Clinical trial · Interventional
Nasopharyngeal Carcinoma (NPC) Axitinib
Phase 2 Study of Axitinib in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma
NCT01249547CI-TRIAL-00027184completedPhase 2ClinicalTrials.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 is an open-label, single arm, phase 2 clinical trial evaluating the activity and safety of single-agent axitinib in recurrent or metastatic NPC patients who failed at least one line of platinum based chemotherapy.
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 |
|---|---|---|---|
| Recurrent or Metastatic NPC | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| axitinib | Drug | Axitinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- axitinib arm
- interventionNames
- Drug: axitinib
Primary outcomes (1)
- measure
- To evaluate the efficacy (clinical benefit rate) of single-agent axitinib in patients with recurrent or metastatic NPC, and its impact on disease progression.
- timeFrame
- 3 years
Secondary outcomes (7)
- measure
- To assess objective response rate
- timeFrame
- 3 years
- measure
- To assess duration of response
- timeFrame
- 3 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed diagnosis of nasopharyngeal carcinoma (NPC) (either at initial diagnosis or at recurrence). * Patients with recurrent or metastatic NPC that has progressed following one line of prior platinum-based chemotherapy. * Disease must be not amenable to potentially curative radiotherapy or surgery. * Measurable disease according to RECIST. * Age 18 or above; ECOG performance 0 or 1. * Adequate bone marrow, renal and hepatic reserve. Exclusion Criteria: * Presence of local recurrence * Presence of neck lymph node recurrence invading vascular structure; * Presence of central lung lesions involving major blood vessels; * History of hemoptysis or epistaxis within 4 weeks; * Preexisting uncontrolled hypertension defined as more than 140/90 mmHg despite adequate medical therapy; * Gastrointestinal abnormalities, including inability to take oral medication or malabsorption syndrome; * Concurrent use or anticipated need for treatment with known potent CYP3A4 inhibitors or CYP3A4 /CYP1A2 inducers.
References
Publications (0)
Data not yet available
No reference posted for this study.