NCT02042144 (Correlate) is a clinical trial of Stivarga (Regorafenib, BAY73-4506) in Neoplasms, sponsored by Bayer.

Who is sponsoring NCT02042144?

NCT02042144 is sponsored by Bayer.

What drugs are being tested in NCT02042144?

Interventions in NCT02042144: Stivarga (Regorafenib, BAY73-4506).

Is NCT02042144 still recruiting?

NCT02042144 is currently completed. Last updated 16 January 2018.

Last reviewed 2018-01-16 · How we verify

NCT02042144: Correlate

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

Safety and Effectiveness of Regorafenib

Completed Last updated 16 January 2018

What this trial tests

trial testing Stivarga (Regorafenib, BAY73-4506) in Neoplasms in 1,034 participants. Completed in 10 November 2017.

Timeline

8 April 2014

Primary endpoint
19 August 2017

10 November 2017

Quick facts

Lead sponsor	Bayer
Status	Completed
Study type	OBSERVATIONAL
Enrollment	1,034
Start date	8 April 2014
Primary completion	19 August 2017
Estimated completion	10 November 2017
Sites	13 locations across Denmark, France, Italy, Netherlands, Austria, Taiwan, Mexico, Argentina

Drugs / interventions tested

Stivarga (Regorafenib, BAY73-4506) — full drug profile →

Conditions studied

Neoplasms — all drugs for Neoplasms →

Sponsor

Bayer — full company profile →

Who can join

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

Sponsor's own description

This study is a prospective observational cohort study. The study will be conducted in routine clinical practice settings. It is planned to enroll 1000 patients with metastatic Colorectal Cancer (mCRC) who have been previously treated with other approved treatments for metastatic disease and for whom a decision has been made by the physician to treat with regorafenib according to local health authority approved label. It is the aim of this observational cohort study to further characterize safety and effectiveness of regorafenib in routine clinical practice setting. Healthcare resource utilization in the routine provision of care is becoming increasingly important from a health economics and outcomes research perspective. Therefore, another aim of this observational cohort study is to capture healthcare resource associated with the management of treatment emergent adverse events in the real world setting. The primary objective of this study is to further characterize safety of regorafenib use in routine clinical practice settings. The secondary objective of this study is to assess the effectiveness of regorafenib in routine clinical practice settings as measured by Overall Survival (OS), Progression Free Survival (PFS) and Disease control rate (DCR). Health Related Quality of Life (HRQoL) Data will be collected in applicable countries.

Publications & conference data

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

Genomic Medicine and Implications for Hepatocellular Carcinoma Prevention and Therapy.
Dhanasekaran R, Nault JC, Roberts LR, Zucman-Rossi J. · · 2019 · cited 157× · PMID 30404026 · DOI 10.1053/j.gastro.2018.11.001
Safety and effectiveness of regorafenib in patients with metastatic colorectal cancer in routine clinical practice in the prospective, observational CORRELATE study.
Ducreux M, Petersen LN, Öhler L, Bergamo F, et al · · 2019 · cited 58× · PMID 31698328 · DOI 10.1016/j.ejca.2019.09.015
The role of tumor angiogenesis as a therapeutic target in colorectal cancer.
Battaglin F, Puccini A, Intini R, Schirripa M, et al · · 2018 · cited 48× · PMID 29338550 · DOI 10.1080/14737140.2018.1428092
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
Real-world evidence of the safety and effectiveness of regorafenib in Taiwanese patients with metastatic colorectal cancer: CORRELATE Taiwan.
Yeh KH, Yang TS, Hsu TC, Tzu-Liang Chen W, et al · · 2021 · cited 10× · PMID 33422398 · DOI 10.1016/j.jfma.2020.12.015
Regorafenib in patients with metastatic colorectal cancer in Spain: from clinical trials to real-world evidence.
Cervantes A, Tabernero J, Garcia-Carbonero R, Sastre J, et al · · 2024 · cited 1× · PMID 38861286 · DOI 10.1080/14796694.2024.2340422
P-277A prospective, observational trial to assess the safety and efficacy of regorafenib in patients with metastatic colorectal cancer (mCRC) in routine clinical practice (CORRELATE)
Michel D, Alfredo F, Punt C, Svetlana K, et al · · 2016

Verify or expand the search:

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Currently open trials in the same condition.

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Other Bayer trials

Trials by the same sponsor.

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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 NCT02042144 (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: 16 January 2018

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/NCT02042144.

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