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Metastatic Colorectal CancerPhase 3NCT01103323

Patients With Metastatic Colorectal Cancer Treated With Regorafenib or Placebo After Failure of Standard Therapy

A Phase 3 study testing Regorafenib (Stivarga, BAY73-4506) in people with Metastatic Colorectal Cancer, run by Bayer at 171 sites in 19 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a randomized, double-blind, placebo-controlled multi-center phase III study to evaluate efficacy and safety of regorafenib in patients with metastatic colorectal cancer (CRC) who have progressed on/after all approved drugs for CRC Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Colorectal Cancer
What is being tested?
Regorafenib (Stivarga, BAY73-4506)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
760 participants
Where
171 sitesin 19 countries
Study dates
Apr 2010to Jan 2014
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histological or cytological documentation of adenocarcinoma of the colon or rectum
  • Progression during or within 3 months following the last administration of approved standard therapies. Patients treated with oxaliplatin in an adjuvant setting should have progressed during or within 6 months of completion of adjuvant therapy
  • Patients with measurable or non measurable disease
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of </= 1
  • Life expectancy of at least 3 months
  • Adequate bone marrow, liver and renal function

Who cannot join

  • Unstable/uncontrolled cardiac disease
  • History of arterial or venous thrombotic or embolic events
  • Symptomatic metastatic brain or meningeal tumors
  • Patients with evidence or history of bleeding diathesis
  • Interstitial lung disease - Persistent proteinuria >/= grade 3
  • Unresolved toxicity > grade 1 attributed to any prior therapy/procedure excluding alopecia and oxaliplatin induced neurotoxicity </= Grade 2

Trial locations and contacts

171 sites in 19 countries.

171 sites in 19 countries

United States26 sites

  • Study site

    Ann Arbor, Michigan, 48106

  • Study site

    Aventura, Florida, 33180

  • Study site

    Beverly Hills, California, 90211

  • Study site

    Cedar Rapids, Iowa, 52403

  • Study site

    Charleston, South Carolina, 29414

  • Study site

    Dallas, Texas, 75390-9110

  • Study site

    Fargo, North Dakota, 58122

  • Study site

    Green Bay, Wisconsin, 54303

  • Study site

    Jacksonville, Florida, 32224

  • Study site

    Jefferson City, Missouri, 65109

  • Study site

    Los Angeles, California, 90033

  • Study site

    Los Angeles, California, 90036

  • Study site

    Mission Hills, California, 91345

  • Study site

    Neptune City, New Jersey, 07754

  • Study site

    New Orleans, Louisiana, 70121

  • Study site

    New York, New York, 10011

  • Study site

    Orange, California, 92868

  • Study site

    Peoria, Illinois, 61615-7828

  • Study site

    Redlands, California, 92374

  • Study site

    Rochester, Minnesota, 55905

  • Study site

    Saint Cloud, Minnesota, 56303

  • Study site

    Salt Lake City, Utah, 84106

  • Study site

    Santa Maria, California, 93454

  • Study site

    Scranton, Pennsylvania, 18510

  • Study site

    Sumter, South Carolina, 29150

  • Study site

    Toledo, Ohio, 43623

Other trials in United States

Japan20 sites

  • Study site

    Bunkyo-ku, Tokyo, 113-8519

  • Study site

    Chiba, Chiba, 260-8717

  • Study site

    Chuo-ku, Tokyo, 104-0045

  • Study site

    Fukuoka, Fukuoka, 812-8582

  • Study site

    Hidaka, Saitama, 350-1298

  • Study site

    Kashiwa, Chiba, 277-8577

  • Study site

    Kita-Adachigun, Saitama, 362-0806

  • Study site

    Kochi, Kochi, 781-8555

  • Study site

    Koto-ku, Tokyo, 135-8550

  • Study site

    Kumamoto, Kumamoto, 860-8556

  • Study site

    Matsuyama, Ehime, 791-0280

  • Study site

    Mitaka, Tokyo, 181-8611

  • Study site

    Nagoya, Aichi-ken, 464-8681

  • Study site

    Osaka, Osaka, 540-0006

  • Study site

    Sapporo, Hokkaido, 060-8648

  • Study site

    Sayama, Osaka, 589-8511

  • Study site

    Shimotsuke, Tochigi, 329-0498

  • Study site

    Sunto, Shizuoka, 411-8777

  • Study site

    Takatsuki, Osaka, 569-8686

  • Study site

    Utsunomiya, Tochigi, 320-0834

Other trials in Japan

Germany18 sites

  • Study site

    Berlin, State of Berlin, 13125

  • Study site

    Cologne, North Rhine-Westphalia, 50924

  • Study site

    Dresden, Saxony, 01307

  • Study site

    Essen, North Rhine-Westphalia, 45122

  • Study site

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

  • Study site

    Halle, Saxony-Anhalt, 06120

  • Study site

    Hanover, Lower Saxony, 30625

  • Study site

    Karlsruhe, Baden-Wurttemberg, 76137

  • Study site

    Leverkusen, North Rhine-Westphalia, 51375

  • Study site

    Magdeburg, Saxony-Anhalt, 39104

  • Study site

    Mannheim, Baden-Wurttemberg, 68167

  • Study site

    München, Bavaria, 81377

  • Study site

    München, Bavaria, 81737

  • Study site

    München, Bavaria, 81925

  • Study site

    Oldenburg, Lower Saxony, 26133

  • Study site

    Porta Westfalica, North Rhine-Westphalia, 32457

  • Study site

    Stuttgart, Baden-Wurttemberg, 70199

  • Study site

    Trier, Rhineland-Palatinate, 54290

Other trials in Germany

China17 sites

  • Study site

    Beijing, 100021

  • Study site

    Beijing, 100071

  • Study site

    Changchun, 130021

  • Study site

    Chongqing, 400038

  • Study site

    Chongqing, 400042

  • Study site

    Fuzhou, 350014

  • Study site

    Fuzhou, 350025

  • Study site

    Guangzhou, Guangdong, 510060

  • Study site

    Guangzhou, Guangdong, 510515

  • Study site

    Ha’erbin, 150040

  • Study site

    Hanghzou, 310009

  • Study site

    Nanjing, Jiangsu, 210003

  • Study site

    Nanjing, Jiangsu, 210009

  • Study site

    Qingdao, Shandong, 266100

  • Study site

    Shanghai, 200001

  • Study site

    Shanghai, 200030

  • Study site

    Tianjin, 300060

Other trials in China

France10 sites

  • Study site

    Avignon, 84000

  • Study site

    Le Mans, 72015

  • Study site

    Lille, Lille Cedex, 59020

  • Study site

    Lille, 59037

  • Study site

    Marseille, 13005

  • Study site

    Montpellier, 34298

  • Study site

    Paris, 75651

  • Study site

    Reims, 51092

  • Study site

    Rennes, 35042

  • Study site

    Strasbourg, 67085

Other trials in France

Israel10 sites

  • Study site

    Ashkelon, 7830604

  • Study site

    Beersheba, 8410101

  • Study site

    Haifa, 3109601

  • Study site

    Holon

  • Study site

    Jerusalem, 9112001

  • Study site

    Petah Tikva, 4941492

  • Study site

    Rehovot, 7610001

  • Study site

    Tel Aviv, 6423906

  • Study site

    Tel HaShomer, 5262000

  • Study site

    Zrifin, Israel, 6093000

Other trials in Israel

Canada9 sites

  • Study site

    London, Ontario, N6A 4L6

  • Study site

    Mississauga, Ontario, L5M 2N1

  • Study site

    Moncton, New Brunswick, E1C 6Z8

  • Study site

    Montreal, Quebec, H3T 1E2

  • Study site

    Oshawa, Ontario, L1G 2B9

  • Study site

    Québec, Quebec, G1R 2J6

  • Study site

    Toronto, Ontario, M4N 3M5

  • Study site

    Vancouver, British Columbia, V5Z 4E6

  • Study site

    Winnipeg, Manitoba, R2H 2A6

Other trials in Canada

Italy9 sites

  • Study site

    Brescia, 25124

  • Study site

    Genova, 16132

  • Study site

    Milan, 20133

  • Study site

    Milan, 20162

  • Study site

    Modena, 41124

  • Study site

    Naples, 80131

  • Study site

    Pisa, 56126

  • Study site

    Reggio Emilia, 42100

  • Study site

    Roma, 00168

Other trials in Italy

Spain8 sites

  • Study site

    Barcelona, Barcelona, 08035

  • Study site

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Study site

    Madrid, Madrid, 28040

  • Study site

    Madrid, Madrid, 28041

  • Study site

    Madrid, Madrid, 28046

  • Study site

    Málaga, Málaga, 29010

  • Study site

    Sabadell, Barcelona, 08208

  • Study site

    Seville, Sevilla, 41013

Other trials in Spain

Australia6 sites

  • Study site

    Concord, New South Wales, 2139

  • Study site

    Footscray, Victoria, 3011

  • Study site

    Parkville, Victoria, 3050

  • Study site

    St Leonards, New South Wales, 2065

  • Study site

    Woodville South, South Australia, 5011

  • Study site

    Woolloogabba, Queensland, 4102

Other trials in Australia

Belgium6 sites

  • Study site

    Bruxelles - Brussel, 1000

  • Study site

    Bruxelles - Brussel, 1070

  • Study site

    Bruxelles - Brussel, 1200

  • Study site

    Edegem, 2650

  • Study site

    Leuven, 3000

  • Study site

    Roeselare, 8800

Other trials in Belgium

Argentina5 sites

  • Study site

    Buenos Aires, Ciudad Auton. de Buenos Aires, C1122AAL

  • Study site

    Buenos Aires, Ciudad Auton. de Buenos Aires, C1264AAA

  • Study site

    Capital Federal-Buenos Aires, C1426ANZ

  • Study site

    Rosario, Santa Fe Province, S2000PBJ

  • Study site

    San Miguel de Tucumán, Tucumán Province, T4000GTB

Other trials in Argentina

Portugal5 sites

  • Study site

    Aveiro, Aveiro District, 3810-096

  • Study site

    Coimbra, 3030-075

  • Study site

    Lisbon, 1649-035

  • Study site

    Porto, Porto District, 4099-001

  • Study site

    Porto, Porto District, 4200-072

Other trials in Portugal

Brazil4 sites

  • Study site

    Belo Horizonte, Minas Gerais, 30110-090

  • Study site

    Fortaleza, Ceará, 60160-230

  • Study site

    Ijuí, Rio Grande do Sul, 98700-000

  • Study site

    Salvador, Estado de Bahia, 41830-492

Other trials in Brazil

Czechia4 sites

  • Study site

    Brno, 65 653

  • Study site

    Hradec Králové, 500 05

  • Study site

    Olomouc, 775 20

  • Study site

    Prague, 18081

Other trials in Czechia

Hungary4 sites

  • Study site

    Budapest, 1082

  • Study site

    Debrecen, 4032

  • Study site

    Nyíregyháza, 4400

  • Study site

    Szeged, 6725

Other trials in Hungary

Netherlands4 sites

  • Study site

    Amsterdam, 1081 HV

  • Study site

    Hoofddorp, 2134 TM

  • Study site

    Leeuwarden, 8901 BR

  • Study site

    Leiden, 2333 ZA

Other trials in Netherlands

Turkey (Türkiye)4 sites

  • Study site

    Ankara, 06500

  • Study site

    Instanbul, 34662

  • Study site

    Istanbul, 34390

  • Study site

    Izmir, 35100

Other trials in Turkey (Türkiye)

Switzerland2 sites

  • Study site

    Chur, Kanton Graubünden, 7000

  • Study site

    Geneva, Canton of Geneva, 1211

Other trials in Switzerland

About this study

Official title: A Randomized, Double-blind, Placebo-controlled Phase III Study of Regorafenib Plus BSC Versus Placebo Plus BSC in Patients With Metastatic Colorectal Cancer (CRC) Who Have Progressed After Standard Therapy

This is a randomized, double-blind, placebo-controlled multi-center phase III study to evaluate efficacy and safety of regorafenib in patients with metastatic colorectal cancer (CRC) who have progressed on/after all approved drugs for CRC

Read the detailed description

All participants received Best Supportive Care. Acronyms used in Adverse events section: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE), International Normalized Ratio (INR), Central nervous system (CNS), Acute respiratory distress syndrome (ARDS), Cranial nerves (CN), Disseminated Intravascular Coagulation (DIC), Cardiac troponin T (cTnT).

Abbreviation used in Results section: Data Monitoring Committee (DMC). Adverse event collection will be covered in Adverse events section.

Being tested
Regorafenib (Stivarga, BAY73-4506), Placebo, Best Supportive Care (BSC)
Keywords
Metastatic Colorectal Cancer
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 (Stivarga, BAY73-4506)Drug

    160 mg per oral once daily for 3 weeks of every 4 week cycle (i.e., 3 weeks on, 1 week off)

  • PlaceboDrug

    matching placebo tablets for 3 weeks of every 4 week cycle (i.e., 3 weeks on, 1 week off)

  • Best Supportive Care (BSC)Other

    BSC includes any concomitant medications or treatments: antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any other symptomatic therapy necessary to provide BSC, except other investigational anti-tumor agents or anti-neoplastic chemo/hormonal/immuno-therapy.

Study groups in NCT01103323
Study groupRoleWhat they receive
Regorafenib (Stivarga, BAY73-4506)+BSCExperimentalParticipants received Regorafenib 160 mg per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus Best Supportive Care(BSC).
Receives: Drug: Regorafenib (Stivarga, BAY73-4506); Other: Best Supportive Care (BSC)
Placebo+BSCPlacebo comparatorParticipants received matching placebo tablets per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus Best Supportive Care (BSC).
Receives: Drug: Placebo; Other: Best Supportive Care (BSC)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival

    Overall survival (OS) was defined as the time (days) from randomization to death due to any cause. Patients alive at the time of analysis were censored at the last date known to be alive. If a patient was lost to follow-up and there was no contact after randomization, this patient was censored at Day 1.

    Measured: From randomization of the first subject until the database cut-off approximately 14 months later (19May2010 - 21Jul2011) used for 2nd planned formal interim analysis (IA).

Secondary outcomes (4)

  1. Progression-free Survival (Based on Investigator's Assessment)

    Progression-free survival was defined as the time (days) from date of randomization to date of first observed disease progression (radiological or clinical) or death due to any cause, if death occurred before progression was documented.

    Measured: From randomization of the first subject until the database cut-off approximately 14 months later (19May2010 - 21Jul2011) used for 2nd planned formal interim analysis. Tumor assessed at 8 week intervals.

  2. Objective Tumor Response

    The objective tumor response was defined as the percentage of patients with complete response (CR, tumor disappears) or partial response (PR, sum of lesion sizes decreased at least 30% from baseline) as best overall response. A best overall response was defined for all patients, using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria, version 1.1. Patients whose best overall response was not CR or PR, and any patients with no post-baseline assessments were considered nonresponders for the analysis.

    Measured: From randomization of the first subject until the database cut-off approximately 14 months later (19May2010 - 21Jul2011) used for 2nd planned formal interim analysis. Tumor assessed at 8 week intervals.

  3. Disease Control

    Disease control was defined as the percentage of patients whose best response was not PD [sum of lesion sizes increased at least 20% from smallest sum on study or new lesions] (ie, CR [tumor disappears], PR [sum of lesion sizes decreased at least 30% from baseline] or SD (stable disease)). SD included if at least 6 weeks after randomization.

    Measured: From randomization of the first subject until the database cut-off approximately 14 months later (19May2010 - 21Jul2011) used for 2nd planned formal interim analysis. Tumor assessed at 8 week intervals.

  4. Tumor Response

    A tumor response (best overall response) was defined for all patients, using the RECIST criteria, version 1.1. Categories: complete response (CR, tumor disappears), partial response (PR, sum of lesion sizes decreased at least 30% from baseline), stable disease (SD, steady state of disease), progressive disease (PD, sum of lesion sizes increased at least 20% from smallest sum on study or new lesions). Clinical PD considered when radiographic imaging not possible.

    Measured: From randomization of the first subject until the database cut-off approximately 14 months later (19May2010 - 21Jul2011) used for 2nd planned formal interim analysis. Tumor assessed at 8 week intervals.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2010 (estimated)
  2. Study startApr 2010
  3. Primary completionJul 2011
  4. Study completionJan 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
760 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01103323
Sponsor's protocol ID
14387
Other IDs
2009-012787-14, 2009
Status last verified
May 2015
First submitted
8 Apr 2010
Last updated
24 Jun 2015
Data monitoring committee
Yes

Publications

  • Grothey A, Van Cutsem E, Sobrero A, Siena S, Falcone A, Ychou M, Humblet Y, Bouche O, Mineur L, Barone C, Adenis A, Tabernero J, Yoshino T, Lenz HJ, Goldberg RM, Sargent DJ, Cihon F, Cupit L, Wagner A, Laurent D; CORRECT Study Group. Regorafenib monotherapy for previously treated metastatic colorectal cancer (CORRECT): an international, multicentre, randomised, placebo-controlled, phase 3 trial. Lancet. 2013 Jan 26;381(9863):303-12. doi: 10.1016/S0140-6736(12)61900-X. Epub 2012 Nov 22.

    PubMed 23177514

  • Mross K, Frost A, Steinbild S, Hedbom S, Buchert M, Fasol U, Unger C, Kratzschmar J, Heinig R, Boix O, Christensen O. A phase I dose-escalation study of regorafenib (BAY 73-4506), an inhibitor of oncogenic, angiogenic, and stromal kinases, in patients with advanced solid tumors. Clin Cancer Res. 2012 May 1;18(9):2658-67. doi: 10.1158/1078-0432.CCR-11-1900. Epub 2012 Mar 15.

    PubMed 22421192

  • 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 38861286

  • Tabernero J, Lenz HJ, Siena S, Sobrero A, Falcone A, Ychou M, Humblet Y, Bouche O, Mineur L, Barone C, Adenis A, Yoshino T, Goldberg RM, Sargent DJ, Wagner A, Laurent D, Teufel M, Jeffers M, Grothey A, Van Cutsem E. Analysis of circulating DNA and protein biomarkers to predict the clinical activity of regorafenib and assess prognosis in patients with metastatic colorectal cancer: a retrospective, exploratory analysis of the CORRECT trial. Lancet Oncol. 2015 Aug;16(8):937-48. doi: 10.1016/S1470-2045(15)00138-2. Epub 2015 Jul 13.

    PubMed 26184520

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Regorafenib (Stivarga, BAY73-4506) in people with Metastatic Colorectal Cancer, run by Bayer at 171 sites in 19 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 6 inclusion and 6 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: finished, as of the sponsor's last update on 24 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 171 sites in United States, Japan, Germany, China, France and 14 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Nov 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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.

What does the primary outcome measure?

Overall Survival (time frame: From randomization of the first subject until the database cut-off approximately 14 months later (19May2010 - 21Jul2011) used for 2nd planned formal interim analysis (IA).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01103323, which also lists 4 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 24 Jun 2015.

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