gastroesophageal cancer
Conditions
Interventions
Trade Name: Sertralin ratiopharm 50mg
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: SERTRALINE HYDROCHLORIDE
CAS Number: 79617-96-2
Other descriptive name: SERTRALINE HYDROCHLORIDE
Conc
Sponsors
Med. Univ. Wien, Klinik f. Innere Med I, Onkologie
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Capability of understanding the purpose of the study and have given written informed consent. • Histologically confirmed gastric/gastroesophageal junction/esophageal adenocarcinoma • Measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST version 1.1) • Patients who are planned to first-line palliative immunochemotherapy (FOLFOX/CAPOX + nivolumab) in routine, indication and according to the marketing authorization • Age = 18 years • ECOG-PS 0-2 • Adequate bone-marrow, liver and kidney function • Women of childbearing potential must have a negative pregnancy test at screening, pregnancy testing must be performed within 7 days before first administration of IMP. Approved methods of birth control must be used in women of childbearing potential, including women whose last menstrual period was less than one year prior to screening, unable or unwilling to use adequate contraception from study start to the last dose of protocol therapy. Adequate contraception defined as hormonal birth control, intrauterine device, double barrier method or total abstinence. 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 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: • Use of antidepressants other than sertraline for longer than 6 weeks at time of screening • Use of monoamine oxidase inhibitors (MAOIs), pimozide, phenytoin or linezolid within 28 days of study initiation • Allergy or intolerability to the test drug • Moderate or severe hepatic impairment (Child-Pugh score =7) • QTc in ECG =450ms in adult men and =460ms in adult woman • Sodium levels = 129mmol/L • History of bipolar disorder or mania • History of seizures or convulsions • History of stroke • History of cardiac arrhythmia • Use of any investigational agent within 28 days prior to initiation of study treatment • Pregnant or lactating women • Male subjects unable or unwilling to use adequate contraception methods • Patients with substance abuse disorder or any other medical conditions such as clinically significant neurological or psychological conditions, that may, in the opinion of the investigator, interfere with the subject’s participation in the clinical study or evaluation of the clinical study results
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the ability of sertraline to further improve treatment response in combination with standard first-line immunochemotherapy in patients with metastatic, gastroesophageal, adenocarcinoma.;Secondary Objective: Secondary objectives: To evaluate safety and tolerability of sertraline in combination with standard first-line immunochemotherapy as well as to evaluate QoL and depression of study subjects throughout the treatment. Exploratory objectives: To evaluate biomarkers associated with improved response to the combination of sertraline with standard immunochemotherapy. ;Primary end point(s): The primary endpoint of this study is the rate of best responses per any timepoint during study period after administration of at least one cycle of immunochemotherapy defined as CR and PR according to RECIST 1.1 criteria ;Timepoint(s) of evaluation of this end point: Response to treatment will be assessed every 3rd cycle | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Progression-free survival • Overall survival • Toxicity • Quality of life analyses • Depression scale analyses ;Timepoint(s) of evaluation of this end point: End of Study | — |
Countries
Austria
Outcome results
None listed