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.
Drug: Regorafenib (BAY73-4506)
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Locations near you
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Full eligibility criteria for NCT01584830
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
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Subjects who have withdrawn from standard treatment due to unacceptable toxicity warranting discontinuation of treatment and precluding retreatment with the same agent prior to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.
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.
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.
All locations for NCT01584830
Guangzhou, Guangdong, China, 510060
Guangzhou, Guangdong, China
Guangzhou, Guangdong, China, 510080
Guangzhou, Guangdong, China
Harbin, Heilongjiang, China
Nanjing, Jiangsu, China, 210002
Nanjing, Jiangsu, China
Xi'an, Shaanxi, China, 710032
Qingdao, Shandong, China, 266003
Qingdao, Shandong, China
Chengdu, Sichuan, China, 610041
Chengdu, Sichuan, China
Hangzhou, Zhejiang, China, 310016
Hangzhou, Zhejiang, China
Beijing, China, 100021
Beijing, China, 100071
Beijing, China, 100142
Changchun, China, 130021
Shanghai, China, 200030
Shanghai, China, 200032
Shanghai, China, 200080
Tianjin, China, 300060
Shatin, New Territories, Hong Kong
Hong Kong, Hong Kong
Seoul, Korea, Korea, Republic of, 138-736
Taipei, Taiwan, 10016
Taipei, Taiwan, 11217
Taoyuan, Taiwan, 333
Ho Chi Minh City, Vietnam, 84
Ho Chi Minh City, Vietnam
View full eligibility
Tris trial is registered with FDA with number: NCT01584830. The sponsor of the trial is Bayer and it is looking for 204 volunteers for the current phase.
Official trial title: 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
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