Nasopharyngeal Carcinoma
Conditions
Keywords
nasopharyngeal carcinoma,donafeinib
Brief summary
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.
Detailed description
The study is an open-label, phase 1B study recruiting 18 patients. Patients were eligible to participate when they have histological or cytological documentation of the nasopharyngeal carcinoma. They must have received locally and currently approved standard therapies and to have disease progression after the last administration of the last standard therapy or to have stopped standard therapy because of unacceptable toxic effects. The available standard therapies have to include one or more drugs of the following as were licensed: a fluoropyrimidine,taxane,DDP, gemcitabine. Patients have to be aged 18 years or older and have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; life expectancy of at least 3 months;and adequate bone-marrow, liver, and renal function at the start of the trial. Patients could not participate if they had previously received sorafenib or had uncontrolled medical disorders. All patients receive best supportive care, excluding other investigational antitumour agents or antineoplastic chemotherapy, hormonal therapy, or immunotherapy.Patients receive oral donafenib 200mg (CM4307) of each 4 week cycle until disease progression,death, unacceptable toxic effects, withdrawal of consent by the patient,or decision by the treating physician that discontinuation would be in the patient's best interest.The primary endpoint is safety.The second endpoint is progression-free survival.
Interventions
DRUGDonafenib
donafenib 200mg，bid
Sponsors
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
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
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with Adverse Events | 2 years | Percent of adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival | 2 years | Median of progression of free survival |
| Response Rate | 1 year | Percent of patients of PR&CR |
Countries
China
Outcome results
None listed