Trial Condition(s):

Colorectal Neoplasms

Asian subjects with metastatic colorectal cancer treated with Regorafenib or placebo after failure of standard therapy (CONCUR)

Bayer Identifier:

15808

ClinicalTrials.gov Identifier:

NCT01584830

EudraCT Number:

Not Available

Study Completed

Trial Purpose

The purpose of this study is to assess if Regorafenib in combination with best supportive care will slow down tumor progression and result in increased survival in patients with metastatic colorectal cancer.

Inclusion Criteria
- Histological or cytological documentation of adenocarcinoma of the colon or rectum. All other histological types are excluded.
 - Subjects with metastatic colorectal cancer(CRC) (Stage IV).
 - Subjects must have failed at least two lines of prior treatment.
 - Progression during or within 3 months following the last administration of approved standard therapies which must include a fluoropyrimidine, oxaliplatin and irinotecan.
 -- Subjects treated with oxaliplatin in an adjuvant setting should have progressed during or within 6 months of completion of adjuvant therapy.
 -- Subjects who progress more than 6 months after completion of oxaliplatin containing adjuvant treatment must be retreated with oxaliplatin-based therapy to be eligible.
 -- Subjects who have withdrawn from standard treatment due to unacceptable toxicity warranting discontinuation of treatment and precluding retreatment with the same agent prior to progression of disease will also be allowed into the study.
 -- Subjects may have received prior treatment with Avastin (bevacizumab) and/or Erbitux (cetuximab)/Vectibix (panitumumab)  (if KRAS WT)
 - Metastatic CRC subjects must have measurable or non measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, version 1.1.
 - Eastern Cooperative Oncology Group (ECOG) Performance Status of 1.
 - Life expectancy of at least 3 months.
 - Adequate bone marrow, liver and renal function as assessed by the laboratory required by protocol.
Exclusion Criteria
- Prior treatment with Regorafenib.
 - Previous or concurrent cancer that is distinct in primary site or histology from colorectal cancer within 5 years prior to randomization EXCEPT for curatively treated cervical cancer in situ, non-melanoma skin cancer and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor invades lamina propria)].
 - Extended field radiotherapy within 4 weeks or limited field radiotherapy within 2 weeks prior to randomization.
 - Cardiological disease including Congestive heart failure, Unstable angina, Myocardial infarction, Cardiac arrhythmias requiring anti-arrhythmic therapy.
 - Uncontrolled hypertension. (Systolic blood pressure 150 mmHg or diastolic pressure 90 mmHg despite optimal medical management).
 - Subjects with phaeochromocytoma.
 - Pleural effusion or ascites that causes respiratory compromise.
 - Arterial or venous thrombotic or embolic events.
 - Any history of or currently known brain metastases.
 - Interstitial lung disease with ongoing signs and symptoms at the time of informed consent.
 - Systemic anticancer therapy including cytotoxic therapy, signal transduction inhibitors, immunotherapy, and hormonal therapy during this trial or within 4 week.

Trial Summary

Enrollment Goal
204
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
Yes
Products
Stivarga (Regorafenib, BAY73-4506)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Seoul, South Korea, 138-736

Status
Completed
 
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Investigative Site

Taipei, Taiwan, China, 10002

Status
Completed
 
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Investigative Site

Taipei, Taiwan, China, 11217

Status
Completed
 
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Investigative Site

Taoyuan, Taiwan, China, 333

Status
Completed
 
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Investigative Site

Hong Kong, Hong Kong, China

Status
Completed
 
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Investigative Site

Shatin, Hong Kong, China

Status
Completed
 
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Investigative Site

Shanghai, China, 200030

Status
Completed
 
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Investigative Site

Beijing, China, 100071

Status
Completed
 
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Investigative Site

Guangzhou, China, 510060

Status
Completed
 
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Investigative Site

Nanjing, China, 210002

Status
Completed
 
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Investigative Site

Beijing, China, 100142

Status
Completed
 
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Investigative Site

Beijing, China, 100021

Status
Completed
 
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Investigative Site

Hangzhou, China, 310016

Status
Completed
 
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Investigative Site

Changchun, China, 130021

Status
Completed
 
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Investigative Site

Tianjin, China, 300060

Status
Completed
 
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Investigative Site

Qingdao, China, 266003

Status
Completed
 
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Investigative Site

Harbin, China, 150081

Status
Completed
 
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Investigative Site

Shanghai, China, 200080

Status
Completed
 
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Investigative Site

Shanghai, China, 200032

Status
Completed
 
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Investigative Site

Chengdu, China, 610041

Status
Completed
 
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Investigative Site

Guangzhou, China, 510080

Status
Completed
 
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Investigative Site

Xi'an, China, 710032

Status
Completed
 
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Investigative Site

Hanoi, Vietnam

Status
Completed
 
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Investigative Site

HCMC, Vietnam

Status
Completed
 
Locations

Investigative Site

Ho Chi Minh City, Vietnam

Status
Completed
 

Trial Design