A Study of Anlotinib in Recurrent/Metastatic Head and Neck Adenocarcinomas

Adenocarcinoma Clinical Trial

Official title:

A Non-randomized Phase II Study of Anlotinib in Recurrent/Metastatic Head and Neck Adenocarcinomas

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03591666
• Other study ID #: 2018HNRT02
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: July 15, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: July 2018
• Source: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
• Contact: Shengjin Dou
• Phone: +8615800386875
• Email: doushengjin[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a non-randomized, phase II, open label study of anlotinib hydrochloride capsules in recurrent/metastatic adenocarcinomas of head and neck. The primary purpose of this study is to evaluate the efficacy of anlotinib.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 51
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Histologically or cytologically confirmed head and neck adenocarcinoma.

2. Patients with recurrent or metastatic head and neck adenocarcinoma who are not candidates for curative surgery or radiotherapy.

3. Measurable disease per the RECIST criteria.

4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.

5. Provision of written informed consent.

6. Childbearing potential either terminated by surgery, radiation, or menopause, or attenuated by use of an approved contraceptive method (IUD, birth control pills, or barrier device) during and for 3 months after completion of trial therapy.

Exclusion Criteria:

1. Prior treatment with Anlotinib

2. With pleural effusion or ascites, cause respiratory syndrome

3. Accepted the vascular endothelial growth inhibitor class targeted drug treatment of patients

4. Plan to take systemic anti-tumor therapy within 4 weeks before grouping or during the medicine-taking period of this research, including Cytotoxic Therapy, 5.Signal Transduction Inhibitor, and Immunotherapy (or who use Mitomycin C within 6 weeks before taking the treatment with experimental drug); The patients who have already taken Extended Field Radiotherapy (EF-RT) within 4 weeks before grouping or Limited Field Radiotherapy with proposed assessment of nidus within 2 weeks before grouping

6.Symptoms of brain metastases cannot be controlled and treated within less than 2 months 7.severe and failed to controlled diseases 8.Occurred venous thromboembolic events within 6 months

Related Conditions & MeSH terms

• Adenocarcinoma
• Distantly Metastatic Malignant Neoplasm
• Head and Neck Carcinoma
• Neoplasms
• Neoplasms, Second Primary
• Recurrent Disease

Intervention

Drug:
• Anlotinib
Anlotinib p.o. qd

Locations

Country	Name	City	State
China	Shanghai ninth people's hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate (ORR)		up to 24 months
Secondary	Progress free survival (PFS)		up to 24 months
Secondary	Disease Control Rate (DCR)		up to 24 months
Secondary	Overall Survival (OS)		up to 24 months