Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Donafenib Monotherapy for Previously Treated Metastatic Nasopharyngeal Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02698111
Recruitment Status : Recruiting
First Posted : March 3, 2016
Last Update Posted : March 22, 2019
Sponsor:
Information provided by (Responsible Party):
Suzhou Zelgen Biopharmaceuticals Co.,Ltd

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.

Condition or disease Intervention/treatment Phase
Nasopharyngeal Carcinoma Drug: Donafenib Phase 1 Phase 2

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Donafenib Monotherapy for Previously Treated Metastatic Nasopharyngeal Carcinoma:an Open-label,Phase 1 Study.
Actual Study Start Date : November 20, 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Donafeinib
donafenib 200mg,bid
Drug: Donafenib
donafenib 200mg,bid
Other Name: CM4307




Primary Outcome Measures :
  1. Number of participants with Adverse Events [ Time Frame: 2 years ]
    Percent of adverse events


Secondary Outcome Measures :
  1. Progression Free Survival [ Time Frame: 2 years ]
    Median of progression of free survival

  2. Response Rate [ Time Frame: 1 year ]
    Percent of patients of PR&CR



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02698111


Contacts
Layout table for location contacts
Contact: Yuan Kai Shi, Doctor 010-87788162 cancergcp@163.com

Locations
Layout table for location information
China, Beijing
Cancer Hospital of Medical College Recruiting
Beijing, Beijing, China, 100021
Contact: Yuankai Shi, Doctor    01087888293    syuankaipumc@126.com   
Sponsors and Collaborators
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Investigators
Layout table for investigator information
Principal Investigator: Yuan Kai Shi, Doctor Cancer Hospital Chinese Academy of Medical Sciencess

Layout table for additonal information
Responsible Party: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
ClinicalTrials.gov Identifier: NCT02698111     History of Changes
Other Study ID Numbers: ZGDN1B
First Posted: March 3, 2016    Key Record Dates
Last Update Posted: March 22, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Suzhou Zelgen Biopharmaceuticals Co.,Ltd:
nasopharyngeal carcinoma,donafeinib

Additional relevant MeSH terms:
Layout table for MeSH terms
Nasopharyngeal Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Nasopharyngeal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Carcinoma
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases