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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03591666
Other study ID # 2018HNRT02
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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