NCT01538680 (CONSIGN) is a clinical trial of Regorafenib (BAY73-4506) in Colorectal Neoplasms, sponsored by Bayer.

Who is sponsoring NCT01538680?

NCT01538680 is sponsored by Bayer.

What drugs are being tested in NCT01538680?

Interventions in NCT01538680: Regorafenib (BAY73-4506).

What condition does NCT01538680 study?

NCT01538680 studies Colorectal Neoplasms.

Is NCT01538680 still recruiting?

NCT01538680 is currently no longer available. Last updated 29 May 2019.

Last reviewed 2019-05-29 · How we verify

NCT01538680: CONSIGN

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Regorafenib in Subjects With Metastatic Colorectal Cancer (CRC) Who Have Progressed After Standard Therapy

NO LONGER AVAILABLE Last updated 29 May 2019

What this trial tests

trial testing Regorafenib (BAY73-4506) in Colorectal Neoplasms. No longer available.

Quick facts

Lead sponsor	Bayer
Status	NO LONGER AVAILABLE
Study type	EXPANDED_ACCESS
Sites	207 locations across Italy, Finland, Ireland, Poland, Denmark, Netherlands, Russia, Belgium

Drugs / interventions tested

Regorafenib (BAY73-4506) — full drug profile →

Conditions studied

Colorectal Neoplasms — all drugs for Colorectal Neoplasms →

Sponsor

Bayer — full company profile →

Who can join

18 and older, any sex, with Colorectal Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Regorafenib for Patients with Metastatic Colorectal Cancer Who Progressed After Standard Therapy: Results of the Large, Single-Arm, Open-Label Phase IIIb CONSIGN Study.
Van Cutsem E, Martinelli E, Cascinu S, Sobrero A, et al · · 2019 · cited 95× · PMID 30190299 · DOI 10.1634/theoncologist.2018-0072
Management of regorafenib-related toxicities: a review.
Krishnamoorthy SK, Relias V, Sebastian S, Jayaraman V, et al · · 2015 · cited 67× · PMID 26327919 · DOI 10.1177/1756283x15580743
Evolution of regorafenib from bench to bedside in colorectal cancer: Is it an attractive option or merely a "me too" drug?
Goel G. · · 2018 · cited 42× · PMID 29563833 · DOI 10.2147/cmar.s88825
Anti-VEGF agents in metastatic colorectal cancer (mCRC): are they all alike?
Saif MW. · · 2013 · cited 35× · PMID 23807861 · DOI 10.2147/cmar.s45193
Clinical management of regorafenib in the treatment of patients with advanced colorectal cancer.
Sastre J, Argilés G, Benavides M, Feliú J, et al · · 2014 · cited 23× · PMID 25223744 · DOI 10.1007/s12094-014-1212-8
Practical considerations in the use of regorafenib in metastatic colorectal cancer.
Loupakis F, Antonuzzo L, Bachet JB, Kuan FC, et al · · 2020 · cited 20× · PMID 33193826 · DOI 10.1177/1758835920956862
Anti-angiogenic therapies for metastatic colorectal cancer: current and future perspectives.
Marques I, Araújo A, de Mello RA. · · 2013 · cited 20× · PMID 24307789 · DOI 10.3748/wjg.v19.i44.7955
Efficacy and safety of regorafenib and fruquintinib as third-line treatment for colorectal cancer: a narrative review.
Xu X, Yu Y, Liu M, Liang L, et al · · 2022 · cited 18× · PMID 35261903 · DOI 10.21037/tcr-20-3539

Verify or expand the search:

Other trials of Regorafenib (BAY73-4506)

Trials testing the same drug.

NCT02085148 — A Phase I Dose Finding Study in Children With Solid Tumors Recurrent or Refractory to Standard Therapy · Phase 1 · completed
NCT00960258 — Phase I Study to Investigate Pharmacokinetics and Safety of BAY73-4506 in Asian (Japanese) Patients With Solid Tumors. · Phase 1 · completed
NCT01689376 — Regorafenib in Subjects With Gastrointestinal Stromal Tumors (GIST) Who Have Progressed After Standard Therapy (Managed · no longer available
NCT01646593 — Regorafenib in Subjects With Gastrointestinal Stromal Tumors (GIST) Who Have Progressed After Standard Therapy · no longer available

Other recruiting trials for Colorectal Neoplasms

Currently open trials in the same condition.

NCT06983639 — Randomized Trial Comparing Fecal Testing (FIT) to Colonoscopy for Post-polypectomy Surveillance · NA · recruiting
NCT07222800 — Symbiotic-GI-03: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult · Phase 3 · recruiting
NCT07239479 — DEXDES Trial: Dexmedetomidine-Desflurane Combination in Laparoscopic Colectomy · NA · recruiting
NCT07262840 — Health Behavior Change in High-Risk Colorectal Cancer Individuals · NA · recruiting
NCT07257653 — The Safety and Efficacy of Cetuximab Beta Plus Fruquintinib With or Without Immune Checkpoint Inhibitorrs in First-line · Phase 2 · recruiting

Other Bayer trials

Trials by the same sponsor.

NCT05900388 — A Study to Observe the Pattern of Use and Safety of Rivaroxaban in Children Under 2 Years Old With Venous Thromboembolis · not yet recruiting
NCT07490431 — An Observational Study to Learn More About How Elinzanetant is Used and How Well it Works for Women With Menopause Sympt · not yet recruiting
NCT05477953 — An Observational Pregnancy Safety Study in Women Who Were Exposed to the Drug Nifurtimox During Pregnancy to Learn About · not yet recruiting
NCT07192952 — A Study to Learn More About How Safe Finerenone is, When it is Taken for a Longer Time With Standard Treatment, in Child · Phase 3 · not yet recruiting
NCT07450599 — A Study to Learn How Well a Combination of Darolutamide and Androgen Deprivation Therapy (ADT) Works as a Treatment Befo · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01538680 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bayer
Last refreshed: 29 May 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01538680.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing