A Study of Sinotecean on Tolerance and Pharmacokinetics

CTTQ

Status and phase

Unknown

Phase 1

Conditions

Advanced Cancer

Treatments

Drug: Sinotecean

Study type

Interventional

Funder types

Industry

Identifiers

NCT02469883

XNTK-I-03

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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;