Selective serotonin reuptake inhibition in patients with advanced gastroesophageal cancer receiving immunochemotherapy: a prospective phase II trial

Phase 1

• Conditions: gastroesophageal cancer; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2022-001989-36-AT
• Lead Sponsor: Med. Univ. Wien, Klinik f. Innere Med I, Onkologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-08-12
• Last Update Posted: 21 August 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 35

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

•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified