Clinical trial NCT02698111: Donafenib Monotherapy for Previously Treated Metastatic Nasopharyngeal Carcinoma
Official title: Donafenib Monotherapy for Previously Treated Metastatic Nasopharyngeal Carcinoma：an Open-label,Phase 1 Study.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Nasopharyngeal Carcinoma
Keywords: nasopharyngeal carcinoma,donafeinib
Lead sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2016-03-03
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants with Adverse Events
timeFrame: 2 years
Secondary outcomes:
measure: Progression Free Survival
timeFrame: 2 years
measure: Response Rate
timeFrame: 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital of Medical College
state: Beijing
Study officials:
affiliation: Cancer Hospital Chinese Academy of Medical Sciencess
name: Yuan Kai Shi, Doctor
role: PRINCIPAL_INVESTIGATOR
References: