Advanced solid tumor
Conditions
Interventions
Not Applicable:Nil
Sponsors
Cancer Hospital Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Patients who meet all the following inclusion criteria can be enrolled in this study. 1. Age 1870 years old (including 18 and 70). 2. Patients must be histologically or cytologically confirmed diagnosis of advanced malignant solid tumors, including breast cancercolorectal cancer, etc. 3. Patients who have failed standard treatment, or are ineffective /intolerable to standard treatment, or have no effective standard treatment regimens are enrolled. 4. Laboratory results must meet the following requirements (without administration of blood products, cell growth factors, albumin and other drugs within 14 days of laboratory test). Hemoglobin (HGB) >= 90 g/L Absolute neutrophil count(ANC)>= 1.5 x 10^9/L. Platelet count(PLT)>= 75 x 10^9/L. Aspartate aminotransferase(AST)and Alanine aminotransferase(ALT)= 12 weeks. 7. Patients must have at least one measurable lesion (per Response Evaluation Criteria in Solid Tumors [RECIST] 1.1). 8. Male and female of childbearing potential must take effective contraceptive measures after signing the informed consent, during the study and for 1 month (28 days) after last investigational drug dose received. Women of childbearing potential must have a negative serum pregnancy test at screening. 9. Patients should sign written informed consent voluntarily. Patients can communicate well with researchers and comply with relevant research regulations.
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria can not be enrolled in this study. 1. Active (untreated) brain metastasis, cancerous meningitis, spinal cord compression, or computed tomography (CT) or magnetic resonance imaging (MRI) documented the presence of brain or leptomeningeal metastasis at screening. However, patients with brain metastasis may participate in the study, if the patient is with asymptomatic brain metastasis, with brain metastasis that have completed therapy and/or clinically stable within 28 days before first administration of the investigational drug, and do not require steroids or anticonvulsants treatment, and head CT or MRI scan within 28 days before enrollment are required. 2. Diabetes (including history of gestational diabetes). 3. Patients who require systemic corticosteroids (dosage equivalent to > 10 mg prednisone once daily) or other immunosuppressive treatment within 14 days before enrollment or during the study period. 4. Active type B or C hepatitis (HBsAg positive and/or HBcAb positive, and HBV DNA >= 104 copies or >= 4000IU/ml; HCV antibody positive), or human immunodeficiency virus (HIV) antibody positive. 5. Other acquired or congenital immunodeficiency diseases, or with a history of organ transplantation. 6. Skin diseases that require interventional treatment or can influence the evaluation of research indicators. 7. Patients with active peptic ulcer, obvious emesis, chronic diarrhea, intestinal obstruction, malabsorption etc. or other known diseases that influence the absorption of drug. 8. Patients who have received prior treatment with a P13K inhibitor, or are allergic to any investigational drug components or excipients. 9. Patients who are participating in other studies for device/drug, or dropped out from other researches of drugs/ devices 38.5?. 12. Cardiovascular disease with clinical significance (defined as heart failure, cardiomyopathy, uncontrolled coronary heart disease, uncontrolled arrhythmia); a history of myocardial infarction within 6 months before enrollment; ECG QTcF> 480msec in screening period; poorly controlled hypertension with medication (systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg). 13. Patients with severe diseases of respiratory system, digestive system, urinary system, central nervous system or hematological system. 14. Patients whose self-assessment score in Depression Screening Scale (PHQ-9 questionnaire) >= 12 or who choose Answer 2 or 3 for Article 9 about potential suicidal thoughts or intentions (independent of the overall score of PHQ-9); or self-assessment score in the General Anxiety Disorder Scale (GAD-7) >= 15. 15. Patients with a history of mental disorder (such as depression, schizophrenia, etc.) and poor compliance. 16. History of other malignant tumor, with exceptions of radically cured non-melanoma skin cancer, cervical cancer in situ and prostate intraepithelial tumor. I
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerance evaluation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic evaluation;Efficacy evaluation;Exploratory evaluation of pharmacodynamics;Evaluation of exploratory biomarkers; | — |
Countries
China
Contacts
Public ContactTaotao Jiang
Shanghai Haiyan Medical Technology Co., LTD
Outcome results
None listed