EUCTR2013-000044-25-FR进行中（未招募）1 期
A Phase I/II randomized study to determine the maximum tolerated dose, safety, pharmacokinetics and antitumor activity of Debio1143 combined with concurrent Chemo-Radiation Therapy in patients with locally advanced squamous cell carcinoma of the head and neck.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 116
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Willing and able to sign a written informed consent;
- •2.Male or female =18 =75 years of age.
- •3.Histologically confirmed diagnosis of previously untreated LA-SCCHN (Stage III, IVa and IVb according to the American Joint Committee on Cancer Staging System) of one or more of the following sites: oral cavity, oropharynx, hypopharynx and larynx;
- •4.Tumour HPV negative status for oropharynx cancer patients, determined by p16 IHC;
- •5.Smokers (> 10 packs/year);
- •6.Availability of pre-treatment tumour sample (optional for Phase I; mandatory for Phase II [10-20 tumour slides]);
- •7.Measurable disease by the RECIST 1.1 criteria;
- •8.Negative medical history of Hepatitis B and Hepatitis C;
- •9.Women of child-bearing potential:
- •a.Negative serum pregnancy test at screening;
- •b.Agreement to use appropriate contraception methods from study entry to 6 months after the last day of treatment. Agreement to use contraception methods from her male partner.
- •10.Male patients agree to use contraception methods from study entry to 6 months after the last day of treatment;
- •11.ECOG performance status 0 or 1
- •12.Subjects must have adequate haematological, renal and hepatic function; calculated creatinine clearance = 60 mL/min as determined by the modified method of Cockcroft and Gault or by the EDTA method, absolute neutrophil count =1 500/µL, platelets =100 000/µL, haemoglobin = 10 g/dL, aspartate (AST) and alanine transaminase (ALT) less than 3 times the upper limit of the normal range (ULN), total bilirubin = 2.0 mg/dL, serum albumin >35 g/L.
- •13.QTcF interval = 450 ms
- •14.Left ventricular ejection fraction (LVEF) within the institutional normal ranges as measured by echocardiogram (ECHO) or multigated acquisition (MUGA) scan;
- •15.No prior treatment with IAP inhibitors.
- •16.No use or requirement for use of aspirin or aspirin containing products with
- •> 100 mg of aspirin per day;
- •17.No history of gastrointestinal bleeding within 1 year;
- •18.No active rheumatoid arthritis, active inflammatory bowel disease, chronic infections, or any other disease or condition associated with chronic inflammation.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 58
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 58
排除标准
- •1.Nasopharyngeal, paranasal sinuses, nasal cavity tumours or thyroid cancers;
- •2.Squamous cell cancer involving cervical neck nodes but from unknown primary site;
- •3.Metastatic disease;
- •4.Any prior or current treatment for invasive head and neck cancer of any kind. This will include but is not limited to: prior tyrosine kinase inhibitors, prior neoadjuvant therapy, prior surgical resection, or use of any investigational agent;
- •5.Weight loss of >10% during the last month;
- •6.Not compensated liver cirrhosis (Child-Pugh class C);
- •7.Gastro-intestinal disorders that could affect drug absorption (including, but not limited to, major abdominal surgery, significant bowel obstruction, ulcerative colitis, Crohn’s disease);
- •8.Impaired bone turnover (serum C-terminal telopeptide [CTX] <300 pg/mL;1
- •9.Concurrent treatment with any other systemic anti-cancer therapy that is not specified as part of the protocol regimen;
- •10.Concomitant treatment with any drug on the prohibited medication list (provided separately);
- •11.Subjects with known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure;
- •12.History of another malignancy within the last 5 years, with the exception of completely resected basal or squamous cell skin cancer, or successfully treated in-situ carcinoma. History of non-invasive lesion or in-situ carcinoma, including in the head and neck region that was successfully treated with surgery, photodynamic or laser, will be permitted;
- •13.Peripheral neuropathy = grade 2;
- •14.Clinical hearing loss (to be confirmed by audiogram in doubtful cases);
- •15.If female, pregnant or lactating;
- •16.History of allergic reactions to appropriate antiemetics (e.g. 5-HT3 antagonists) to be administered with chemotherapy;
- •17.The investigator considers the subject unfit for the study as a result of the medical interview, physical examinations, or screening investigations.
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