Vinorelbine Inhibits Oncogenic Functions of MKK3: a New Therapeutic Opportunity for Patients with Metastatic Colorectal Cancer

Overview

Sponsor-declared trial summary

Key facts

Sponsor

I.F.O. Istituti Fisioterapici Ospitalieri

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Decision date (initial)

2025-05-09

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

Primary Objective. Objective Response Rate (ORR) according to RECIST 1.1 criteria

Secondary objectives 1

1. 1. Progression Free Survival (PFS) 2. Overall survival (OS) 3. Safety/Toxicity rate 4. Quality of Life (QoL)

Conditions and MedDRA coding

METASTATIC COLORECTAL CANCER

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. histologically proven diagnosis of CRC; - measurable metastatic disease according to RECIST 1.1; - availability of histological specimens; - no evidence of brain or meningeal disease. Treated and clinically stable brain metastases are permitted; - age ≥ 18 years; - ECOG performance status = 0-2; - life expectancy > 3 months; - patients must have received all standard treatments indicated for metastatic disease (chemotherapy and/or targeted or immunological therapy) and have relapsed or progressed compared to a previous therapy. - if female of childbearing age, have a negative pregnancy test performed no more than 7 days before the start of study treatment; - If female of childbearing potential or male, agree to use adequate contraception (e.g., abstinence, intrauterine device, oral contraceptive, or double barrier method) based on investigators judgment; Childbearing patients must use two methods of contraception; - Adequate bone marrow, liver, and kidney function assessed within 14 days prior to the start of study treatment; - Patients able to understand the Italian language and to adhere to the study by signing, personally or by means of a designated witness, the informed consent (to trial and to data processing) prior to any study-specific procedures; - Patients must be fit for treatment and follow-up. - Investigators must ensure that enrolled patients in this trial will be available to provide complete documentation of treatment, toxicity, response assessment, and FU.

Exclusion criteria 1

1. Patients with a history of other malignancies, except adequately treated non-melanoma skin cancer, curatively treated in situ cervical cancer, prostate cancer with stable PSA for ≥ 3 years, or other curatively treated solid tumors with no evidence of disease for ≥ 5 years; - Pregnant or breastfeeding women. - Patients receiving concomitant treatment with other anticancer therapies; - Patients with active or uncontrolled infections, or serious illnesses or medical conditions that would not allow that patient to be managed according to the protocol; - Patients with untreated and/or uncontrolled cardiovascular conditions and/or symptomatic cardiac dysfunction (unstable angina, congestive heart failure, myocardial infarction in the previous year or cardiac ventricular arrhythmias requiring medication, history of 2nd or 3rd degree atrioventricular conduction defects) are not eligible; - Other concomitant investigational drugs. - Known intolerance to the study drug or any of the excipients. - Any pre-existing or current medical or other condition that in the opinion of the investigator(s) would preclude the participant from participating in this study

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. ORR is defined as the percentage of patients, relative to the total of enrolled subjects, achieving a complete (CR) or partial (PR) response, according to RECIST 1.1 criteria. The determination of clinical response will be based on investigator-reported measurements. Responses will be evaluated with a chest and abdominal computed tomography (CT) scan every 8 weeks. Patients who do not have an on-study assessment will be included in the analysis as non-responders.

Secondary endpoints 1

1. Progression-free survival (PFS).Overall survival (OS).Toxicity rate.Quality of Life (QoL) is

Investigational products

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

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

I.F.O. Istituti Fisioterapici Ospitalieri

Sponsor organisation

I.F.O. Istituti Fisioterapici Ospitalieri

Address

Via Elio Chianesi N 53

City

Rome

Postcode

00144

Country

Italy

Scientific contact point

Organisation

I.F.O. Istituti Fisioterapici Ospitalieri

Contact name

Gianluca Bossi

Public contact point

Organisation

I.F.O. Istituti Fisioterapici Ospitalieri

Contact name

Gianluca Bossi

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

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

Documents 9 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