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

NCT03591666 | Unknown Phase 2 DMC

• 1 other identifier: 2018HNRT02
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Carcinoma; Adenocarcinoma; Recurrent Disease; Distantly Metastatic Malignant Neoplasm

Keywords

head and neck adenocarcinoma; Anlotinib

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  up to 24 months

Secondary Outcomes (3)

• Progress free survival (PFS)

  up to 24 months

• Disease Control Rate (DCR)

  up to 24 months

• Overall Survival (OS)

  up to 24 months

Study Arms (1)

Study Group

EXPERIMENTAL

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

Drug: Anlotinib

Interventions

Anlotinib DRUG

Anlotinib p.o. qd

Study Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed head and neck adenocarcinoma.
• Patients with recurrent or metastatic head and neck adenocarcinoma who are not candidates for curative surgery or radiotherapy.
• Measurable disease per the RECIST criteria.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
• Provision of written informed consent.
• 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.

You may not qualify if:

• Prior treatment with Anlotinib
• With pleural effusion or ascites, cause respiratory syndrome
• Accepted the vascular endothelial growth inhibitor class targeted drug treatment of patients
• 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
• 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

Sponsors & Collaborators

• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University: lead

Study Sites (1)

Shanghai ninth people's hospital

Shanghai, Shanghai Municipality, 200011, China

Location

MeSH Terms

Conditions

Adenocarcinoma; Recurrence

Interventions

anlotinib

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Guopei Zhu

  Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shengjin Dou

CONTACT

+8615800386875; doushengjin@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2018
• First Posted: July 19, 2018
• Study Start: July 15, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2020
• Last Updated: July 19, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)