Clinical trial · Interventional
Donafenib Monotherapy for Previously Treated Metastatic Nasopharyngeal Carcinoma
Donafenib Monotherapy for Previously Treated Metastatic Nasopharyngeal Carcinoma：an Open-label,Phase 1 Study.
NCT02698111CI-TRIAL-00066226terminatedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Corporate policy adjustments
Summary
Brief summary (as posted)
The investigators do the clinical trial (patients with metastatic nasopharyngeal carcinoma treated with donafenib after failure of standard therapy) to assess safety and efficacy of donafenib in patients with metastatic nasopharyngeal carcinoma, progressing after all approved standard therapies.
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 |
|---|---|---|---|
| Nasopharyngeal Carcinoma | Nasopharyngeal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Donafenib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Donafeinib
- description
- donafenib 200mg,bid
- interventionNames
- Drug: Donafenib
Primary outcomes (1)
- measure
- Number of participants with Adverse Events
- timeFrame
- 2 years
- description
- Percent of adverse events
Secondary outcomes (2)
- measure
- Progression Free Survival
- timeFrame
- 2 years
- description
- Median of progression of free survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Have histological or cytological documentationof the nasopharyngeal carcinoma; * Have received system standard therapies and to have disease progression(RECIST1.1) or to have stopped standard therapy because of unacceptable toxic effects. * Standard therapies including as many of the following as were licensed: a fluoropyrimidine,taxol,DDP,or gemcitabine; * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; * Life expectancy of at least 3 months; * Have adequate bone-marrow, liver, and renal function at the start of the trial. • Prothrombin time international normalized ratio≤2；or prothrombin time≤16 seconds;or activated partial thromboplastin time(APTT) ≤43 seconds;or TT≤21 seconds. Exclusion Criteria: * Patients have prior treatment with sorafenib; * Patients have Central nervous system(CNS) involvement; * patients have uncontrolled medical disorders.
References
Publications (0)
Data not yet available
No reference posted for this study.