Advanced Cancer
Conditions
Brief summary
This study is conducted to assess the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT), to evaluate the pharmacokinetics, safety and preliminary anti-tumor activity of Sinotecean.
Interventions
DRUGSinotecean
Sponsors
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* late malignant tumor patients diagnosed with the pathological and/or cytological; * lack of the standard treatment or treatment failure; * 18-65years, ECOG:0-1,expected survival period \>3 months; * main organs function is normal; * signed and dated informed consent
Exclusion criteria
* participated in other clinical trials in four weeks; * currently under other effective treatment; * end of anti-tumor treatment within 4 weeks(end of Nitrosourea/Mitomycin within 6 weeks); * AE ≥ Grade 2(according to NCI-CTC 4.0),except hair loss; * with ischemic heart disease, heart failure, severe arrhythmia, cerebrovascular disease, asthma, severe infections, active peptic ulcer; * urine protein: ++, and urinary in 24 hours \> 1.0g; * uncontrolled primary or metastatic brain; * have immunodeficiency history; * according to the researcher's judgment,there are concomitant diseases which will seriously endanger the patients or obstruct the patients to complete the clinical trial;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic Assessments for Area Under Curve（AUC） | Day 1-2 Single Dose | To collect point with single drug:5 min/10 min/15 min/30 min/1 h/2h/4h/6 h/8h/10h/12 h/24 h/32h/48 h |
| Pharmacokinetic Assessments for Cmax | Day 1-2 Single Dose | — |
| Pharmacokinetic Assessments for Tmax | Day 1-2 Single Dose | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate （ORR) | each 42 days up to intolerance the toxicity or progression of disease（PD） (up to 24 months) |
| Maximum tolerated dose(MTD) | up to 24 months |
| Dose-limiting toxicity(DLT) | up to 24 months |
Countries
China
Contacts
Primary ContactShusen Wang, doctor
Outcome results
None listed