Etude : SOREGATT / PRODIGE 68 - UCGI 38



ATTENTION : pour chaque essai clinique, les éléments affichés ci-dessous ne sont pas exhaustifs, et le protocole fourni par le promoteur reste l’unique document à consulter pour mener à bien un essai clinique sur centre. Pour plus d'informations, contactez le référent du territoire concerné.


Acronyme / Nom
Situation thérapeutique
Traitement
Cadre réglementaire
MÀJ
Présentation de l'étude
Acronyme / Nom : SOREGATT / PRODIGE 68 - UCGI 38

Situation thérapeutique : Métastatique ou localement avancé

Traitement : Chimiothérapie / Thérapie ciblée

Cadre réglementaire : RIPH2

Dernière MÀJ : 29/09/2021
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : Essai de phase II randomisé comparant les séquences de regorafenib et trifuridine/tipiracil, après échec des thérapies standards chez des patients atteints d’un cancer colorectal métastatique

Spécialité : Organes digestifs
Localisation : C18 - Tumeur maligne du côlon

Spécialité : Organes digestifs
Localisation : C20 - Tumeur maligne du rectum
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : Multicenter, international, comparative, randomized, open-label, phase II study conducted in two parallel groups.

The study population will consist of male and female patients aged ≥18 years old with metastatic colorectal cancer after failure of fluoropyrimidine-, irinotecan-, and oxaliplatin-based chemotherapies, as well as epidermal growth factor receptor (EGFR) and vascular endothelial growth factor (VEGF) inhibitors in patients eligible for these treatments.

Patients will be randomized according to a 1:1 ratio to treatment arms A and B.

Arm A: regorafenib until disease progression or unacceptable toxicity occurs, followed by trifluridine/tipiracil until disease progression or unacceptable toxicity occurs.
Arm B: trifluridine/tipiracil until disease progression or unacceptable toxicity occurs, followed by regorafenib until disease progression or unacceptable toxicity occurs.

Phase : II

Stade : Métastatique

2, 3, 4, X
Informations libres de droit
Critères d'inclusion
Critères de non-inclusion
Informations libres de droit
Critères d'inclusion et de non-inclusion
Critères d'inclusion : - Patients must have provided informed consent before performing any study specific procedures.
- Histological or cytological documented adenocarcinoma of the colon or rectum.
- Patients with metastatic colorectal cancer (stage IV).
- Measurable disease, defined as at least one unidimensional measurable lesion on a computed tomography (CT) scan according to RECIST v1.1.
- The patient must have received two or more previous lines of treatment for metastatic disease. The prior treatment lines must include at least one fluoropyrimidine-based chemotherapy combined with oxaliplatin and/or irinotecan (including FOLFOX, FOLFIRI or FOLFOXIRI) as well as EGFR and/or VEGF inhibitors in patients eligible for these treatments.
- Patients considered eligible for treatment with both regorafenib and trifluridine-tipiracil.
- Male or female patients aged ≥18 years.
- ECOG performance status of ≤1.
- Adequate bone marrow, liver and renal functions as assessed by the following laboratory requirements:
* Total bilirubin ≤1.5 x upper limit of normal (ULN).
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 x ULN (≤5 x ULN for patients with liver metastasis).
* Alkaline phosphatase limit ≤2.5 x ULN (≤5 x ULN for patients with liver metastasis).
* Serum creatinine ≤1.5 x ULN.
* International normalized ratio (INR) and partial thromboplastin time (PTT) ≤1.5 x ULN. Patients receiving anticoagulants, such as warfarin or heparin are eligible if there is no prior evidence of an underlying abnormality with coagulation.
* Platelet count ≥100000 /mm³, hemoglobin (Hb) ≥9 g/dL, absolute neutrophil count (ANC) ≥1500/mm³. Blood transfusions to meet this inclusion criterion are not allowed.
- Women of childbearing potential and men must agree to use a highly effective contraception (1% failure rate) from the signing of the informed consent form until at least 6 months after the last study drug administration. Women using hormonal contraceptive must also use a barrier method.
- Women of childbearing potential must have a negative pregnancy test within 7 days before starting study treatment.
- Patients affiliated to the social security system.
- Patient willing and able to comply with the protocol for the duration of the study including treatment, scheduled visits, and examinations throughout the study, including follow up.

Critères de non-inclusion : - Patients with symptomatic brain or meningeal metastasis, unless definitive therapy occurred more than 6 months ago and with a confirmation of tumoral control within 4 weeks of starting study treatment.
- Previous or concurrent cancer that is distinct in primary site or histology from colorectal cancer within 5 years prior to study inclusion, except for curatively treated in situ cervical cancer, non-melanoma skin cancer, and superficial bladder tumors: staged Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor with lamina propria invasion).
- Prior treatment with regorafenib or any other tyrosine kinase inhibitor.
- Prior treatment with trifluridine/tipiracil.
- Known hypersensitivity to any of the study drugs, study drug classes, or study drug excipients.
- Unresolved toxicity grade >1 (by CTCAE v5.0) caused by prior therapy/procedure, excluding alopecia, hypothyroidism, and oxaliplatin-induced neurotoxicity grade ≤2.
- Patient with severe hepatic impairment (Child-Pugh C).
- Known UGT1A1 and/or UGT1A9 polymorphisms. History of Gilbert's syndrome.
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before starting study treatment.
- Chemotherapy within 21 days of starting study treatment.
- Radiotherapy within 4 weeks of starting study treatment, except for palliative radiotherapy within 2 weeks.
- Active cardiac disease including any of the Following:
* Congestive heart Failure: New York Heart Association (NYHA) class ≥2.
* Unstable angina (angina symptoms at rest), or a new-onset angina (within the 3 months before enrolment).
* Myocardial infarction that occurred less than 6 months before enrolment.
* Cardiac arrhythmias requiring anti-arrhythmic therapy (treatment with beta blockers or digoxin are permitted)
* Uncontrolled hypertension (systolic blood pressure >140 mmHg or diastolic pressure >90 mmHg despite treatment).
- Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism within 6 months of starting study treatment.
- Ongoing infection grade 2 (CTCAE v5.0).
- Known history of human immunodeficiency virus (HIV) infection.
- Active hepatitis B or C, or chronic hepatitis B or C requiring treatment with antiviral therapy.
- Patients with seizure disorder requiring medication.
- Patients with a history of any bleeding diathesis, irrespective of the severity.
- Any hemorrhage or bleeding event grade ≥3 (CTCAE v5.0) within 4 weeks before starting study treatment.
- Presence of a wound, ulcer, or bone fracture that is not healing.
- Patients unable to swallow oral medications.
- Bowel malabsorption or extended bowel resection that could affect the absorption of regorafenib, occlusive syndrome.
- Presence of gastro-intestinal fistula or perforation.
- Any illness or medical conditions that are unstable or could jeopardize the safety of the patient and their compliance in the study.
- Patients participating in another therapeutic study within the 30 days before enrolment.
- Pregnant or breast feeding women.
- Person deprived of their liberty or under protective custody or guardianship.
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
NCT04450836
Promoteur :
Unicancer
Type de sponsor : Institutionnel
3, avenue du Général Harris
14000 CAEN

Coordonnateur :
Centre investigateur
Investigateur
TEC / ARC / IDE
État
MÀJ
Informations relatives aux investigateurs
Centre investigateur :
CHU de Rouen - 1 Rue de Germont - 76000 ROUEN

Investigateur :
non connu

TEC / ARC / IDE :
Patricia FOSSE
patricia.fosse@
chu-rouen.fr

Statut de l'essai : OUVERT

MAJ : 29/09/2021