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- Registre américain des essais cliniques
- Essai clinique NCT00338026
A Phase I Study of ECO-4601 in Patients With Advanced Cancer
10 juillet 2008 mis à jour par: Thallion Pharmaceuticals
A Phase I, Dose Finding, Pharmacokinetic, and Safety Study of Continuous IV Infusion of ECO-4601 in Patients With Advanced Cancer Including an Extension Portion to Obtain Safety Data at the Highest Tolerable Dose
The purpose of this study was to determine the maximum tolerated dose (MTD) and the recommended dose for future studies of ECO-4601 administered as a continuous IV infusion for 14 days with 7 days recovery (21 day cycle) in patients with histologically confirmed solid tumors (high grade glioma, colorectal, lung, breast, ovarian, pancreatic and prostate).
This study was also designed to determine the clinical pharmacokinetic profile, safety of multiple cycles of administration, and document the antitumor activity of ECO-4601.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
26
Phase
- La phase 1
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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Quebec
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Greenfield Park, Quebec, Canada, J4V 2H1
- Hopital Charles LeMoyne
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Montreal, Quebec, Canada, H3T 1E2
- Sir Mortimer B. Davis Jewish General Hospital
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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:
- Informed about the study and consent to participate in the study
- Clinically or radiologically documented advanced solid malignancy for which no standard therapy is available, or which has failed standard therapy
- Patients with the following solid tumors: high grade glioma, colorectal, prostate, pancreatic, lung, ovarian and breast carcinoma
- Age ≥ 18 years of age
- ECOG ≤ 2
- Laboratory hematology and biochemistry protocol test result abnormalities ≤ Grade 1, graded using NCI CTCAE version 3.0
- Patients with no chemotherapy during the 4 weeks preceding patients' first dose of ECO-4601 (day 1, cycle 1)
- No other anticancer treatment during the study
- Patients can be receiving stable or decreasing dose of steroids within 2 weeks prior to patient's signature of the informed consent
- Patients must be accessible for treatment and follow-up. Patients registered on this trial must be treated and followed at the participating centre
Previous Therapy
- Hormonal therapy: Patients may have had prior hormonal therapy provided it is discontinued upon ICF signature
- Radiation: Patients may have had prior radiation therapy. Patients must have recovered from the acute toxic effects of radiotherapy
- Previous surgery: Previous surgery is permitted provided that at least 2 weeks have elapsed between major surgery (non-biopsy) and ICF signature
Exclusion Criteria:
- Patients with brain metastases
- Unlikely to comply with protocol or difficulty to understand the purpose of the study
- Life expectancy < 12 weeks
- Clinically significant co-morbid disease, e.g. renal failure, ischemic vascular disease, uncontrolled seizure, dementia
- Any patient with a potentially curable malignancy who has not yet received appropriate standard therapies
- Anti seizure drugs known inducers of cytochrome P450
- Documented HIV, active hepatitis B or C infections
- Patients with active or uncontrolled infections or with serious illnesses or medical conditions, which would not permit the patient to be managed according to protocol
- Pregnant or lactating women; both men and women enrolled on study should be using adequate birth control measures throughout the course of the study. Women of childbearing potential must have a negative serum or urine pregnancy test documented within 14 days prior to registration and at study start
- Inability or refusal to practice contraception during therapy of ECO-4601, unless patient is surgically sterile or woman is postmenopausal for at least 2 years
- Patients who have been treated with any investigational drug within 4 weeks of patient's signature of informed consent form, or who are receiving concurrent treatment with other experimental drugs or anti cancer therapy
- Patients in whom a proper central line cannot be established
- Concomitant therapy with therapeutic coumadin; patients can be transferred to low molecular weight heparin
- Patients on low molecular weight heparin for < 2 weeks prior to ICF signature
- Polysorbate 80 being a major constituent of ECO-4601 and known to cause hypotension, patients with uncontrolled hypotension will be excluded
- Known hypersensitivity to farnesylated dibenzodiazepinone or any of the formulation components
Concomitant Therapy Permitted:
- Patients may receive ongoing supportive and palliative care (eg: pain control) as clinically indicated throughout the study.
- Patients can be treated with corticosteroids if medically needed
- Usage of low molecular weight heparin is allowed
- Anti seizure products are permitted provided they are not inducers of cytochrome P450.
Concomitant Therapy Not Permitted:
- Other anticancer treatment
- Other investigational therapy
- Concomitant therapy with coumadin
- Cytochrome enzyme inducing anti epileptics
- G-CSF, GM-CSF and other growth factors may not be used as a substitute for a scheduled dose reduction; however they may be used in the management of acute toxicity such as febrile neutropenia when clinically indicated at the discretion of the investigator. Use of erythropoietin is allowed if treatment has been initiated for ≥ 2 months. Use of growth factors must be documented on case report forms.
- Hormonal therapy
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: Non randomisé
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: ECO-4601
|
Continuous IV infusion for 14 days with 7 days recovery (21 day cycle)
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
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Safety/tolerability of ECO-4601
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Determination of MTD of ECO-4601
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Determination of recommended dose for future studies of ECO-4601
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Mesures de résultats secondaires
Mesure des résultats |
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Pharmacokinetics of ECO-4601
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Safety of multiple cycles of administration of ECO-4601
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Documentation of ECO-4601 antitumor activity as per RECIST criteria
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Petr Kavan, MD, Ph.D., Sir Mortimer B. Davis - Jewish General Hospital
- Chercheur principal: Benoît Samson, MD, Hopital Charles LeMoyne
- Chaise d'étude: Gerald Batist, MD, Sir Mortimer B. Davis - Jewish General Hospital
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 février 2006
Achèvement primaire (Réel)
1 août 2007
Achèvement de l'étude (Réel)
1 août 2007
Dates d'inscription aux études
Première soumission
15 juin 2006
Première soumission répondant aux critères de contrôle qualité
16 juin 2006
Première publication (Estimation)
20 juin 2006
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
15 juillet 2008
Dernière mise à jour soumise répondant aux critères de contrôle qualité
10 juillet 2008
Dernière vérification
1 juillet 2008
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- ECO-4601-101
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 ECO-4601
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Thallion PharmaceuticalsRésiliéGlioblastome multiformeÉtats-Unis, Canada
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Velico MedicalComplété
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University Medicine GreifswaldPas encore de recrutementDouleur aiguëAllemagne
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Instituto de Investigacion Sanitaria La FeCharite University, Berlin, Germany; Imperial College London; Instituto de Investigación... et autres collaborateursRecrutementCancer gynécologique | Fuite anastomotique | Chirurgie cytoréductiveEspagne
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Charles MillerEspiner Medical LTDComplété
-
Centre hospitalier de Ville-Evrard, FranceRecrutementTroubles schizophréniquesFrance
-
Centre hospitalier de Ville-Evrard, FranceRecrutementTrouble bipolaireFrance
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University of California, Los AngelesComplétéMaladies pulmonairesÉtats-Unis
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University of TorontoComplétéMaladies cardiovasculaires | HypercholestérolémieCanada
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University of British ColumbiaThe Lawson FoundationComplété