Donafenib Monotherapy for Previously Treated Metastatic Nasopharyngeal Carcinoma

NCT02698111 | Terminated Phase 1

• 1 other identifier: ZGDN1B
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Nasopharyngeal Carcinoma

Keywords

nasopharyngeal carcinoma,donafeinib

Outcome Measures

Primary Outcomes (1)

• Number of participants with Adverse Events

  Percent of adverse events

  2 years

Secondary Outcomes (2)

• Progression Free Survival

  2 years

• Response Rate

  1 year

Study Arms (1)

Donafeinib

EXPERIMENTAL

donafenib 200mg,bid

Drug: Donafenib

Interventions

Donafenib DRUG

donafenib 200mg，bid

Also known as: CM4307

Donafeinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients have prior treatment with sorafenib;
• Patients have Central nervous system(CNS) involvement;
• patients have uncontrolled medical disorders.

Sponsors & Collaborators

• Suzhou Zelgen Biopharmaceuticals Co.,Ltd: lead

Study Sites (1)

Cancer Hospital of Medical College

Beijing, Beijing Municipality, 100021, China

Location

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

donafenib

Condition Hierarchy (Ancestors)

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; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Study Officials

• Yuan Kai Shi, Doctor

  Cancer Hospital Chinese Academy of Medical Sciencess

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 29, 2016
• First Posted: March 3, 2016
• Study Start: February 8, 2017
• Primary Completion: October 20, 2021
• Study Completion: October 20, 2021
• Last Updated: May 8, 2023

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)