advanced solid tumors
Conditions
Interventions
50 mg:Larotinib Mesylate Capsule 50 mg once daily
100 mg:Larotinib Mesylate Capsule 100 mg once daily
150 mg:Larotinib Mesylate Capsule 150 mg once daily
220 mg:Larotinib Mesylate Capsule 220 mg once daily
300 mg:Larotinib Mesylate Capsule 300 mg once daily
400 mg:Larotinib Mesylate Capsule 400 mg once daily
500 mg:Larotinib Mesylate Capsule 500 mg once daily
600 mg:Larotinib Mesylate Capsule 600 mg once daily
Sponsors
Jilin university first hosptal
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Female or male, between 18 to 75(both inclusive) years of age; 2. Having a Body Mass Index (BMI) between 18 to30 (both inclusive), calculated as weight in kg/height in m2; 3. Histologically confirmed advanced malignancies refractory to standard of care therapy, or for whom no standard of care therapy is available. Subjects Is willing to provide pre-existing diagnostic or resected tumor samples, such as formalin-fixed paraffin-embedded sections.Providing a fresh tumor biopsy sample is optional; 4. Remission from prior radiotherapy, chemotherapy or surgical procedures toxic effects (NCI CTCAE4.0 grade =12 weeks; 7. Solid tumors must have measurable lesion as per Response Evaluation Criteria in Solid Tumors (RECIST v.4.0); 8. Adequate organ function as defined by the following criteria: (1) Has adequate bone marrow function, defined as: absolute neutrophil count (ANC) >=1.5*10^9/L(do not need growth factor treatment), white blood cell count(WBC) >=3.0*10^9/L, platelets>=70*10^9/L, hemoglobin>=90 g/L; (2) Has adequate hepatic function, defined as: serum aspartate transaminase (AST) andserum alanine transaminase (ALT) =60 mL/min; 9. Subject Consent: (1) Signed anddated informed consent document indicating that the patient (or legally authorised representative) has been informed of all the pertinent aspects of the trial prior to performing this study; (2) Willingness andability to comply with scheduled visits, treatment plans, laboratory tests, andother study procedures.
Exclusion criteria
Exclusion criteria: Patients with any of the following treatment history will be excluded: 1. Major surgery, radiation therapy, chemotherapy, immunotherapy, or hormone therapy within 4 weeks before study treatment; 2. Prior-treatment with chemotherapy such asanthracycline, nitrosoureas or mitomycin within 6 weeks; 3. Received any licensed live vaccine within 4 weeks prior to the study treatment or plan to receive the vaccine after attending to the study; 4. Prior-treatment with other anticancer drugs including EGFR Tyrosine Kinase Inhibitors within 4 weeks before study drug treatment; 5. Be in other clinical trials currently; 6. Life expectancy 450 msec for male andQTc interval>470 msec for female (QTc=QT/RR0.33 under Fridericia corrected formulation); 7. Any serious or uncontrollable disease concomitant systemic disorder (such as unstable respiratory, cardiovascular, digestive, endocrine or urinary disorders) within the 6 months prior to the study screening includingbutnotlimited to active tuberculosis, acute myocardial infarction, severe or unstable angina, congestive heart failure, torsade de pointes, uncontrolled hypertension, cerebrovascular accident including transient ischemic, diabetes; 8. Within 6 months prior to the study treatment for pulmonary embolus, except advanced malignant pulmonary embolus patients confirmed by the investigator andsponsor. Appropriate anticoagulants treatment is permitted; 9. Gastrointestinal diseases that could affect the absorption of Z650, (e.g., significant gastrointestinal disorder (s), chronic diarrhea, bowel obstruction); 10. Patients with obvious hemorrhagic tendency in gastrointestinal system, including localized active ulcer lesion with occult blood, melena andhaematemesis within 2 months prior to treatment;digestive tract hemorrhageoccurred that may affect the study treatment; 11. Known acquired or congenital immunodeficiency, or organ transplantation; 12. History of interstitial lung disease; drug-induced
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| safety;Pharmacokinetic profile;ORR;DCR;Biomarks;PFS; | — |
Countries
China
Contacts
Public ContactWang Zhaohe
Outcome results
None listed