phase i study of chiauranib in patients with advanced solid tumors

Conditions: Solid Tumors

Summary: the purpose of this dose-escalation study is to assess the safety and tolerability of treatment with chiauranib administered orally over a range of doses in patients with advanced solid tumors.

the purpose of this study is to assess the tolerability and safety include adverse events, vital signs, laboratory tests ,etc., of a range of doses of chiauranib in solid tumor patients, and to determine the dose limit toxicity and the maximum tolerable dose.

Eligibility criteria:
inclusion criteria: 1. histological or cytological confirmation of advanced solid tumor, including non-small cell lung cancer, colorectal cancer, ovarian cancer, renal cell carcinoma, gastrointestinal stromal tumor, gastric cancer, et al; 2. patients with advanced solid tumors refractory to standard therapy or for which no standard therapy exists; 3. body mass index (bmi) is between 18 and 28; 4. age: 18\~65 years; 5. eastern cooperative oncology group (ecog) performance status of 0 or 1; 6. laboratory criteria are as follows: 1. complete blood count: hemoglobin (hb) ≥100g/l (no blood transfusion within 14 days); absolute neutrophil count (anc) ≥1.5×109/l ; platelets \>=100×109/l 2. biochemistry test: serum creatinine \<=1.5×upper limit of normal (uln); total bilirubin≦1.5×uln; alanine aminotransferase / aspartate aminotransferase≦1.5×uln; fasting triglyceride (tg) \<= 3.0 mmol/l; total cholesterol \<= 7.75 mmol/l 3. coagulation test: international normalized ratio (inr) \< 1.5 7. women of child-bearing potential should be non-lactating patients, and must agree to use effective contraceptive methods prior to study entry, during study participation, and up to 6 months following completion of therapy. a serum or urine pregnancy test within 7 days before enrollment must be negative; men must agree to use effective contraceptive methods during study participation and up to 6 months following completion of therapy; 8. willingness to sign a written informed consent document exclusion criteria: 1. life expectation \< 3 months; 2. subjects received anti-cancer therapy (including chemotherapy, radiotherapy, targeted therapy and endocrine therapy, et al) within 4 weeks prior to study entry; subjects received nitrosoureas or mitomycin chemotherapy within 6 weeks prior to study entry; 3. have uncontrolled or significant cardiovascular disease, including: 1. myocardial infarction (\< the last 12 months) 2. uncontrolled angina (\< the last 6 months) 3. congestive heart failure (\< the last 6 months), or left ventricular ejection fraction (lvef) \< 50% prior to study entry 4. history of any significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, or tdp) 5. history of significant qt interval prolongation, or corrected qt interval (qtc) \> 450 ms prior to study entry 6. history of cerebrovascular accident 7. symptomatic coronary heart disease requiring treatment with agents 8. uncontrolled hypertension (\> 140/90 mmhg) by single agent; 4. have active bleeding , current thrombotic disease, or patients with bleeding potential receiving anticoagulation therapy; 5. history of deep vein thrombosis or pulmonary embolism; 6. have unsolved toxicities (\> grade 1) from prior anti-cancer therapy; 7. have clinical significant gastrointestinal abnormality, e.g., unable to swallow, chronic diarrhea, ileus, that would impair the ingestion,transportation or absorption of oral agents, or patients undergone gastrectomy; 8. have symptomatic brain metastasis; 9. history of organ transplantation; 10. proteinuria positive; 11. congenital or acquired immunodeficiency, active infections; 12. any mental or cognitive disorder, that would impair the ability to understand the informed consent document or the operation and compliance of study; 13. any other condition which is inappropriate for the study in the opinion of the investigators.

Keywords: chiauranib, advanced solid tumors, phase 1 study