Clinical trial · Interventional
A Study of Sinotecean on Tolerance and Pharmacokinetics
A Phase I Study of Sinotecean on Tolerance and Pharmacokinetics
NCT02469883CI-TRIAL-00018253unknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sinotecean | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Sinotecean
- interventionNames
- Drug: Sinotecean
Primary outcomes (3)
- measure
- Pharmacokinetic Assessments for Area Under Curve（AUC）
- timeFrame
- Day 1-2 Single Dose
- description
- 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
- measure
- Pharmacokinetic Assessments for Cmax
- timeFrame
- Day 1-2 Single Dose
- measure
- Pharmacokinetic Assessments for Tmax
- timeFrame
- Day 1-2 Single Dose
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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;
References
Publications (0)
Data not yet available
No reference posted for this study.