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Apatinib for Advanced Non-squamous Head and Neck Cancer

Primary Purpose

Head and Neck Neoplasms

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Apatinib
Sponsored by
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Neoplasms focused on measuring apatinib, advanced head and neck cancer, non-squamous

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 years to 75 years;
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2;
  • Life expectancy of more than 12 weeks;
  • At least one measurable lesion according to RECIST 1.1 which has not received radiotherapy =< 3 months;
  • Histologically confirmed advanced (unresectable, locally advanced, recurrent or metastatic) non-squamous head and neck cancer, including adenocarcinoma, mucoepidermoid carcinoma, acinar cell carcinoma and adenoid cystic carcinoma;
  • Recurrent and or metastatic lesions which are not suitable for local treatment;
  • For patients with mucoepidermoid carcinoma, acinar cell carcinoma or adenoid cystic carcinoma, metastatic disease documented as having shown progression on a scan (CT, MRI) compared to a previous scan taken at any time in the past 12 months;
  • For patients with adenocarcinoma, one regimen of prior chemotherapy was received for recurrent and or metastatic diseases;
  • Adequate hepatic, renal, heart, and hematologic functions: absolute neutrophil count (ANC) ≥ 1.5×109/L, platelet count (PLT) ≥ 100×109/L, hemoglobin (HB) ≥ 90 g/L, total bilirubin (TBIL) ≤ 1.5×upper limit of normal (ULN), alternate aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 2.5×ULN (or ≤ 5×ULN in patients with liver metastases), Serum Cr ≤ 1×ULN, Cr clearance ≥ 50 mL/min, international normalized ratio (INR) < 1.5 or PT < ULN+4s or activated partial thromboplastin time (APTT) < 1.5×ULN, proteinuria < (++) or urinary protein ≤ 1.0 g/24 hrs;
  • For women of child-bearing age, the pregnancy test results (serum or urine) within 7 days before enrolment must be negative. They will take appropriate methods for contraception during the study until the 8th week post the last administration of study drug. For men (previous surgical sterilization accepted), will take appropriate methods for contraception during the study until the 8th week post the last administration of study drug.
  • Signed informed consent.

Exclusion Criteria:

  • Accumulation of coelomic fluid (e.g. pleural effusion, ascites fluid, cardiac effusion) requiring treatment;
  • Other malignancy within the past five years other than basal cell skin cancer, or carcinoma in situ of the cervix;
  • Factors affecting the oral medication (e.g. inability to swallow, chronic diarrhea and intestinal obstruction);
  • Major injuries and/or surgery =< 4 weeks prior to registration with incomplete wound healing. Patients who have received radiotherapy (except local palliative radiotherapy), chemotherapy, molecular targeted therapy =< 3 weeks, or nitrosoureas/mitomycin chemotherapy =< 6 weeks prior to registration;
  • Patients with poor-controlled arterial hypertension (systolic pressure ≥ 140 mmHg and/or diastolic pressure ≥ 90 mm Hg) despite standard medical management;
  • Suffered from grade II or above myocardial ischemia or myocardial infarction, uncontrolled arrhythmias (including QT interval male ≥ 450 ms, female ≥ 470 ms). Grade III-IV cardiac insufficiency according to New York Heart Association (NYHA) criteria or echocardiography check: left ventricular ejection fraction (LVEF)<50%;
  • History of clinically significant haemoptysis =< 2 months (more than half of one tea spoon of fresh blood per day) prior to registration. Coagulation disfunction, hemorrhagic tendency or receiving anticoagulant therapy;
  • History of clinically relevant major bleeding event (e.g. gastrointestinal hemorrhage, bleeding ulcer, occult blood ≥ (++), and vasculitis) =< 3 months prior to randomization;
  • Patients who have active brain metastases or leptomeningeal disease. Patients with treated brain metastases are eligible if they are clinically stable with regard to neurologic function, off steroids after cranial irradiation ending at least 3 weeks prior to randomization, or after surgical resection performed at least 3 weeks prior to randomization. No evidence of Grade greater than or equal to 1 central nervous system (CNS) hemorrhage based on pretreatment CT or MRI scan;
  • Centrally located tumors of local invasion of major blood vessels, or distinct interstitial lung disease by the chest radiographic findings (CT or MRI);
  • Treatment with other investigational drugs or other anti-cancer therapy;
  • Previous therapy with other VEGFR inhibitors (other than bevacizumab);
  • Treatment in another investigational trial =< 4 weeks prior to registration;
  • History of hypersensitivity to apatinib and/or the excipients of the trial drugs;
  • Active or chronic hepatitis C and/or B infection, or other active uncontrolled infection;
  • History of immunodeficiency disease (including HIV positive), concurrent acquired or congenital immunodeficiency syndrome, or history of organ transplantation;
  • History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess =< 6 months prior to registration;
  • History of arterial or venous thromboembolic events (e.g. cerebrovascular accident, cardiovascular accident, deep venous thrombosis and pulmonary embolism) =< 12 months prior to randomization;
  • Administration of strong/potent cytochrome P450 (CYP)3A4 inhibitors within 7 days, or inducers within 12 days;
  • Evidence of significant medical illness that in the investigator's judgment will substantially increase the risk associated with the subject's participation in and completion of the study;
  • History of mental diseases;
  • Other conditions regimented at investigators' discretion.

Sites / Locations

  • Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) & Peking Union Medical College (PUMC)Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

apatinib

Arm Description

apatinib 500mg p.o. qd

Outcomes

Primary Outcome Measures

Response Rate

Secondary Outcome Measures

Progression-free survival

Full Information

First Posted
December 8, 2016
Last Updated
December 11, 2016
Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02989259
Brief Title
Apatinib for Advanced Non-squamous Head and Neck Cancer
Official Title
The Clinical Study of Apatinib for Patients With Advanced Non-squamous Head and Neck Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2016 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
In this study, the investigators try to evaluate the efficacy and safety of apatinib in advanced non-squamous head and neck cancer and to validate the correlative biomarkers.
Detailed Description
There is no standard therapy for patients with advanced (unresectable, locally advanced, recurrent or metastatic) non-squamous head and neck cancer. Apatinib is a novel vascular endothelial growth factor receptor 2 tyrosine kinase inhibitor, which has been approved for the treatment of patients with advanced gastric cancer refractory to two or more lines of prior chemotherapy. Vascular endothelial growth factor is highly expressed in non-squamous head and neck cancer and its expression correlates with stage, tumour size, vascular invasion, recurrence and metastasis. In this study, the investigators try to evaluate the efficacy and safety of apatinib in advanced non-squamous head and neck cancer and to validate the correlative biomarkers.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Neoplasms
Keywords
apatinib, advanced head and neck cancer, non-squamous

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
apatinib
Arm Type
Experimental
Arm Description
apatinib 500mg p.o. qd
Intervention Type
Drug
Intervention Name(s)
Apatinib
Other Intervention Name(s)
ApatinibMesylate tablet
Intervention Description
apatinib 500mg p.o. qd
Primary Outcome Measure Information:
Title
Response Rate
Time Frame
up to 3 years
Secondary Outcome Measure Information:
Title
Progression-free survival
Time Frame
up to 3 years
Other Pre-specified Outcome Measures:
Title
Overall survival
Time Frame
up to 3 years
Title
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame
up to 3 years
Title
serum soluble VEGFR2
Time Frame
baseline
Title
tumor phosphorylated VEGFR2 (p-VEGFR2) expressions
Time Frame
baseline

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: 18 years to 75 years; Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2; Life expectancy of more than 12 weeks; At least one measurable lesion according to RECIST 1.1 which has not received radiotherapy =< 3 months; Histologically confirmed advanced (unresectable, locally advanced, recurrent or metastatic) non-squamous head and neck cancer, including adenocarcinoma, mucoepidermoid carcinoma, acinar cell carcinoma and adenoid cystic carcinoma; Recurrent and or metastatic lesions which are not suitable for local treatment; For patients with mucoepidermoid carcinoma, acinar cell carcinoma or adenoid cystic carcinoma, metastatic disease documented as having shown progression on a scan (CT, MRI) compared to a previous scan taken at any time in the past 12 months; For patients with adenocarcinoma, one regimen of prior chemotherapy was received for recurrent and or metastatic diseases; Adequate hepatic, renal, heart, and hematologic functions: absolute neutrophil count (ANC) ≥ 1.5×109/L, platelet count (PLT) ≥ 100×109/L, hemoglobin (HB) ≥ 90 g/L, total bilirubin (TBIL) ≤ 1.5×upper limit of normal (ULN), alternate aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 2.5×ULN (or ≤ 5×ULN in patients with liver metastases), Serum Cr ≤ 1×ULN, Cr clearance ≥ 50 mL/min, international normalized ratio (INR) < 1.5 or PT < ULN+4s or activated partial thromboplastin time (APTT) < 1.5×ULN, proteinuria < (++) or urinary protein ≤ 1.0 g/24 hrs; For women of child-bearing age, the pregnancy test results (serum or urine) within 7 days before enrolment must be negative. They will take appropriate methods for contraception during the study until the 8th week post the last administration of study drug. For men (previous surgical sterilization accepted), will take appropriate methods for contraception during the study until the 8th week post the last administration of study drug. Signed informed consent. Exclusion Criteria: Accumulation of coelomic fluid (e.g. pleural effusion, ascites fluid, cardiac effusion) requiring treatment; Other malignancy within the past five years other than basal cell skin cancer, or carcinoma in situ of the cervix; Factors affecting the oral medication (e.g. inability to swallow, chronic diarrhea and intestinal obstruction); Major injuries and/or surgery =< 4 weeks prior to registration with incomplete wound healing. Patients who have received radiotherapy (except local palliative radiotherapy), chemotherapy, molecular targeted therapy =< 3 weeks, or nitrosoureas/mitomycin chemotherapy =< 6 weeks prior to registration; Patients with poor-controlled arterial hypertension (systolic pressure ≥ 140 mmHg and/or diastolic pressure ≥ 90 mm Hg) despite standard medical management; Suffered from grade II or above myocardial ischemia or myocardial infarction, uncontrolled arrhythmias (including QT interval male ≥ 450 ms, female ≥ 470 ms). Grade III-IV cardiac insufficiency according to New York Heart Association (NYHA) criteria or echocardiography check: left ventricular ejection fraction (LVEF)<50%; History of clinically significant haemoptysis =< 2 months (more than half of one tea spoon of fresh blood per day) prior to registration. Coagulation disfunction, hemorrhagic tendency or receiving anticoagulant therapy; History of clinically relevant major bleeding event (e.g. gastrointestinal hemorrhage, bleeding ulcer, occult blood ≥ (++), and vasculitis) =< 3 months prior to randomization; Patients who have active brain metastases or leptomeningeal disease. Patients with treated brain metastases are eligible if they are clinically stable with regard to neurologic function, off steroids after cranial irradiation ending at least 3 weeks prior to randomization, or after surgical resection performed at least 3 weeks prior to randomization. No evidence of Grade greater than or equal to 1 central nervous system (CNS) hemorrhage based on pretreatment CT or MRI scan; Centrally located tumors of local invasion of major blood vessels, or distinct interstitial lung disease by the chest radiographic findings (CT or MRI); Treatment with other investigational drugs or other anti-cancer therapy; Previous therapy with other VEGFR inhibitors (other than bevacizumab); Treatment in another investigational trial =< 4 weeks prior to registration; History of hypersensitivity to apatinib and/or the excipients of the trial drugs; Active or chronic hepatitis C and/or B infection, or other active uncontrolled infection; History of immunodeficiency disease (including HIV positive), concurrent acquired or congenital immunodeficiency syndrome, or history of organ transplantation; History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess =< 6 months prior to registration; History of arterial or venous thromboembolic events (e.g. cerebrovascular accident, cardiovascular accident, deep venous thrombosis and pulmonary embolism) =< 12 months prior to randomization; Administration of strong/potent cytochrome P450 (CYP)3A4 inhibitors within 7 days, or inducers within 12 days; Evidence of significant medical illness that in the investigator's judgment will substantially increase the risk associated with the subject's participation in and completion of the study; History of mental diseases; Other conditions regimented at investigators' discretion.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaohui He, B.D.
Phone
+86-13810670129
Email
xiaohuih2008@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lin Gui, M.D.
Phone
+86-13520372817
Email
guilindoctor@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaohui He, B.D.
Organizational Affiliation
Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) & Peking Union Medical College (PUMC)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) & Peking Union Medical College (PUMC)
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaohui He, B.D.
Phone
+86-13810670129
Email
xiaohuih2008@163.com
First Name & Middle Initial & Last Name & Degree
Lin Gui, M.D.
Phone
+86-13520372817
Email
guilindoctor@126.com
First Name & Middle Initial & Last Name & Degree
Xiaohui He, B.D.
First Name & Middle Initial & Last Name & Degree
Lin Gui, M.D.

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26884585
Citation
Li J, Qin S, Xu J, Xiong J, Wu C, Bai Y, Liu W, Tong J, Liu Y, Xu R, Wang Z, Wang Q, Ouyang X, Yang Y, Ba Y, Liang J, Lin X, Luo D, Zheng R, Wang X, Sun G, Wang L, Zheng L, Guo H, Wu J, Xu N, Yang J, Zhang H, Cheng Y, Wang N, Chen L, Fan Z, Sun P, Yu H. Randomized, Double-Blind, Placebo-Controlled Phase III Trial of Apatinib in Patients With Chemotherapy-Refractory Advanced or Metastatic Adenocarcinoma of the Stomach or Gastroesophageal Junction. J Clin Oncol. 2016 May 1;34(13):1448-54. doi: 10.1200/JCO.2015.63.5995. Epub 2016 Feb 16.
Results Reference
result
PubMed Identifier
21183517
Citation
Le Tourneau C, Razak AR, Levy C, Calugaru V, Galatoire O, Dendale R, Desjardins L, Gan HK. Role of chemotherapy and molecularly targeted agents in the treatment of adenoid cystic carcinoma of the lacrimal gland. Br J Ophthalmol. 2011 Nov;95(11):1483-9. doi: 10.1136/bjo.2010.192351. Epub 2010 Dec 22.
Results Reference
result

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Apatinib for Advanced Non-squamous Head and Neck Cancer

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