- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00718523
Study of Adding AMG 479 to First Line Chemotherapy in Patients With Optimally Debulked Epithelial Ovarian Cancer
A Randomized, Double-blind, Placebo Controlled, Multi-center, Phase II Study of Adding AMG 479, a Fully Human Monoclonal Antibody Against Insulin-like Growth Factor Type 1 Receptor (IGF-1R) to First Line Chemotherapy in Patients With Optimally Debulked ( < 1 cm ) Epithelial Ovarian Cancer
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
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Berlin, Allemagne, 12200
- Charite Campus Benjamin Franklin
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Berlin, Allemagne, 13353
- University Hospital Charité
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Bonn, Allemagne, 53105
- Universitat Bonn
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Erlangen, Allemagne, 91054
- Universitätsklinikum Erlangen
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Hamburg, Allemagne, 20246
- Universitatsklinikum Hamburg Eppendorf
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Homburg, Allemagne, 66421
- Universitatsklinikum des Saarlandes
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Kassel, Allemagne, 34125
- Klinikum Kassel
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Munich, Allemagne, 80637
- Rotkreuzkrankenhaus Munchen
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Tubingen, Allemagne, 72076
- Universitats Frauenklinik Tubingen
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Alberta
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Edmonton, Alberta, Canada, T6G1Z2
- Cross Cancer Institute
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Ontario
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London, Ontario, Canada, N6A4L6
- London Health Science Center
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Quebec
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Montreal, Quebec, Canada, H3T1E2
- Jewish General Hospital
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Montreal, Quebec, Canada, H2L4M1
- CHUM Hopital Notre Dame
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Barcelona, Espagne, 08036
- Hospital Clinic I Provincial
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Guadalajara, Espagne, 19002
- Hospital Universitario de Guadalajara
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La Laguna, Espagne, 38320
- Hospital Universitario de Tenerife
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Madrid, Espagne, 28041
- Hospital U 12 de Octubre
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Sevilla, Espagne, 341071
- Hospital Universitario Virgen Macarena de Sevilla
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La Roche Sur Yon, France, 85925
- Centre Hospitalier Départemental Les Oudairies
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Lyon, France, 69373
- Centre Leon Bérard
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Neuilly Sur Seine, France, 92200
- Clinique Hartmann
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Paris, France, 75005
- Institut Curie
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Dublin, Irlande
- St Jame's Hospital
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Waterford, Irlande
- Waterford Regional Hospital
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Kfar-Saba, Israël, 44281
- Meir Medical Center
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Ramat Gan, Israël, 52621
- Sheba Medical Center
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Rehovot, Israël, 76100
- Kaplan Medical Center
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Tel Aviv, Israël, 64239
- Sourasky Medical Center
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Zrifin, Israël, 70300
- Asaf Harofe MC
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Leeds, Royaume-Uni, LS97TF
- Saint James's University Hospital
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London, Royaume-Uni, W1T4TJ
- University College London
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Northwood, Royaume-Uni, HA62RN
- Mount Vernon Cancer Centre
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California
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Alhambra, California, États-Unis, 91801
- Central Hematology Oncology Medical Group Inc.
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Burbank, California, États-Unis, 91505
- Providence Saint Joseph Medical Center
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Fullerton, California, États-Unis, 92835
- St Jude Heritage Healthcare
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La Verne, California, États-Unis, 91750
- Wilshire Oncology Medical Group Inc
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Los Angeles, California, États-Unis, 90033
- University of Southern California
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Los Angeles, California, États-Unis, 90048
- Cedars-Sinai Medical Center
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Los Angeles, California, États-Unis, 90095-1678
- UCLA
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Northridge, California, États-Unis, 91325
- North Valley Hematology/Oncology Medical Group
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Oxnard, California, États-Unis, 93030
- Ventura County Hematology-Oncology Specialists
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San Francisco, California, États-Unis, 94115
- University of California San Francisco
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santa Maria, California, États-Unis, 93454
- Central Coast Medical Oncology Corporation
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Connecticut
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New Haven, Connecticut, États-Unis, 06510
- Yale University School Of Medicine
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Florida
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Hollywood, Florida, États-Unis, 33021
- Memorial Cancer Institute
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Orlando, Florida, États-Unis, 32804
- Florida Hospital Cancer Institute
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Tampa, Florida, États-Unis, 33612
- Moffitt Cancer Center
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Georgia
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Atlanta, Georgia, États-Unis, 30322
- Winship Cancer Institute Emory University School of Medicine
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Louisiana
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Metairie, Louisiana, États-Unis, 70006
- Hematology And Oncology Specialists, Llc
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Minnesota
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Rochester, Minnesota, États-Unis, 55905
- Mayo Clinic
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Nevada
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Henderson, Nevada, États-Unis, 89052
- Comprehensive Cancer Centers of Nevada
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North Carolina
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Asheville, North Carolina, États-Unis, 28806
- Hope A Women's Cancer Center
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Winston-Salem, North Carolina, États-Unis, 27104
- Wake Forest University Baptist Medical Center
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Ohio
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Toledo, Ohio, États-Unis, 43614
- University of Toledo
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Toledo, Ohio, États-Unis, 43606
- The Toledo Hospital
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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
Inclusion Criteria:
- Histologically-confirmed optimally debulked (< 1 cm) FIGO stage III or stage IV (positive pleural cytology only) ovarian epithelial (including fallopian tube and primary peritoneal) carcinoma.
- Patients should have undergone surgical debulking, by a surgeon experienced in the management of ovarian cancer, with the aim of maximal surgical cytoreduction. All patients must be optimally debulked as defined as having no residual tumor of greater than 1 cm in the post surgical setting.
- Patients with stage IV disease will be eligible if a positive pleural cytology is the only extra peritoneal disease.
- Paraffin block (or 10 - 20 unstained slides) and fresh frozen surgical/biopsy specimens of the primary tumor are required at baseline.
- No prior systemic treatment in the primary disease treatment setting.
- Female ≥ 18 years of age or legal age.
- ECOG performance status ≤ 2.
- Adequate organ and bone marrow function
Non diabetic patients or Type 1 or 2 Diabetic Patients:
• Diabetes must be controlled with HgbA1c < 8% and fasting blood glucose level <160 mg/dL.
- Patient must be willing and able to comply with scheduled visits, and all study procedures.
- Informed consent obtained.
- Patients should be able to commence systemic therapy within 6 weeks of cytoreductive surgery.
- Life expectancy > 12 weeks.
- Adequate coagulation parameters (within 14 days prior to randomization), International Normalized Ratio (INR) ≤1.5; Activated Prothrombin Time (APTT) ≤ 1.5 x ULN
Exclusion Criteria:
- Non-epithelial ovarian cancer, including malignant mixed Mullerian tumors.
- Borderline tumors (tumors of low malignant potential).
- Planned intraperitoneal cytotoxic chemotherapy.
- Prior systemic anticancer therapy for ovarian cancer.
- Any previous radiotherapy to the abdomen or pelvis.
- Patients with synchronous primary endometrial carcinoma, or a past history of primary endometrial carcinoma, are excluded unless ALL of the following criteria for describing the endometrial carcinoma are met: Stage ≤ Ib, no more than superficial myometrial invasion, no lymphovascular invasion, not poorly differentiated (i.e., not Grade 3 or papillary serous or clear cell).
- Diagnosis of any second malignancy within the last 5 years, except for adequately treated basal cell or squamous cell skin cancer, or in situ carcinoma of the cervix uteri or curatively treated DCIS/LCIS, or non-melanoma or in situ melanoma skin cancer.
- Prior treatment with a humanized monoclonal antibody anticancer therapeutic.
- Prior treatment with investigational treatment targeted to IGF axis including, but not limited to, CP 751,871, IM-A12, RO4858696.
- Previous exposure to AMG 479.
- Anticipation of a need for a major surgical procedure or radiation therapy during the study.
- History of hypersensitivity to recombinant proteins.
- Treatment with radiotherapy, surgery, or an investigational agent within 4 weeks of randomization.
- Any of the following within 6 months prior to study enrollment: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, NYHA class III or IV congestive heart failure, cerebrovascular accident or transient ischemic attack, grade > 2 peripheral neuropathy, pulmonary embolism, deep vein thrombosis, or other thromboembolic event.
- History of brain metastases, spinal cord compression, or carcinomatous meningitis.
- Patient of child-bearing potential is pregnant (eg, positive human chorionic gonadotropin test) or is breast feeding.
- Patient of child-bearing potential is not willing to use adequate contraceptive precautions.
- Known active infection, or on antiretroviral therapy for HIV disease.
- Known positive test for chronic hepatitis B or C infection.
- Any other underlying physical or mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study.
- Refusal or inability to give informed consent to participate in the study.
- Other severe acute or chronic medical or psychiatric condition, or significant laboratory abnormality requiring further investigation that may cause undue risk for the patient's safety, inhibit protocol participation, or interfere with interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Comparateur placebo: A
Placebo plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of placebo administered on Day 1 of each 21-day cycle.
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Matching placebo administered Day 1 of each 21 day cycle.
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Expérimental: B
AMG 479 plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of AMG 479 single agent administered on Day 1 of each 21-day cycle.
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Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Progression Free Survival (PFS): Time From Randomization Until Date of Progression or Death.
Délai: Radiological tumor assessment: every 12(+/- 1) weeks for 3 years after randomization + CA 125: day 1 of each cycle
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A patient may have been declared to have progressive disease on the basis of radiological measuremt of tumor lesions assessmt or CA125 evaluation (tumor measuremts taking precedence).Radiological progression was defined as per the RECIST guidelines (Therasse et al, JNCI2000) as at least 20% increase in the sum of the longest diameters of target lesions(ref the smallest sum of the longest diam recorded since the treatmt started or since the appearance of at least 1 new lesion).Serum CA125 progression was defined, according to the 2005 GCIG def: pts with:
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Radiological tumor assessment: every 12(+/- 1) weeks for 3 years after randomization + CA 125: day 1 of each cycle
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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Time To Progression (TTP): Interval From the Date of Randomization to the Date of Disease Progression
Délai: Radiological tumor assessment: every 12 (+/- 1) weeks for 3 years after randomization + CA125: day 1 of each cycle
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A patient may have been declared to have progressive disease on the basis of radiological measuremt of tumor lesions assessmt or CA125 evaluation (tumor measuremts taking precedence).Radiological progression was defined as per the RECIST guidelines (Therasse et al, JNCI2000) as at least 20% increase in the sum of the longest diameters of target lesions(ref the smallest sum of the longest diam recorded since the treatmt started or since the appearance of at least 1 new lesion).Serum CA125 progression was defined, according to the 2005 GCIG def: pts with:
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Radiological tumor assessment: every 12 (+/- 1) weeks for 3 years after randomization + CA125: day 1 of each cycle
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Overall Survival (OS)
Délai: Day 1 of each cycle up to 4 years after randomization
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Interval between the date from randomization to death from any cause whichever came first.
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Day 1 of each cycle up to 4 years after randomization
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
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 (Estimation)
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
- Tumeurs par type histologique
- Tumeurs
- Tumeurs urogénitales
- Tumeurs par site
- Carcinome
- Tumeurs, glandulaires et épithéliales
- Tumeurs génitales, femme
- Maladies du système endocrinien
- Maladies ovariennes
- Maladies annexielles
- Troubles gonadiques
- Tumeurs des glandes endocrines
- Tumeurs ovariennes
- Carcinome épithélial ovarien
- Effets physiologiques des médicaments
- Facteurs immunologiques
- Anticorps monoclonaux
Autres numéros d'identification d'étude
- TRIO 014
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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