Brief Title
Donafenib Monotherapy for Previously Treated Metastatic Nasopharyngeal Carcinoma
Official Title
Donafenib Monotherapy for Previously Treated Metastatic Nasopharyngeal Carcinoma：an Open-label,Phase 1 Study.
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.
Study Phase
Phase 1/Phase 2
Study Type
Interventional
Primary Outcome
Number of participants with Adverse Events
Secondary Outcome
Progression Free Survival
Condition
Nasopharyngeal Carcinoma
Intervention
Donafenib
Study Arms / Comparison Groups
Donafeinib
Description: donafenib 200mg,bid
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
18
Start Date
November 20, 2016
Completion Date
September 2023
Primary Completion Date
June 2023
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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Yuan Kai Shi, Doctor, 010-87788162, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT02698111
Organization ID
ZGDN1B
Responsible Party
Sponsor
Study Sponsor
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Study Sponsor
Yuan Kai Shi, Doctor, Principal Investigator, Cancer Hospital Chinese Academy of Medical Sciencess
Verification Date
October 2020