A research study to investigate the safety of setanaxib and helpfulness in the treatment of recurrent or metastatic squamous cell carcinoma of thehead and neck (SCCHN)
- Conditions
- Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-509917-35-00
- Lead Sponsor
- Calliditas Therapeutics Suisse S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 48
1. Male or female patients aged =18 years, inclusive, at the time of informed consent., 10. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1., 11. Adequate organ and bone marrow function within 35 days of starting study treatment. Criteria a” to c” cannot be met in patients with ongoing or recent (within 14 days of screening test) transfusions or who require ongoing growth factor support: a. Absolute neutrophil count =1,000/mm3 (=1.0×109/L). (For France: 1.500/mm3 [=1.5×109/L]). b. Platelet count =100,000/mm3 (=100×109/L). c. Haemoglobin =9 g/dL, in the absence of transfusions for at least 2 weeks. Patients requiring ongoing transfusions or growth factor support to maintain haemoglobin =9g/dL are not eligible. d. Total bilirubin =1.5×upper limit of normal (ULN) (if associated with liver metastases or Gilbert's disease, =3×ULN). e. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =3×ULN. f. Serum creatinine =2.0 mg/dL or creatinine clearance =40 mL/min (measured or calculated according to the method of Cockcroft and Gault). (For France: Serum creatinine =2.0 mg/dL and creatinine clearance =40 mL/min [measured or calculated according to the method of Cockcroft and Gault])., 12. Female patients of childbearing potential must use a highly effective method of contraception to prevent pregnancy for =4 weeks before randomisation and must agree to continue strict contraception up to 120 days after the last dose of IMP or pembrolizumab, whichever is the later. a. For the purposes of this study, women of childbearing potential are defined as fertile, following menarche and until becoming postmenopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy.” b. Postmenopausal state is defined as no menses for 12 months without an alternative medical cause. In female patients who are not using hormonal contraception or hormonal replacement therapy but with suspected menopause and less than 12 months of amenorrhea, a high follicle stimulating hormone (FSH) level in the postmenopausal range will be required at Screening to confirm a postmenopausal state. Confirmation with more than one FSH measurement is required. c. Highly effective contraception is defined as methods that can achieve a failure rate of less than 1% per year when used consistently and correctly. These methods are: i. Combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, or transdermal) ii. Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, or implantable) iii. Intrauterine device iv. Intrauterine hormone-releasing system v. Bilateral tubal occlusion vi. Vasectomised partner vii. Sexual abstinence (refraining from heterosexual intercourse during the entire period of risk associated with the study treatments). The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the patient. Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhoea method are not acceptable methods of contraception)., 13. Female patients of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Baseline/Randomisation before dosi
1. Diagnosis of immunosuppression or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment, with the exception of intranasal and inhaled corticosteroids or systemic corticosteroids at doses not to exceed 10 mg/day of prednisone or equivalent. Steroids as premedication for hypersensitivity reactions due to radiographic contrast agents are allowed. (For France: Patients with prior solid organ transplant or bone marrow transplant will be excluded)., 10. Active autoimmune disease requiring systemic treatment within the past 3 months or documented history of clinically severe autoimmune disease, or syndrome that requires systemic steroids or immunosuppressive agents. The following are exceptions to this criterion: a. Patients with vitiligo or alopecia. b. Any chronic skin condition that does not require systemic therapy. c. Patients with coeliac disease controlled by diet alone., 11. Any evidence of current interstitial lung disease or pneumonitis, or a prior history of interstitial lung disease or non-infectious pneumonitis requiring high-dose glucocorticoids., 12. Active infection requiring systemic therapy., 13. Known human immunodeficiency virus (HIV) infection or acute or chronic hepatitis B or C infection. Patients with a past or resolved hepatitis B virus infection (defined as the presence of hepatitis B core antibody [HBcAb] and absence of hepatitis B surface antigen [HBsAg]) are eligible provided the hepatitis virus DNA test is negative. Patients positive for hepatitis C antibody are eligible only if polymerase chain reaction (PCR) is negative for hepatitis C virus RNA. Patients with ongoing anti-viral therapy with potent inhibitors of cytochrome P450 (CYP) 3A4 are not eligible. Testing for HIV is only required if clinically indicated and is not mandatory for this study., 14. Serious chronic gastrointestinal conditions associated with diarrhoea., 15. History of significant haematological problems, such as blood dyscrasias requiring treatment, aplastic anaemia, myelodysplastic syndrome, or leukaemia., 16. Surgery (eg, stomach bypass) or medical condition that might significantly affect absorption of medicines (as judged by the investigator)., 17. A positive pregnancy test or breastfeeding for female patients., 18. Evidence of any of the following cardiac conduction abnormalities: a QTc Fredericia interval >450 milliseconds for male patients or >470 milliseconds for female patients. Patients with a second- or third-degree atrioventricular block are to be excluded., 19. TSH >ULN at Screening., 2. Anti-cancer monoclonal antibody treatment within 4 weeks prior to study Day 1., 20. Unstable cardiovascular disease as defined by any of the following: a. Unstable angina within 6 months prior to Screening. b. Myocardial infarction, coronary artery bypass graft surgery, or coronary angioplasty within 6 months prior to Screening. c. Cerebrovascular accident within 6 months prior to Screening. d. New York Heart Association Class III or IV heart failure., 21. Presence of any laboratory abnormality or condition that, in the opinion of the investigator, could interfere with or compromise a patient’s treatment, assessment, or compliance with the protocol and/or study procedures., 22. Any other condition that, in the opinion of the investigator, constitutes a risk or contraindication for the participation of the patient in the study, or that could interfere with the
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method