Donafenib Monotherapy for Previously Treated Metastatic Nasopharyngeal Carcinoma

NCT ID: NCT02698111

Last Updated: 2023-05-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-08
• Study Completion Date: 2021-10-20

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.

Conditions

Nasopharyngeal Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Donafeinib

donafenib 200mg,bid

Group Type: EXPERIMENTAL

Donafenib

Intervention Type: DRUG

donafenib 200mg，bid

Interventions

Donafenib

donafenib 200mg，bid

Intervention Type: DRUG

Other Intervention Names

CM4307

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yuan Kai Shi, Doctor

Role: PRINCIPAL_INVESTIGATOR

Cancer Hospital Chinese Academy of Medical Sciencess

Locations

Cancer Hospital of Medical College

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

ZGDN1B

Identifier Type: -

Identifier Source: org_study_id