Clinical Trial: Donafenib Monotherapy for Previously Treated Metastatic Nasopharyngeal Carcinoma
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
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 Summary:
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.
Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Current Primary Outcome: Number of participants with Adverse Events [ Time Frame: 2 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Progression Free Survival [ Time Frame: 2 years ]
- Response Rate [ Time Frame: 1 year ]
Original Secondary Outcome: Same as current
Information By: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Dates:
Date Received: February 29, 2016
Date Started: November 2016
Date Completion: December 2018
Last Updated: October 12, 2016
Last Verified: October 2016
