Advanced Solid Tumor
Conditions
Interventions
Study group 1 :R01 40mg, po, qd
Study group 2:R01 80mg, po, bid
Study group 3:R01 80mg, po, tid
Study group 4:R01 120mg, po, bid
Study group 5:R01 120mg, po, tid
Study group 6:R01 160mg, po, tid
Sponsors
The Fifth Medical Center of Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Patients must meet all of the following inclusion criteria to be enrolled in this study: (1) Age: > = 18 years old, and =1500/mm³(1.5×10^9/L); b.Platelet >=750000/mm³(75×10^9/L); c.Hemoglobin > = 9 g/dL (90 g/L); d.Both ALT and AST were <=2.5× ULN, and ALT and AST were <=5.0× ULN in liver metastasis. e.Total bilirubin (TBIL) <=1.5×ULN; f. Serum creatinine < = 1.5×ULN or estimated creatinine clearance =50 mL/min (according to Cockcroft and Gault formula). (7) Resolution of all acute toxicities from prior anticancer therapy or surgical procedures to baseline severity or NCI CTCAE version 5.0<=Grade 1 (except for alopecia or other toxicities that the investigator considers not to be a safety risk to the patient); (8) After a comprehensive understanding, willing to sign the informed consent form.
Exclusion criteria
Exclusion criteria: Patients with any of the following cannot be enrolled in this study: (1) Advanced patients with a short-term risk of life-threatening complications (patients with visceral crisis); (2) Known or symptomatic active CNS metastases manifested by the presence of clinical symptoms, cerebral edema, spinal cord compression, carcinomatous meningitis, leptomeningeal disease, and/or progressive growth; (3) Major surgery, chemotherapy, radiation therapy, any investigational drugs, or other anti-cancer therapy within 4 weeks prior to study entry; (4) Those who have not withdrawn from other clinical trials within 4 weeks before entering the study; (5) Known history of allergy or suspected allergic symptoms to any component of R01 powder; (6) Within 7 days prior to study entry, the patient has received the following treatments: drugs known to be strong inhibitors/inducers of CYP; Drugs known to significantly prolong the QT interval. (7) In the resting state, the average corrected QT interval (QTc) obtained by 3 electrocardiogram (ECG) examinations was > 480 msec (only when the first ECG showed QTc > 480 msec, it was necessary to retest and take the average corrected value for 3 times); History of long QT syndrome or confirmed family history of long QT syndrome; History of clinically significant ventricular arrhythmias, or current use of antiarrhythmic drugs or defibrillation devices implanted in the body for the treatment of ventricular arrhythmias; (8) uncontrolled electrolyte imbalances that may affect the effect of prolonging QTc drugs (such as hypocalcemia =2 persistent arrhythmia, atrial fibrillation of any grade, coronary/peripheral artery bypass grafting, symptomatic congestive heart failure, cerebrovascular accident (including transient ischemic attack or symptomatic pulmonary embolism), myocardial infarction or coronary/peripheral artery bypass grafting within 6 months; (10) Clinically significant active infection of the following, including hepatitis B (HBV), hepatitis C (HCV), known human immunodeficiency virus (HIV), or acquired immunodeficiency syndrome (AIDS)-related diseases. Active hepatitis B is defined as: hepatitis B surface antigen (HBsAg) and/or hepatitis B e antigen (HBeAg) positive with HBV-DNA >= 2000 IU/ml (equivalent to 104 copies/ml); Active hepatitis C is defined as HCV RNA above the upper limit of detection; (11) Other severe acute or chronic medical or psychiatric conditions or laboratory abnormalities that may increase the risk of participating in the study or increase the risks associated with the administration of the study drug, or interfere with the results of the study, and other conditions that the investigator considers the patient to be unsuitable for participation in this study; (12) Diabetes mellitus with poor glycemic control; (13) Males and females who plan to have another child within 5 years without in vitro preservation of sperm or egg cells; (14) Have recent or active suicidal ideation or behavior.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse event; | — |
Secondary
| Measure | Time frame |
|---|---|
| PK parameter;Objective relief rate, ORR;Progression free survival, PFS;Disease control rate, DCR;During of response, DOR; | — |
Countries
China
Contacts
Public ContactGuanghai Dai
The Fifth Medical Center of Chinese PLA General Hospital
Outcome results
None listed