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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-15

Study Completion Date

2020-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Head and Neck Carcinoma Adenocarcinoma Recurrent Disease Distantly Metastatic Malignant Neoplasm

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Study Group

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

Group Type EXPERIMENTAL

Anlotinib

Intervention Type DRUG

Anlotinib p.o. qd

Interventions

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Anlotinib

Anlotinib p.o. qd

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No