A Study of Anlotinib in Recurrent/Metastatic Head and Neck Adenocarcinomas
Primary Purpose
Head and Neck Carcinoma, Adenocarcinoma, Recurrent Disease
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Anlotinib
Sponsored by
About this trial
This is an interventional treatment trial for Head and Neck Carcinoma focused on measuring head and neck adenocarcinoma, Anlotinib
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
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
Sites / Locations
- Shanghai ninth people's hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Study Group
Arm Description
Anlotinib QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
Outcomes
Primary Outcome Measures
Objective Response Rate (ORR)
Secondary Outcome Measures
Progress free survival (PFS)
Disease Control Rate (DCR)
Overall Survival (OS)
Full Information
NCT ID
NCT03591666
First Posted
July 9, 2018
Last Updated
July 9, 2018
Sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
1. Study Identification
Unique Protocol Identification Number
NCT03591666
Brief Title
A Study of Anlotinib in Recurrent/Metastatic Head and Neck Adenocarcinomas
Official Title
A Non-randomized Phase II Study of Anlotinib in Recurrent/Metastatic Head and Neck Adenocarcinomas
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 15, 2018 (Anticipated)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Carcinoma, Adenocarcinoma, Recurrent Disease, Distantly Metastatic Malignant Neoplasm
Keywords
head and neck adenocarcinoma, Anlotinib
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
51 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Study Group
Arm Type
Experimental
Arm Description
Anlotinib QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
Intervention Type
Drug
Intervention Name(s)
Anlotinib
Intervention Description
Anlotinib p.o. qd
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Time Frame
up to 24 months
Secondary Outcome Measure Information:
Title
Progress free survival (PFS)
Time Frame
up to 24 months
Title
Disease Control Rate (DCR)
Time Frame
up to 24 months
Title
Overall Survival (OS)
Time Frame
up to 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shengjin Dou
Phone
+8615800386875
Email
doushengjin@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guopei Zhu
Organizational Affiliation
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai ninth people's hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200011
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study of Anlotinib in Recurrent/Metastatic Head and Neck Adenocarcinomas
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