Nasopharyngeal Carcinoma (NPC) Axitinib

Study Overview
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Brief Summary
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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.

Official Title
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Phase 2 Study of Axitinib in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma

Conditions
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Recurrent or Metastatic NPC

Intervention / Treatment
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* Drug: axitinib


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: axitinib arm<br> | Drug: axitinib<br>* starting dose of 5 mg twice daily for 4 consecutive weeks without interruption.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the efficacy (clinical benefit rate) of single-agent axitinib in patients with recurrent or metastatic NPC, and its impact on disease progression. |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess objective response rate |  | 3 years | 
| To assess duration of response |  | 3 years | 
| To assess progression-free survival |  | 3 Years | 
| To assess overall survival |  | 3 Years | 
| To evaluate the safety and tolerability of axitinib |  | 3 years | 
| To evaluate axitinib plasma pharmacokinetics and to correlate these plasma concentrations with efficacy and safety parameters |  | 3 years | 
| To study blood and tissue biomarkers and correlate with cancer- and treatment-related outcomes |  | 3 years |