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

Phase 2

• Conditions: Head and Neck Carcinoma; Adenocarcinoma; Recurrent Disease; Distantly Metastatic Malignant Neoplasm
• Interventions: Drug: Anlotinib

• Registration Number: NCT03591666
• Lead Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-07
• Study First Submitted: 2018-07-09
• Study First Submitted QC: 2018-07-09
• Last Update Submitted: 2018-07-09
• Study Start: 2018-07-15
• Study First Posted: 2018-07-19
• Last Update Posted: 2018-07-19
• Primary Completion: 2019-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 51

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study Group	Anlotinib	Anlotinib QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent

Primary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR)	up to 24 months

Secondary Outcome Measures

Name	Time	Method
Progress free survival (PFS)	up to 24 months
Disease Control Rate (DCR)	up to 24 months
Overall Survival (OS)	up to 24 months

Trial Locations

Locations (1)

Shanghai ninth people's hospital; 🇨🇳 Shanghai, Shanghai, China