Clinical trial · Interventional
A Study of Tafetinib in Chinese Patients With Advanced Solid Tumor
A Phase I Study to Determine the Safety and Pharmacokinetic Study of Tafetinib in Patients With Advanced Solid Tumors
NCT02717741CI-TRIAL-00021484unknownPhase 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)
Tafetinib is an oral multitargeted tyrosine kinase inhibitor that inhibits Vascular Endothelial Growth Factor Receptor (VEGFR). This phase I trial was conducted to evaluate the pharmacokinetics (PK), safety, and preliminary efficacy of tafetinib in Chinese patients with advance solid tumor. The study are conducting in Cancer Hospital Chinese Academy of Medical Sciences.
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 |
|---|---|---|---|
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| tafetinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- tafetinib
- description
- tafetinib administered daily for 2 weeks, followed by a 1-week off period
- interventionNames
- Drug: tafetinib
Primary outcomes (1)
- measure
- Dose-limiting toxicity
- timeFrame
- 3 weeks
- description
- Dose-limiting toxicity was defined as any one of the following (NCI-CTCAE Version 4.0): (a) hypertension: uncontrollable grade 3 hypertensive or grade 4. (b) reduced LVEF: 2 degrees or above. (c) neutropenia : 3 degrees or above. (d) thrombopenia: 3 degrees or above. (e) Other Non-hematologic toxicity (not including alopecia, nausea or vomiting): 3 degrees or above.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Adult patients with histologically confirmed advanced solid malignancies. * ECOG score 0-1. * 18-65 years old. * Withdrawal other chemotherapy drugs more than 30 days. No nitrosoureas or mitomycin C within the previous 6 weeks. * Function of organs must meet the following requirements: * Neutrophil count ≥1500/ul; * AST and ALT≤1.5 times the upper limit of normal (ULN); * Total serum bilirubin≤1.5 times ULN; * Hemoglobin≥90g/L; * Platelet≥100000/ul; * The creatinine in the normal range or creatinine clearance rate ≥60ml/min; * Left ventricular ejection fraction (LVEF) ≥50%; * Females of childbearing age are required to be practicing effective contraceptive measures and to have a negative serum or urine pregnancy test before study. * Written informed consent is obtained. Exclusion Criteria: * included a history of or current brain metastases, clinically significant cardiovascular disease or uncontrolled hypertension.
References
Publications (0)
Data not yet available
No reference posted for this study.