Dose Escalation of Icotinib in Advanced Non-small Cell Lung Carcinoma (NSCLC) Patients Evaluated as Stable Disease
NCT ID: NCT01690390
Last Updated: 2014-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
180 participants
INTERVENTIONAL
2012-09-30
2016-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Icotinib of Routine Dose
Oral Drug icotinib 125 mg three times per day
Icotinib of routine dose
Icotinib of routine dose: 125 mg is administered orally three times per day.
Icotinib of High Dose
Oral Drug icotinib 250 mg three times per day
Icotinib of high dose
Icotinib: 250 mg is administered orally three times per day.
Interventions
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Icotinib of routine dose
Icotinib of routine dose: 125 mg is administered orally three times per day.
Icotinib of high dose
Icotinib: 250 mg is administered orally three times per day.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* No previous targeted treatment such as gefitinib, erlotinib.
* With a measurable disease(longest diameters \>=10mm with Spiral computed tomography (CT)and \>=20mm with conventional CT) at least according to RECIST Criteria
* WHO performance status(PS)\<= 2
* N\>=1.5×109/L, Plt\>=1.0×109/L,Hb\>=10g/dL;AST\&ALT should \<3ULN(without liver metastasis) or \<5ULN(with liver metastasis).TBIL\<=1.5ULN.
* Signed and dated informed consent before the start of specific protocol procedures.
Exclusion Criteria
* Patients with metastatic brain tumors with symptoms.
* Experience of Anti-EGFR(the epidermal growth factor receptor) Monoclonal Antibody or small molecular compounds therapy such as gefitinib, erlotinib or Cetuximab.
* Severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases.
18 Years
75 Years
ALL
No
Sponsors
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Betta Pharmaceuticals Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Zhang Yi Ping, M.D.
Role: PRINCIPAL_INVESTIGATOR
Zhejiang Cancer Hospital
Locations
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Fujian Hospital for Chest Tumors & Tuberculosis Diseases
Fuzhou, Fujian, China
Fujian Provincal Hospital
Fuzhou, Fujian, China
Fujian Provincal Cancer Hospital
Fuzhou, Fujian, China
The second hospital of Xiamen City
Xiamen, Fujian, China
Hunan Provincal Cancer Hospital
Changsha, Hunan, China
The Second People's Hospital of Sichuan
Chengdu, Sichuan, China
Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, China
The First Affiliated Hospital of Medical School of Zhejiang University
Hangzhou, Zhejiang, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Zhejiang Traditional Chinese Medical Hospital
Hangzhou, Zhejiang, China
Zhejiang Hospital
Hangzhou, Zhejiang, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
Yinzhou People's Hospital
Ningbo, Zhejiang, China
Ningbo Medical Treatment Center Lihuili Hospital
Ningbo, Zhejiang, China
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical College
Wenzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Chen Qun, M.D.
Role: primary
Cui Tongjian, M.D.
Role: primary
Huang Cheng, M.D.
Role: primary
Ke Mingyao, M.D.
Role: primary
Wu Lin, M.D.
Role: primary
Yu Jingrui, M.D.
Role: primary
Pan Minghong, M.D.
Role: primary
Zhou Jianying, M.D.
Role: primary
Huang Jianjin, M.D.
Role: primary
Zhang Yi Ping, M.D.
Role: primary
Lu Li Qin, M.D.
Role: primary
Guo Jianxin, M.D.
Role: primary
Shen Weiyu, M.D.
Role: primary
Hu Wei, M.D.
Role: primary
Li Wenfeng, M.D.
Role: primary
Other Identifiers
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BD-IV-43
Identifier Type: -
Identifier Source: org_study_id