- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01875380
Regorafenib in Frail and/or Unfit for Chemotherapy Patients With Metastatic Colorectal Cancer (REFRAME)
31 juillet 2017 mis à jour par: Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
A Phase II Study of Single-agent Regorafenib in the First Line Treatment of Frail and/or Unfit for Polychemotherapy Patients With Metastatic Colorectal Cancer (mCRC)
The purpose of this study is to assess the efficacy and safety of single-agent regorafenib in the first line treatment of frail and/or unfit for polychemotherapy patients with metastatic colorectal cancer (mCRC)
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
46
Phase
- Phase 2
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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-
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Madrid, Espagne, 28046
- Spanish Cooperative Group for Digestive Tumour Therapy (TTD)
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Signing of the informed consent form.
- The patient must be able to understand the information and state expressly his or her desire to take part in the study.
- Age > 18 years.
- Patients with histologically or cytologically documented adenocarcinoma of the colon or rectum who have not been previously treated systemically for advanced disease. Patients can have received fluoropyrimidine-based adjuvant therapy if the last dose was taken at least 6 months prior to study entry.
Patients who are frail and/or unfit for polychemotherapy owing to the presence of one or more of the following criteria:
- Patients with dependence in activities of daily living owing to the presence of comorbidities other than those resulting from the deterioration caused by the neoplastic disease.
Presence in the patient's medical history of three or more of the following comorbidities, even if they are under control with proper treatment:
- Congestive heart failure
- Other chronic cardiovascular diseases
- Chronic obstructive pulmonary disease
- Cerebrovascular disease
- Peripheral neuropathy
- Chronic kidney failure
- Hypertension
- Diabetes mellitus
- Systemic vasculitis
- Severe arthritis
- Presence of geriatric syndromes such as age > 85 years, faecal or urinary incontinence, spontaneous bone fractures, mild and moderate dementia, or patients who fall repeatedly.
- Existence of at least one measurable unidimensional lesion using CT or MRI based on the Response Evaluation Criteria in Solid Tumors criteria (RECIST), version 1.1
- Overall Eastern Cooperative Oncology Group (ECOG) performance less than or equal to 2
- Patient's commitment to compliance with the oral medication throughout the duration of the study
- Life expectancy of at least 3 months
Adequate bone marrow, renal and hepatic function, defined as:
- Neutrophils > 1500/mm3
- Platelets > 100,000/mm3
- Creatinine clearance > 30 ml/min
- Hemoglobin ≥ 9 gr/dl
- Bilirubin levels < 2.5 x ULN
- Aspartate aminotransferase (AST) and alanine transaminase (ALT) levels < 3 x ULN (if liver metastases < 5 x ULN)
Exclusion Criteria:
- Prior treatment with regorafenib.
- Assignment prior to treatment during this study. Patients who are permanently withdrawn from participation in the study treatment will not be allowed to return to it.
- Prior or concurrent presence of another neoplastic disease that is different in terms of tumour site and histology of the colorectal cancer in the 5 years prior to the inclusion of the patient in the study, except in situ cervical cancer, superficial bladder carcinoma [Ta (non-invasive), Tis (carcinoma in situ) and T1 (tumour invades lamina propria)] and non-melanoma skin tumours.
- Presence or history of brain metastases or meningeal tumours.
- Major surgery, open biopsy or traumatic injury within 28 days prior to the start of patient treatment with the study medication.
- Extended-field radiotherapy within 4 weeks prior to randomisation or limited-field radiotherapy in the previous 2 weeks. Patients must have recovered from all treatment-related toxicities.
- Pregnant or breastfeeding women. Women of childbearing age must use adequate contraception. Women of childbearing age must have a negative pregnancy test within 7 days prior to starting with the study medication.
- Women of childbearing age and men who wish to take part in the study must agree to use adequate contraception from the signing of the informed consent until at least 3 months after stopping the study medication. The investigator or the person designated by him or her will ensure and advise as to the contraceptive methods that should be used. Appropriate contraceptive methods include abstinence, oral contraceptives, transdermal patches and injections of sustained-release progestin (starting at least 4 weeks before administration of the IMP), double-barrier method: condom or female condom (diaphragm or cervical/vaginal condom) plus spermicide, intrauterine device (IUD), intrauterine system, implant or vaginal ring (in place at least 4 weeks before administration of the IMP) or male partner sterilization (vasectomy with documentation of azoospermia) prior to inclusion of the woman in the trial if he is the woman's only sexual partner.
- Active congestive heart failure class 2 or higher on the New York Heart Association (NYHA) scale.
- Unstable angina (angina symptoms at rest), new-onset angina (having appeared in the past 3 months) or acute myocardial infarction that has occurred in the 6 months prior to starting with the study medication.
- Cardiac arrhythmias that require anti-arrhythmic therapy (only beta blockers and digoxin would be allowed as concomitant medication for these patients).
- Uncontrolled hypertension (systolic blood pressure > 150 mmHg or diastolic blood pressure > 90 mmHg) despite proper medical management.
- Patients with phaeochromocytoma.
- Pleural effusion or ascites that cause breathing difficulties (dyspnoea of grade ≥2 of the CTC).
- Accidents (including transient ischaemic attacks), deep vein thrombosis or pulmonary thromboembolism that have occurred in the 6 months prior to starting with the study medication.
- Active infection > grade 2 based on the NCI CTC, v. 4.0.
- Human immunodeficiency virus (HIV) infection.
- Active hepatitis B or C, or hepatitis B or C infection that requires treatment with antiviral drugs.
- Patients with severe mental disorders that require medication.
- Presence or history of brain metastases or meningeal tumours.
- History of organ transplants.
- Patients with evidence or history of bleeding diathesis. Any bleeding or bleeding event > Common Toxicity Criteria for Adverse Effects (CTCAE) grade 3 in the 4 weeks prior to starting with the study medication.
- Presence of unhealed wounds, ulcers or bone fractures.
- Kidney failure requiring haemodialysis or peritoneal dialysis.
- Dehydration based on NCI CTC criteria, version 4, of > 1.
- Substance abuse or a history of medical, social or psychological conditions that may interfere with study participation or compliance with the efficacy and safety assessments planned in the study.
- Known hypersensitivity to regorafenib or any of its excipients.
- Presence of any disease or medical condition that might interfere with patient safety or may compromise treatment compliance with it.
- Interstitial lung disease with signs and symptoms present at the time of signing the informed consent.
- Patients who are unable to swallow oral medication.
- Persistent proteinuria > grade 3 based on the NCI CTC, version 4.0 (> 3.5 g/24 hours).
- Intestinal malabsorption syndrome.
- Close personal relationship with the research staff, such as family members of the investigator or dependents (e.g. employees or students of the research centre).
- Unresolved toxicity grade > 1 based on the NCI CTC, version 4.0 (except alopecia), related to any previous therapy or procedure.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: Regorafenib
Regorafenib will be administered orally at the initial dosage of 160 mg per day for 3 weeks,followed by one week of rest, according to the 3/1 regimen.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
---|---|
Progression-free survival rate at 6 months
Délai: 6 months
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6 months
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
---|---|
La survie globale
Délai: 30 mois
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30 mois
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Temps de progression
Délai: 30 mois
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30 mois
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Survie sans progression
Délai: 30 mois
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30 mois
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Durée de réponse
Délai: 30 mois
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30 mois
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Objective response rate
Délai: 30 months
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30 months
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Disease control rate
Délai: 30 months
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30 months
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Time to response
Délai: 30 months
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30 months
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Time to treatment failure
Délai: 30 months
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30 months
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Duration of stable disease
Délai: 30 months
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30 months
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Incidence and severity of Adverse Events (NCI CTC, version 4.0)
Délai: 30 months
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30 months
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Changes in laboratory values (transaminases, bilirubin, lactate dehydrogenase (LDH), anaemia,neutropenia and thrombocytopenia)
Délai: 30 months
|
30 months
|
Change in vital signs (weight loss and hypertension)
Délai: 30 months
|
30 months
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Incidence of dose adjustments and compliance
Délai: 30 months
|
30 months
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Incidence of concomitant medication
Délai: 30 months
|
30 months
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Changes in ECOG performance status over time from baseline
Délai: 30 months
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30 months
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Autres mesures de résultats
Mesure des résultats |
Délai |
---|---|
microRNA expression levels and their correlation with tumour-efficacy parameters (objective response rate, progression-free survival and overall survival), as well as toxicity
Délai: 30 months
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30 months
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Biomarkers associated with cell and tumour growth and/or the mechanism of action of regorafenib and their correlation with patients' clinical progression for efficacy and safety parameters.
Délai: 30 months
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30 months
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Collaborateurs
Les enquêteurs
- Chaise d'étude: Alfredo Carrato, MD-PhD, Ramón y Cajal University Hospital
- Chaise d'étude: Enrique Grande, MD, Ramón y Cajal University Hospital
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Liens utiles
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 juin 2013
Achèvement primaire (Réel)
1 avril 2016
Achèvement de l'étude (Réel)
1 avril 2016
Dates d'inscription aux études
Première soumission
7 juin 2013
Première soumission répondant aux critères de contrôle qualité
10 juin 2013
Première publication (Estimation)
11 juin 2013
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
1 août 2017
Dernière mise à jour soumise répondant aux critères de contrôle qualité
31 juillet 2017
Dernière vérification
1 juillet 2017
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies du système digestif
- Processus pathologiques
- Tumeurs
- Tumeurs par site
- Tumeurs gastro-intestinales
- Tumeurs du système digestif
- Maladies gastro-intestinales
- Maladies du côlon
- Maladies intestinales
- Tumeurs intestinales
- Maladies rectales
- Processus néoplasiques
- Tumeurs colorectales
- Métastase néoplasmique
Autres numéros d'identification d'étude
- TTD-13-01
- 2013-000236-94 (Numéro EudraCT)
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur Tumeurs colorectales
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University of California, San FranciscoComplétéCancer colorectal de stade IV AJCC v8 | Cancer colorectal de stade IVA AJCC v8 | Cancer colorectal de stade IVB AJCC v8 | Cancer colorectal de stade IVC AJCC v8 | Cancer colorectal de stade III AJCC v8 | Cancer colorectal de stade IIIA AJCC v8 | Cancer colorectal de stade IIIB AJCC v8 | Cancer... et d'autres conditionsÉtats-Unis
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City of Hope Medical CenterRecrutementTumeurs colorectales | Cancer colorectal | Troubles colorectaux | Adénocarcinome colorectal | Cancer colorectal stade II | Cancer colorectal stade III | Cancer colorectal stade IV | Polype colorectal | Tumeurs colorectales malignes | Polype adénomateux colorectal | Cancer colorectal stade I | Adénome colorectal... et d'autres conditionsÉtats-Unis, Italie, Chine, Espagne, Japon
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Docbot, Inc.RecrutementAdénome colorectal | Adénocarcinome colorectal | Polype colorectal | ASS colorectalÉtats-Unis
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University of Southern CaliforniaNational Cancer Institute (NCI)RésiliéCancer colorectal de stade IV AJCC v8 | Cancer colorectal de stade IVA AJCC v8 | Cancer colorectal de stade IVB AJCC v8 | Cancer colorectal de stade IVC AJCC v8 | Cancer colorectal de stade III AJCC v8 | Cancer colorectal de stade IIIA AJCC v8 | Cancer colorectal de stade IIIB AJCC v8 | Cancer... et d'autres conditionsÉtats-Unis
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Emory UniversityBristol-Myers Squibb; National Cancer Institute (NCI); National Institutes of...Actif, ne recrute pasCancer colorectal métastatique | Adénocarcinome colorectal | Cancer colorectal de stade IV | Cancer colorectal de stade IVA | Cancer colorectal de stade IVB | Carcinome colorectal réfractaire | Carcinome colorectal stable microsatellite métastatique | Cancer colorectal de stade IVCÉtats-Unis
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Actif, ne recrute pasCancer colorectal de stade IV AJCC v8 | Cancer colorectal de stade IVA AJCC v8 | Cancer colorectal de stade IVB AJCC v8 | Cancer colorectal de stade IVC AJCC v8 | Cancer colorectal de stade III AJCC v8 | Cancer colorectal de stade IIIA AJCC v8 | Cancer colorectal de stade IIIB AJCC v8 | Cancer... et d'autres conditionsÉtats-Unis
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M.D. Anderson Cancer CenterRecrutementAdénocarcinome colorectal | Cancer colorectal de stade IVA AJCC v8 | Cancer colorectal de stade IVB AJCC v8 | Cancer colorectal de stade IVC AJCC v8 | Cancer colorectal de stade III AJCC v8 | Cancer colorectal de stade IIIA AJCC v8 | Cancer colorectal de stade IIIB AJCC v8 | Cancer colorectal de... et d'autres conditionsÉtats-Unis
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Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)RésiliéCancer rectal | Cancer du colon | Survivant du cancer | Adénocarcinome colorectal | Cancer colorectal de stade III AJCC v8 | Cancer colorectal de stade IIIA AJCC v8 | Cancer colorectal de stade IIIB AJCC v8 | Cancer colorectal de stade IIIC AJCC v8 | Cancer colorectal de stade I AJCC v8 | Cancer colorectal... et d'autres conditionsÉtats-Unis
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Sidney Kimmel Cancer Center at Thomas Jefferson...United States Department of DefenseActif, ne recrute pasAdénome colorectal | Cancer colorectal de stade III AJCC v8 | Cancer colorectal de stade IIIA AJCC v8 | Cancer colorectal de stade IIIB AJCC v8 | Cancer colorectal de stade IIIC AJCC v8 | Cancer colorectal de stade 0 AJCC v8 | Cancer colorectal de stade I AJCC v8 | Cancer colorectal de stade II... et d'autres conditionsÉtats-Unis
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Roswell Park Cancer InstituteMerck Sharp & Dohme LLCRetiréAdénocarcinome colorectal métastatique | Adénocarcinome colorectal réfractaire | Microsatellite Stable | Cancer colorectal de stade IV AJCC v8 | Cancer colorectal de stade IVA AJCC v8 | Cancer colorectal de stade IVB AJCC v8 | Cancer colorectal de stade IVC AJCC v8 | Cancer colorectal de stade... et d'autres conditionsÉtats-Unis
Essais cliniques sur Régorafénib
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BayerComplétéNéoplasmeÉtats-Unis
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Erasme University HospitalInconnue
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BayerComplété
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National Taiwan University HospitalNational Taiwan University Hospital, Yun-Lin BranchRecrutementCarcinome hépatocellulaire avancéTaïwan
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BayerComplété
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Instituto do Cancer do Estado de São PauloRecrutementCarcinome hépatocellulaire | Cancer du foieBrésil
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Nanfang Hospital of Southern Medical UniversityJiangsu HengRui Medicine Co., Ltd.RecrutementCarcinome hépatocellulaireChine
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BayerComplétéTumeursL'Autriche, Tchéquie, Suisse, Italie, France, Mexique, Singapour, Luxembourg, Pays-Bas, Espagne, Taïwan, Danemark, Argentine
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Istituto Oncologico Veneto IRCCSComplétéGlioblastome multiformeItalie
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Institut BergoniéBayer; Merck KGaA, Darmstadt, GermanyRecrutementCarcinome hépatocellulaire | Cancer du sein triple négatif | Cancer du poumon non à petites cellules | Sarcome des tissus mous | Carcinome urothélial | Cancer de la thyroïde | Tumeur neuroendocrine gastro-entéropancréatique | Cancer des voies biliaires | Carcinome lié au VPH | Tumeur solide, adulte | Mésothéliomes... et d'autres conditionsFrance