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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Medical University Of Vienna

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

25 Apr 2023 → ongoing

Decision date (initial)

2024-12-11

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2024-518631-11-00

EudraCT number

2022-001989-36

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Therapy

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 objectives 1

1. 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.

Conditions and MedDRA coding

gastroesophageal cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. • 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 XML File Identifier: 51bQzQYkow8BoTwrtT9YKUHXaRs= Page 10/20 of protocol therapy. Adequate contraception defined as hormonal birth control, intrauterine device, double barrier method or total abstinence.

Exclusion criteria 1

1. 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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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

Secondary endpoints 1

1. • Progression-free survival • Overall survival • Toxicity • Quality of life analyses • Depression scale analyses

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Medical University Of Vienna

Sponsor organisation

Medical University Of Vienna

Address

Spitalgasse 23, Alsergrund Alsergrund

City

Vienna

Postcode

1090

Country

Austria

Scientific contact point

Organisation

Medical University Of Vienna

Contact name

Department of Medicine I ,Division of Oncology

Public contact point

Organisation

Medical University Of Vienna

Contact name

Department of Medicine I ,Division of Oncology

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 5 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications