Recurrent or Metastatic NPC
Conditions
Brief summary
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.
Interventions
DRUGaxitinib
starting dose of 5 mg twice daily for 4 consecutive weeks without interruption.
Sponsors
Chinese University of Hong Kong
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| To assess duration of response | 3 years |
| To assess progression-free survival | 3 Years |
| To assess overall survival | 3 Years |
| To assess objective response rate | 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 |
| To evaluate the safety and tolerability of axitinib | 3 years |
Countries
Hong Kong
Outcome results
None listed