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| Name | Class |
|---|---|
| Peking University Cancer Hospital & Institute | OTHER |
| Sun Yat-sen University | OTHER |
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Famitinib is a tyrosin-inhibitor agent targeting at c-Kit, VEGFR2, PDGFR, VEGFR3, Flt1 and Flt3, and it's anti-angiogenesis effect has been viewed in preclinical tests. Phase I study has shown that the toxicity is manageable.
The purpose of this study is to determine whether Famitinib can improve progression free survival compared with placebo in patients with advanced colorectal cancer who failed in previous at least two lines of chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Famitinib | Experimental | Famitinib 25 mg qd p.o. and the medication continued until disease progression or intolerable toxicity or patients withdrawal of consent |
|
| Placebo | Placebo Comparator | Placebo qd p.o., and the medication continued until disease progression or intolerable toxicity or patients withdrawal of consent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Famitinib | Drug | Famitinib 25 mg p.o. qd |
| |
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival(PFS) | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate(ORR) | 12 weeks | |
| Disease Control Rate(DCR) | 12 weeks | |
| Overall Survival(OS) |
| Measure | Description | Time Frame |
|---|---|---|
| body vitals, laboratory parameters | 3 years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shen Lin, M.D | Beijing Cancer Hospital, Peking University | Principal Investigator |
| Ruihua Xu, M.D | Cancer Center, Sun Yet-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer center, Sun Yet-sen University | Guangzhou | Guangdong | China | |||
| Beijing Cancer Hospital, Peking University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29273089 | Derived | Xu RH, Shen L, Wang KM, Wu G, Shi CM, Ding KF, Lin LZ, Wang JW, Xiong JP, Wu CP, Li J, Liu YP, Wang D, Ba Y, Feng JP, Bai YX, Bi JW, Ma LW, Lei J, Yang Q, Yu H. Famitinib versus placebo in the treatment of refractory metastatic colorectal cancer: a multicenter, randomized, double-blinded, placebo-controlled, phase II clinical trial. Chin J Cancer. 2017 Dec 22;36(1):97. doi: 10.1186/s40880-017-0263-y. |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| C584390 | famitinib |
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| Other |
p.o. qd |
|
| 3 years |
| Quality of Life | 42-day cycle visit until disease progress |
| Number of Participants with Adverse Events as a Measure of Safety | 3 years |
| Beijing |
| China |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |