- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02092922
A Phase 2 Trial of Filanesib in Relapsed/Refractory Multiple Myeloma (AfFIRM)
The AfFIRM Study is a Phase 2 study during which patients with advanced multiple myeloma will receive single-agent investigational study drug filanesib (ARRY-520). Patients will be followed to determine the effectiveness of filanesib in treating myeloma. Approximately 160 patients from North America and Europe will be enrolled in this study.
Eligible patients will have received at least two prior lines of therapy; have received prior bortezomib and lenalidomide; and have disease refractory to carfilzomib and/or pomalidomide.
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Réel)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
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Dresden, Allemagne
- TU Dresden Medizinische Fakultat, Medizinische Klinik und Poliklinik I
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Hamburg, Allemagne
- Asklepios Kliniken Hamburg GmbH
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Heidelberg, Allemagne
- University Hospital Heidelberg
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Leipzig, Allemagne
- University Hospital Leipzig
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Tubingen, Allemagne
- University of Tubingen
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Wurzburg, Allemagne
- Julius Maximilians Universitat Wurzburg
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Bruxelles, Belgique
- Institut Jules Bordet
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Leuven, Belgique
- Universitaire Ziekenhuizen Leuven
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Alberta
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Calgary, Alberta, Canada
- Tom Baker Cancer Centre
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Nova Scotia
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Halifax, Nova Scotia, Canada
- QEII Health Sciences Center
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Quebec
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Montreal, Quebec, Canada
- Jewish General Hospital
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Badalona, Espagne
- Hospital Germans Trias i Pujol
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Barcelona, Espagne
- Hospital Clínic de Barcelona
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Valencia, Espagne
- Hospital Clínico Universitario de Valencia
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Valencia, Espagne
- Hospital Universitario La Fe
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Zaragoza, Espagne
- Hospital Quiron de Zaragoza
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Bierre-Benite Cedex, France
- Centre hospitalier Lyon-Sud
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Lille Cedex, France
- Hopital Claude Huriez
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Marseille Cedex 9, France
- Institut Paoli Calmettes
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Nantes Cedex, France
- Chu Hotel Dieu
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Nimes Cedex 9, France
- G.H.U Caremeau
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Toulouse, France
- Institut Universitaire de Cancer
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Tours Cedex, France
- CHU tours-Hopital Bretonneau
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Vandoeuvre les Nancy, France
- CHU de Nancy - Hopital de Brabois
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Athens, Grèce
- General Hospital of Athens "Evangelismos"
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Athens, Grèce
- University of Athens School of Medicine
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London, Royaume-Uni
- Kings College Hospital NHS Foundation Trust
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London, Royaume-Uni
- Barts Health NHS Trust
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Southhampton, Royaume-Uni
- Southhampton General Hospital
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Surrey, Royaume-Uni
- The Royal Marsden NHS Foundation Trust
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Wolverhampton, Royaume-Uni
- New Cross Hospital
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Alabama
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Birmingham, Alabama, États-Unis, 35249
- UAB Comprehensive Cancer Center
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California
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Duarte, California, États-Unis, 91010
- City of Hope
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San Francisco, California, États-Unis, 94143
- University of California, San Francisco Medical Center
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Colorado
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Aurora, Colorado, États-Unis, 80045
- University of Colorado
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Denver, Colorado, États-Unis, 80218
- Colorado Blood Cancer Institute
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Connecticut
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New Haven, Connecticut, États-Unis, 06510
- Yale Comprehensive Cancer Center
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Georgia
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Atlanta, Georgia, États-Unis, 30322
- Emory University, Winship Cancer Institute
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Illinois
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Chicago, Illinois, États-Unis, 60611
- Northwestern University
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Chicago, Illinois, États-Unis, 60612
- Rush University Medical Center
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Decatur, Illinois, États-Unis, 62526
- Decatur Memorial Hospital
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Kansas
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Westwood, Kansas, États-Unis, 66205
- University of Kansas Cancer Center and Medical Pavilion
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Kentucky
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Lexington, Kentucky, États-Unis, 40536
- University of Kentucky
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Louisville, Kentucky, États-Unis, 40202
- Norton Cancer Institute
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Maryland
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Bethesda, Maryland, États-Unis, 20817
- Center for Cancer and Blood Disorders
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Massachusetts
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Boston, Massachusetts, États-Unis, 02111
- Tufts Medical Center
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Michigan
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Detroit, Michigan, États-Unis, 48201
- Karmanos Cancer Institute
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Missouri
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Saint Louis, Missouri, États-Unis, 63130
- Washington University in St. Louis
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Nebraska
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Lincoln, Nebraska, États-Unis, 68506
- Nebraska Hematology Oncology, P.C.
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Nevada
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Las Vegas, Nevada, États-Unis, 89169
- Comprehensive Cancer Centers of Nevada
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New York
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New York, New York, États-Unis, 10029
- Mount Sinai Medical Center
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New York, New York, États-Unis, 10065
- NY Presbyterian - Weill Cornell Medical Center
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North Carolina
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Charlotte, North Carolina, États-Unis, 28204
- Levine Cancer Institute
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Durham, North Carolina, États-Unis, 27710
- Duke Cancer Center
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Ohio
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Cleveland, Ohio, États-Unis, 44195
- Cleveland Clinic
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South Carolina
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Charleston, South Carolina, États-Unis, 29425
- Medical University of South Carolina
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Texas
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Dallas, Texas, États-Unis, 75390
- UT Southwestern Medical Center
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Houston, Texas, États-Unis, 77030
- MD Anderson Cancer Center
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Utah
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Salt Lake City, Utah, États-Unis, 84112
- Huntsman Cancer Institute
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Washington
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Spokane Valley, Washington, États-Unis, 99216
- Cancer Care Northwest
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Key Inclusion Criteria:
Patients with confirmed multiple myeloma whose treatment history must include all of the following:
- Received at least 2 prior lines of therapy (induction therapy and stem cell transplant ± maintenance are to be considered a single line of therapy).
- Received at least 2 cycles of a bortezomib-containing regimen and 2 cycles of a lenalidomide-containing regimen, unless intolerant to these agents (defined as requiring discontinuation due to toxicity).
- Disease refractory to a carfilzomib-containing regimen and/or a pomalidomide containing regimen. Refractory is defined as either failure to achieve a minimal response (MR) or better while on therapy, or development of progressive disease (PD) while on therapy or within 60 days from last dose of therapy.
Measurable multiple myeloma disease, defined as meeting at least one of the following criteria within 14 days prior to first dose of study drug:
- A monoclonal Ig (M-protein) concentration on serum protein electrophoresis (SPEP) of ≥ 1.0 g/dL.
- Measurable urinary light chain secretion by quantitative analysis using urine protein electrophoresis (UPEP) of ≥ 200 mg/24 hours.
- Involved serum free light chain (FLC) level ≥ 10 mg/dL, provided the serum FLC ratio is abnormal.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 within 14 days prior to first dose of study drug.
- Adequate hematology, hepatic and renal function laboratory values within 14 days prior to first dose of study drug.
- Additional criteria exist.
Key Exclusion Criteria:
- Prior treatment with filanesib (ARRY-520) or any other KSP inhibitor.
- Past or current plasma cell leukemia.
- Primary amyloidosis (amyloidosis associated with multiple myeloma is allowed).
- POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes).
- Autologous or allogeneic stem cell or bone marrow transplant within 3 months prior to first dose of study drug.
- Concomitant malignancies or previous malignancies (other than multiple myeloma) with less than a 2-year disease-free interval at the time of first dose of study drug. Patients with adequately resected basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix or breast, or Stage 1 prostate cancer are eligible irrespective of the time of diagnosis.
- Use of an investigational agent that is not expected to be cleared by the time of first dose of study drug or that has been demonstrated to have prolonged side effects. Patients must have recovered from all side effects to a Grade 0 or 1 (except alopecia and neuropathy).
- Any severe concurrent disease or condition (including severe graft-versus-host disease, requirement for dialysis, symptomatic congestive heart failure [New York Heart Association Class III or IV], unstable angina pectoris, cardiac arrhythmia) which, in the judgment of the Investigator, would make the patient inappropriate for study participation.
- Known positive serology for the human immunodeficiency virus (HIV), active hepatitis B and/or hepatitis C.
- Acute active infection requiring treatment.
- Additional criteria exist.
Plan d'étude
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 |
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Expérimental: Filanesib
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norme de soins
multiple dose, single schedule
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
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In patients with low Baseline alpha 1-acid glycoprotein (AAG), assess the efficacy of the study drug in terms of objective response rate.
Délai: up to 2 years
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up to 2 years
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
---|---|
In patients with high Baseline AAG, assess the efficacy of the study drug in terms of objective response rate.
Délai: up to 2 years
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up to 2 years
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In all patients, assess the efficacy of the study drug in terms of duration of response.
Délai: up to 2 years
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up to 2 years
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In all patients, assess the efficacy of the study drug in terms of progression-free survival.
Délai: up to 2 years
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up to 2 years
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In all patients, assess the efficacy of study drug in terms of overall survival.
Délai: up to 2 years
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up to 2 years
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In all patients, assess the safety of the study drug in terms of adverse events, clinical laboratory tests and electrocardiograms.
Délai: up to 2 years
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up to 2 years
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In a subset of all patients, characterize the pharmacokinetics (PK) of the study drug in terms of plasma concentration-time profiles.
Délai: 6 months
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6 months
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In a subset of all patients, assess the correlation between study drug exposure and changes in corrected QT interval (QTc) in terms of changes in QTc versus time-matched study drug plasma concentrations.
Délai: 6 months
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6 months
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies cardiovasculaires
- Maladies vasculaires
- Maladies du système immunitaire
- Tumeurs par type histologique
- Tumeurs
- Troubles lymphoprolifératifs
- Troubles immunoprolifératifs
- Maladies hématologiques
- Troubles hémorragiques
- Troubles hémostatiques
- Paraprotéinémies
- Troubles des protéines sanguines
- Myélome multiple
- Tumeurs, plasmocyte
- Effets physiologiques des médicaments
- Mécanismes moléculaires de l'action pharmacologique
- Agents antinéoplasiques
- Facteurs immunologiques
- Agents antimitotiques
- Modulateurs de mitose
- Adjuvants, immunologique
- Lénograstim
- Filanésib
Autres numéros d'identification d'étude
- ARRAY-520-215
- 2014-001051-23 (Numéro EudraCT)
- C4371002 (Autre identifiant: Pfizer)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
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 .
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