NCT02122809CompletedPhase 1
Phase I Safety and Pharmacokinetics Study of Chiauranib in Patients With Advanced Solid Tumors
Chipscreen Biosciences, Ltd.1 site in 1 country18 target enrollmentStarted: February 2014Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- dose-limiting toxicity (DLT)
Study Overview
Brief 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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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;
- •Patients with advanced solid tumors refractory to standard therapy or for which no standard therapy exists;
- •Body mass index (BMI) is between 18 and 28;
- •Age: 18~65 years;
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
- •Laboratory criteria are as follows:
- •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
- •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
- •Coagulation test: International Normalized Ratio (INR) < 1.5
- •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;
- •Willingness to sign a written informed consent document
Exclusion Criteria
- •Life expectation < 3 months;
- •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;
- •Have uncontrolled or significant cardiovascular disease, including:
- •Myocardial infarction (< the last 12 months)
- •Uncontrolled angina (< the last 6 months)
- •Congestive heart failure (< the last 6 months), or Left Ventricular Ejection Fraction (LVEF) < 50% prior to study entry
- •History of any significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, or TdP)
- •History of significant QT interval prolongation, or Corrected QT Interval (QTc) > 450 ms prior to study entry
- •History of cerebrovascular accident
- •Symptomatic coronary heart disease requiring treatment with agents
- •Uncontrolled hypertension (> 140/90 mmHg) by single agent;
- •Have active bleeding , current thrombotic disease, or patients with bleeding potential receiving anticoagulation therapy;
- •History of deep vein thrombosis or pulmonary embolism;
- •Have unsolved toxicities (> grade 1) from prior anti-cancer therapy;
- •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;
- •Have symptomatic brain metastasis;
- •History of organ transplantation;
- •Proteinuria positive;
- •Congenital or acquired immunodeficiency, active infections;
- •Any mental or cognitive disorder, that would impair the ability to understand the informed consent document or the operation and compliance of study;
- •Any other condition which is inappropriate for the study in the opinion of the investigators.
Arms & Interventions
Chiauranib
Experimental
Patients take a single dose of Chiauranib capsules for the pharmacokinetic study,then off for 5 days before the first cycle begins. In the subsequent treatment cycles, Chiauranib capsules are given orally once daily, 28 days as a cycle.
Intervention: Chiauranib (Drug)
Outcomes
Primary Outcomes
dose-limiting toxicity (DLT)
Time Frame: day 1-28
Number of Adverse Events
Time Frame: An expected average of 8 months
Secondary Outcomes
- pharmacokinetic profile of Chiauranib(On day 1,8,15,22,25,26,27,28)
- Pharmacodynamic profile of Chiauranib(On day 15,28)
- Evidence of benefit(An expected average of 8 months)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 1
Chiauranib in Combination With Chidamide in Patients With Relapsed/Refractory Non-Hodgkin's LymphomaNon-hodgkin's LymphomaNCT03974243Chipscreen Biosciences, Ltd.9
Completed
Phase 1
A Study of LY3532226 in Participants With ObesityObesityNCT06557356Eli Lilly and Company132
Completed
Phase 1
Phase 1 Study of CM082 (X-82) Tablets in Advanced Cancer Patients in ChinaAdvanced CancerNCT01863485AnewPharma44
Terminated
Phase 2
Study Exploring Safety, Pharmacokinetic and Pharmacodynamic of BN82451 in Male Huntington's Disease PatientsHuntington's DiseaseNCT02231580Ipsen17
Completed
Phase 1
A Study of PLX2853 in Advanced Malignancies.Uveal MelanomaNon-Hodgkin LymphomaAdvanced MalignanciesSolid TumorDiffuse Large B Cell LymphomaSmall Cell Lung CancerFollicular LymphomaOvarian Clear Cell CarcinomaNCT03297424Opna Bio LLC49