Nasopharyngeal Carcinoma
Conditions
Brief summary
This is a phase 2 study to evaluate the efficacy of single-agent icotinib in patients with advanced nasopharyngeal carcinoma.
Detailed description
This phase 2 study is aimed to evaluate the efficacy of single-agent icotinib in patients with pretreated, advanced nasopharyngeal carcinoma. The primary endpoint is disease control rate (DCR).
Interventions
DRUGIcotinib
Icotinib (125 mg tablet) is orally administered three times daily until disease progression or unaccepted toxicity.
Sponsors
Betta Pharmaceuticals Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed advanced NPC * Patients must be platinum-resistant defined as recurrence or progression of disease \<6 months since previous treatment with a platinum based treatment regimen. * Measurable disease per RECIST * Adequate organ and marrow function * Capable of understanding and complying with the protocol, and written informed consent
Exclusion criteria
* Prior treatment with gefitinib, erlotinib, or other drugs that target EGFR * Patients must not be receiving any other investigational agents * Other serious illness or medical condition including unstable cardiac disease requiring treatment, history of significant neurologic or psychiatric disorders (including psychotic disorders, dementia, or seizures), or active uncontrolled infection * Women who are pregnant or breast-feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease control rate(DCR) | At least 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival | At least 8 weeks |
Outcome results
None listed