm, Open-Label Phase IIIb CONSIGN Study. Oncologist. 2019 Feb;24(2):185-192. doi: 10.1634/theoncologist.2018-0072. Epub 2018 Sep 6.
- Click here to find information about studies related to Bayer Healthcare products conducted in Europe.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
207 sites in 25 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regorafenib (BAY73-4506) in people with Colorectal Neoplasms, run by Bayer at 207 sites in 25 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 207 sites in United States, Germany, France, Spain, Italy and 20 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01538680, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2019.