- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01584830
Asian Subjects With Metastatic Colorectal Cancer Treated With Regorafenib or Placebo After Failure of Standard Therapy (CONCUR)
February 5, 2016 updated by: Bayer
A Randomized, Double-blind, Placebo-controlled Phase III Study of Regorafenib Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Asian Subjects With Metastatic Colorectal Cancer (CRC) Who Have Progressed After Standard Therapy
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
204
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Beijing, China, 100021
-
Beijing, China, 100142
-
Beijing, China, 100071
-
Changchun, China, 130021
-
Shanghai, China, 200032
-
Shanghai, China, 200030
-
Shanghai, China, 200080
-
Tianjin, China, 300060
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510080
-
Guangzhou, Guangdong, China, 510060
-
-
Heilongjiang
-
Harbin, Heilongjiang, China, 150056
-
-
Jiangsu
-
Nanjing, Jiangsu, China, 210002
-
-
Shaanxi
-
Xi'an, Shaanxi, China, 710032
-
-
Shandong
-
Qingdao, Shandong, China, 266003
-
-
Sichuan
-
Chengdu, Sichuan, China, 610041
-
-
Zhejiang
-
Hangzhou, Zhejiang, China, 310016
-
-
-
-
-
Hong Kong, Hong Kong
-
-
New Territories
-
Shatin, New Territories, Hong Kong
-
-
-
-
Korea
-
Seoul, Korea, Korea, Republic of, 138-736
-
-
-
-
-
Taipei, Taiwan, 11217
-
Taipei, Taiwan, 10016
-
Taoyuan, Taiwan, 333
-
-
-
-
-
Hanoi, Vietnam
-
Hcmc, Vietnam
-
Ho Chi Minh City, Vietnam, 84
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm 1
|
Regorafenib BAY73-4506 will be given 3 weeks on/1 week off (160 mg od po.)
|
Placebo Comparator: Arm 2
|
Placebo will be given 3 weeks on/1 week off (160 mg od po.)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Survival (OS)
Time Frame: From randomization of the first subject untill 154 death events observed, up to 2 years
|
OS is defined as the time from date of randomization to death due to any cause.
Subjects still alive at the time of analysis were censored at their last date of last contact.
|
From randomization of the first subject untill 154 death events observed, up to 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free Survival (PFS)
Time Frame: From randomization of the first subject untill 154 death events observed, up to 2 years
|
PFS was defined as the time from date of randomization to disease progression radiological/clinical or death due to any cause, whichever occurs first.
Subjects without progression or death at the time of analysis were censored at their last date of tumor evaluation.
|
From randomization of the first subject untill 154 death events observed, up to 2 years
|
The percentage of subjects with total number of Complete Response (CR) + total number of Partial Response (PR).
Time Frame: From randomization of the first subject untill 154 death events observed, up to 2 years
|
From randomization of the first subject untill 154 death events observed, up to 2 years
|
|
Disease Control Rate (DCR)
Time Frame: From randomization of the first subject untill 154 death events observed, up to 2 years
|
DCR is defined as the percentage of subjects whose best response was not Progressive Disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) (= total number of Complete Response (CR) + total number of Partial Response (PR) + total number of Stable Disease (SD); CR, PR, or SD had to be maintained for at least 28 days from the first demonstration of that rating)
|
From randomization of the first subject untill 154 death events observed, up to 2 years
|
Safety variables will be summarized using descriptive statistics based on adverse events collection
Time Frame: From randomization of the first subject untill 154 death events observed, up to 2 years
|
From randomization of the first subject untill 154 death events observed, up to 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2012
Primary Completion (Actual)
November 1, 2013
Study Completion (Actual)
January 1, 2016
Study Registration Dates
First Submitted
April 24, 2012
First Submitted That Met QC Criteria
April 24, 2012
First Posted (Estimate)
April 25, 2012
Study Record Updates
Last Update Posted (Estimate)
February 8, 2016
Last Update Submitted That Met QC Criteria
February 5, 2016
Last Verified
February 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15808
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Colorectal Neoplasms
-
City of Hope Medical CenterRecruitingColorectal Neoplasms | Colorectal Cancer | Colorectal Adenocarcinoma | Colorectal Cancer Stage II | Colorectal Cancer Stage III | Colorectal Cancer Stage IV | Colorectal Neoplasms Malignant | Colorectal Cancer Stage IUnited States, Japan, Italy, Spain
-
NuCana plcCompletedColorectal Neoplasms | Colorectal Cancer | Colorectal Tumors | Colorectal Carcinoma | Neoplasms, ColorectalUnited States, France, United Kingdom
-
Emory UniversityBristol-Myers Squibb; National Cancer Institute (NCI); National Institutes of...Active, not recruitingColorectal Cancer Metastatic | Colorectal Adenocarcinoma | Stage IV Colorectal Cancer | Stage IVA Colorectal Cancer | Stage IVB Colorectal Cancer | Refractory Colorectal Carcinoma | Metastatic Microsatellite Stable Colorectal Carcinoma | Stage IVC Colorectal CancerUnited States
-
The Queen Elizabeth HospitalNovartis; AmgenCompletedColorectal Cancer | Colorectal Tumors | Colorectal Carcinoma | Neoplasms, ColorectalAustralia
-
Novartis PharmaceuticalsCompletedColorectal Cancer | Colorectal Tumors | Colorectal Carcinoma | Neoplasms, ColorectalUnited States
-
ProgenaBiomeRecruitingColorectal Neoplasms | Colorectal Cancer | Colorectal Cancer Metastatic | Colorectal Carcinoma | Colorectal Adenocarcinoma | Colorectal SarcomaUnited States
-
Pawel KalinskiNational Cancer Institute (NCI)CompletedColorectal Neoplasms | Colorectal Cancer | Colorectal Tumors | Colorectal Carcinoma | Neoplasms, ColorectalUnited States
-
Jeremy MeyerUniversity Hospital, Geneva; Hôpital Fribourgeois; Spital Biel, SwitzerlandNot yet recruitingColorectal Neoplasms | Colorectal Cancer | Colorectal Adenoma | Colorectal Adenocarcinoma | Colorectal Polyp | Colorectal Neoplasms Malignant | Colorectal Neoplasms, Benign
-
Bristol-Myers SquibbNovartisActive, not recruitingColorectal Cancer | Colorectal Neoplasm | Colorectal Tumors | Colorectal CarcinomaItaly, United States, Canada, Spain, Argentina, Australia, Belgium, Chile, Czechia, Germany
-
City of Hope Medical CenterRecruitingColorectal Neoplasms | Colorectal Cancer | Colorectal Disorders | Colorectal Adenocarcinoma | Colorectal Cancer Stage II | Colorectal Cancer Stage III | Colorectal Cancer Stage IV | Colorectal Polyp | Colorectal Neoplasms Malignant | Colorectal Adenomatous Polyp | Colorectal Cancer Stage I | Colorectal Adenoma... and other conditionsUnited States, Italy, China, Spain, Japan
Clinical Trials on Regorafenib (BAY73-4506)
-
BayerNo longer availableColorectal NeoplasmsFrance, Belgium, Spain, United States, Canada, Switzerland, Germany, Russian Federation, Australia, Austria, Israel, Italy, Mexico, Netherlands, Norway, United Kingdom, Poland, Hungary, Denmark, Portugal, Finland, Sweden, Ireland, Greece and more
-
BayerCompletedColorectal NeoplasmsKorea, Republic of
-
BayerCompleted
-
BayerCompletedColorectal NeoplasmsAustria
-
BayerCompletedPharmacokinetics | Dietary FatsUnited States
-
BayerCompleted
-
BayerCompletedNeoplasmsCanada, United States
-
BayerCompletedNeoplasmsHong Kong, Singapore