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

ClinicalTrials.gov ID: NCT01538680

Public ClinicalTrials.gov record NCT01538680. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Oct 20, 2026, 12:38 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

An Open-label Phase IIIb Study of Regorafenib in Patients With Metastatic Colorectal Cancer (CRC) Who Have Progressed After Standard Therapy

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID: NCT01538680
Recruitment status: No Longer Available
Study type: Expanded access
Phase: Not listed
Lead sponsor: Bayer; Industry
Enrollment: Not listed

Conditions and interventions

Conditions

Colorectal Neoplasms

Interventions

Regorafenib (BAY73-4506) Drug

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Not listed

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Not listed
Primary completion: Not listed
Completion: Not listed
Last update posted: May 29, 2019

United States locations

U.S. sites: 62
U.S. states: 31
U.S. cities: 56

Facility	City	State	ZIP	Site status
Not listed	Duarte	California	91010	—
Not listed	La Jolla	California	92037	—
Not listed	La Jolla	California	92093-0987	—
Not listed	Long Beach	California	90813	—
Not listed	Los Angeles	California	90033	—
Not listed	Orange	California	92868-3201	—
Not listed	Santa Maria	California	93454	—
Not listed	Denver	Colorado	80218	—
Not listed	New Haven	Connecticut	06520	—
Not listed	Washington D.C.	District of Columbia	20007	—
Not listed	Aventura	Florida	33180	—
Not listed	Jacksonville	Florida	32224	—
Not listed	Miami Beach	Florida	33140	—
Not listed	Ocala	Florida	34474	—
Not listed	Orlando	Florida	32804	—
Not listed	Atlanta	Georgia	30318	—
Not listed	Columbus	Georgia	31904	—
Not listed	Savannah	Georgia	31405	—
Not listed	Park Ridge	Illinois	60068	—
Not listed	Cedar Rapids	Iowa	52403	—
Not listed	Sioux City	Iowa	51101	—
Not listed	Louisville	Kentucky	40202	—
Not listed	New Orleans	Louisiana	70121	—
Not listed	Shreveport	Louisiana	71130	—
Not listed	Brewer	Maine	04412	—
Not listed	Boston	Massachusetts	02215-5450	—
Not listed	Burlington	Massachusetts	01805	—
Not listed	Ann Arbor	Michigan	48106	—
Not listed	Detroit	Michigan	48201	—
Not listed	Detroit	Michigan	48202	—
Not listed	Rochester	Minnesota	55905	—
Not listed	Jackson	Mississippi	39202	—
Not listed	Jefferson City	Missouri	65109	—
Not listed	Omaha	Nebraska	68106	—
Not listed	Las Vegas	Nevada	89169	—
Not listed	Lebanon	New Hampshire	03756	—
Not listed	Lake Success	New York	11042	—
Not listed	New York	New York	10003	—
Not listed	New York	New York	10016	—
Not listed	New York	New York	10021	—
Not listed	Stony Brook	New York	11794	—
Not listed	The Bronx	New York	10461	—
Not listed	Charlotte	North Carolina	28203	—
Not listed	Winston-Salem	North Carolina	27157	—
Not listed	Fargo	North Dakota	58122	—
Not listed	Cincinnati	Ohio	45219	—
Not listed	Cleveland	Ohio	44195	—
Not listed	Toledo	Ohio	43617	—
Not listed	Portland	Oregon	97239	—
Not listed	Philadelphia	Pennsylvania	19104	—
Not listed	Philadelphia	Pennsylvania	19107	—
Not listed	Philadelphia	Pennsylvania	19111-2497	—
Not listed	Providence	Rhode Island	02908	—
Not listed	Charleston	South Carolina	29414	—
Not listed	Sumter	South Carolina	29150	—
Not listed	Memphis	Tennessee	38120	—
Not listed	Nashville	Tennessee	37232	—
Not listed	Dallas	Texas	75390-9110	—
Not listed	Temple	Texas	76508	—
Not listed	Portsmouth	Virginia	23704	—
Not listed	Richmond	Virginia	23298-0037	—
Not listed	Seattle	Washington	98104	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 145 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT01538680, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted May 29, 2019 · Synced Oct 20, 2026

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01538680 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →