various cancer patients, mainly in advanced non-small cell lung cancer patients
Conditions
Interventions
150mg:Oral dosing icotinib tablets, Tid, in continuing 28 days, to assess the safety, tolerance and pharmacokinetics of icotinib. The drug was continued after 28days until documented progressive disea
200mg:Oral dosing icotinib tablets, Tid, in continuing 28 days, to assess the safety, tolerance and pharmacokinetics of icotinib. The drug was continued after 28days until documented progressive disea
75mg:Oral dosing icotinib tablets, Tid, in continuing 28 days, to assess the safety, tolerance and pharmacokinetics of icotinib. The drug was continued after 28days until documented progressive diseas
250mg:Oral dosing icotinib tablets, Tid, in continuing 28 days, to assess the safety, tolerance and pharmacokinetics of icotinib. The drug was continued after 28days until documented progressive disea
125mg:Oral dosing icotinib tablets, Tid, in continuing 28 days, to assess the safety, tolerance and pharmacokinetics of icotinib. The drug was continued after 28days until documented progressive disea
100mg:Oral dosing icotinib tablets, Tid, in continuing 28 days, to assess the safety, tolerance and pharmacokinetics of icotinib. The drug was continued after 28days until documented progressive disea
Sponsors
The First Affiliated Hospital, College of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. The patients with advanced solid tumors (including non-small cell lung cancer, pancreatic cancer, liver cancer, colorectal cancer, head and neck cancer, etc.) who are confirmed by histological or cytological diagnosis, previously treated at least one chemotherapy regimen (other than EGFR). The diseases relapse, ineffective, lack of effective conventional treatment or in stable stage; 2. Received cytotoxic chemotherapy drugs. And the end of chemotherapy treatment is at least four weeks from this registration to participate in this test. The subject must have recovered from any previous chemotherapy toxicity. The treatment must stop for more than three months, if it includes docetaxel or lung radiotherapy; 3. Patients with at least one measurable lesion meeting RECIST: ?At least one measurable lesion. Histology and/or cytology diagnosis will be necessary if patients with only one lesion. ?Lesions can be accurately measured in by the following methods: CT-scan of chest or abdomen or Magnetic resonance imaging (MRI), the 1 dimension as >=20 mm with conventional techniques, or as >=10 mm with spiral computed tomography (CT) scan; 4. ECOG Performance Status of 0, 1; and behavior condition integration (PS)=1.5*10^9/L, Platelet count >=90*10^9/L, Hemoglobin >=9 g/dL; (2) Hepatic: bilirubin =60mL/min based on the standard Cockcroft-Gault formula or Serum Creatinine <=1.5 times the upper limit of normal; (4) No malabsorption or other disease which will affect the drug absorption. 8. Female: Women with childbearing potential must have a negative pregnancy test performed within 72 hours prior to treatment, or must use an approved contraceptive method during and for 3 months after the study; must have a negative serum or urine pregnancy test, and must not be breast-feeding'; 9. Male: Must be surgically sterile or compliant with a contraceptive regimen during and for 3 months after the treatment; 10. Patients compliance and geographic proximity that allow adequate follow-up; 11. Ability to understand and the willingness to sign a written informed consent; 12. A signed informed consent must be obtained prior to performing any study specific procedures.
Exclusion criteria
Exclusion criteria: 1. Have received HER/EGFR inhibitor and other molecular target drugs (micromolecular drug or MoAb) in other study, including endostar, Avastin, Iressa, Tarceva, Sutent, Nexavar, Sprycel, Erbitux and Herceptin; 2. Have a known hypersensitivity to icotinib or any of the excipient of icotinib; 3. concurrent treatment with sodium phenytoin, carbamazepine, rifampin, barbital or Sant Jone grass; 4. Have received treatment within the last 30 days with other study drug or a drug that has not received regulatory approval for any indication at the time of study entry; 5. Organ or system status: (1) Known brain metastasis diagnosed recently which have not received surgery or radiotherapy. Patients has been off corticosteroids for at least 4 weeks before start study therapy if have prior CNS metastases or oppressing spinal cord. requiring corticosteroids treatment for unstable status; (2) Have interstitial lung disease; have drug-induced pneumonia; have radiation pneumonia which requires treat with corticosteroids, have active interstitial lung disease evident on clinical evaluation; (3) Have pre-existing idiopathic pulmonary fibrosis as evidenced by CT scan at baseline; (4) Any serious or uncontrollable disease concomitant systemic disorder (such as unstable respiratory disorders, cardiovascular, hepatic or kidney disorders.) judged by the investigator according to evidence; (5) Any unstable systemic disorders(including active infection, hypertension grade IV, unstable angina pectoris, congestive heart failure, liver and kidney disorder or metabolism disease); (6) No other malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or treated cerviccal cancer in situ or squamous Cell Carcinoma of the Skin; (7) Any remarkable eye disorders, especially severe dry eye syndrome, dry kerato- conjunctivitis, Sj'gren syndrome, serious exposition keratitis or other disease that possibly cause damage to epithelia of cornea. Not using contact lens will be better during the study, and whether or not using contact lens will be decided after discussing with oncologist and oculist; (8) Have clinically detectable (by physical exam) third-space fluid collections (for example, ascites or pleural effusions) that cannot be controlled by drainage or other procedures prior to study entry; (9) History of nerve or psychiatric disorder, including epilepsy or dementia. 6. Inadequate organ function including the following: ?Absolute neutrophil (segmented and bands) count (ANC) 1.5*upper limit of normal (ULN); (2) Creatinine>1.5*upper limit of normal (ULN) or calculated creatinine clearance (CrCl) 2.5*ULN if the liver has no tumor involvement, aspartate transaminase (AST) and alanine transaminase (ALT) >5*ULN if the liver has tumor involvement; (4) Lung function disorder confirmed by clinical examination or PaO2=10%), over the previous 6 weeks before study entry; (7) >grade 2 uncured chronic toxic response (except alopecia) according to NCI-CTC (National Cancer Institute Common Terminology Criteria version 2.0); 7. Have previously registration or withdrawn from this study; 8. Life expe
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival;Safety and tolerance; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics, QLQ rating and preliminary observation;Overall Survival, Objective Response Rate, Disease; | — |
Countries
China
Contacts
Public ContactZhao Qiong
Outcome results
None listed