A Study of Apatinib Plus Tegafur Gimeracil Oteracil in Recurrent/Metastatic Head and Neck Cancers

NCT03096184 | Unknown Phase 2 DMC

• 1 other identifier: 2017HNRT001
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

This is a non-randomized, phase II, open label study of apatinib mesylate tablets plus tegafur gimeracil oteracil potassium capsules in recurrent/metastatic squamous cell carcinoma of head and neck. The primary purpose of this study is to evaluate the efficacy of apatinib mesylate tablets plus tegafur gimeracil oteracil potassium capsules in recurrent/metastatic squamous cell carcinoma of head and neck

Conditions

Head and Neck Squamous Cell Carcinoma

Keywords

head and neck cancer; Apatinib; Tegafur Gimeracil Oteracil

Outcome Measures

Primary Outcomes (2)

• Progression-free survival(PFS)

  from date of enrollment until date of first documented disease progression or death from any cause, assessed up to 2 years

  2 years

• Overall survival

  from date of enrollment until date of first death from any cause, assessed up to 2 years

  2 years

Secondary Outcomes (1)

• Acute toxicity profiles, graded according to the NCI CTCAE version 3.0

  6 months

Study Arms (1)

Study Group

EXPERIMENTAL

Apatinib Mesylate Tablets and Tegafur Gimeracil Oteracil Potassium Capsules administered as a daily oral treatment

Drug: Apatinib Mesylate Tablets; Drug: Tegafur Gimeracil Oteracil Potassium Capsules

Interventions

Apatinib Mesylate Tablets DRUG

500 mg qd.p.o. every day for 21 days as a cycle

Also known as: Aitan

Study Group

Tegafur Gimeracil Oteracil Potassium Capsules DRUG

50mg bid p.o. every day for 14 days as a cycle

Also known as: Aiyi

Study Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically / cytologically confirmed diagnosis of recurrent or metastatic squamous cell carcinoma of head and neck origin not amenable to curative intent therapy; both human papillomavirus (HPV)(+) and HPV(-) tumors are eligible; tumors (squamous histology) of unknown primary that are clearly related to the head and neck area are eligible
• Presence of measurable lesions (RECIST V1.1)
• Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
• Absolute neutrophil count (ANC) \>= 1.5 x 10\^9/L
• Platelets \>= 100 x 10\^9/L
• Hemoglobin (Hb) \> 9 g/dL
• Total calcium (corrected for serum albumin) within normal limits
• Magnesium \>= the lower limit of normal for the institution
• Potassium within normal limits for the institution
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) within 1.5 x normal range (or =\< 3.0 x upper limit of normal \[ULN\] if liver metastases are present)
• Serum bilirubin within normal range (or =\< 1.5 x ULN if liver metastases are present; or total bilirubin =\< 3.0 x ULN with direct bilirubin within normal range in patients with well documented Gilbert syndrome)
• Serum creatinine =\< 1.5 x ULN or 24-hour clearance \>= 50 mL/min
• Serum amylase =\< ULN
• Serum lipase =\< ULN
• Fasting plasma glucose =\< 120 mg/dL (6.7 mmol/L)

You may not qualify if:

• 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%;
• Patients who have had prior allergic reaction to Apatinib;
• The subject has had another active malignancy within the past five years except for cervical cancer in site, in situ carcinoma of the bladder or non-melanoma carcinoma of the skin;
• Clinically significant and uncontrolled major medical conditions including but not limited to: active uncontrolled infection, symptomatic congestive heart failure, Unstable angina pectoris or cardiac arrhythmia, psychiatric illness/ social situation that would limit compliance with study requirements; any medical condition, which in the opinion of the study investigator places the subject at an unacceptably high risk for toxicities;
• Patients undergoing therapy with other investigational agents.
• Women who are pregnant or breastfeeding;
• Patients with any other concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for participation in the study.

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

Squamous Cell Carcinoma of Head and Neck; Head and Neck Neoplasms

Interventions

apatinib

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: March 25, 2017
• First Posted: March 30, 2017
• Study Start: December 23, 2016
• Primary Completion: July 31, 2018
• Study Completion: May 1, 2019
• Last Updated: October 9, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)