Estudio de fase II del anticuerpo trifuncional anti-HER-2/neu x anti-CD3 ertumaxomab en pacientes con cáncer de mama avanzado o metastásico resistente al tratamiento hormonal que expresa HER­2/neu 1+ o 2 Phase II study of the trifunctional anti-HER-2/neu x anti-CD3 antibody ertumaxomab for hormone therapy refractory patients with HER-2/neu 1+ or 2+ expressing advanced or metastatic breast cancer To demonstrate clinical efficacy of the investigational trifunctional antibody (ertumaxomab) for the treatment of hormone therapy refractory advanced or metastatic breast cancer tumors (stage IIIb or ...

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Determination of systemic exposure and characterization of pharmacokinetics of the tri-functional antibody catumaxomab (anti-EpCAM X anti-CD3) administered intraperitoneally in EpCAM positive cancer patients with malignant ascites - Determination of systemic exposure of catumaxomab during and after four intraperitoneal infusions with increasing doses - Characterization of pharmacokinetics of catumaxomab after the second, the th...

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Prospective, randomized, multi-center, open label phase III study to evaluate the efficacy and safety of immunosuppression following a heart-beating cadaveric renal transplantation based on the use of rabbit anti-T-lymphocyte serum, tacrolimus and mycophenolate, free of concomitant corticosteroids from the start of immunosuppression The primary objective of the study is the assessment of the overall graft rejection rate (acute, chronic and subclinical) between a treatment with ATG-Fresenius administered in addition to standard tr...

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Two-arm, randomized (2:1), open-label phase II/III study in EpCAM positive cancer patients with symptomatic malignant ascites using paracentesis plus the tri-functional antibody removab (anti-EpCAM x anti-CD3) versus paracentesis alone To demonstrate the superiority of a treatment with paracentesis plus removab over a treatment with paracentesis alone in terms of puncture free survival

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Phase II study for repeated dosing of the trifunctional bispecific anti-HER-2/neu x anti-CD3 antibody ertumaxomab in patients with HER-2/neu 1+ or 2+/FISH negative expressing advanced or metastatic breast cancer (stage IIIb/IV) progressing after endocrine treatment The primary objective of the study is to demonstrate clinical efficacy of the investigational trifunctional bispecific antibody ertumaxomab for treatment of patients with HER-2/neu 1+ or 2+ expressing...

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Phase I/II dose-escalation study of the investigational trifunctional bispecific anti-CD20 x anti-CD3 antibody FBTA05 in relapsed or refractory chronic lymphocytic leukemia Phase I, Dose escalation • determination of the maximum tolerated dose (MTD) of FBTA05 in patients with relapsed or refractory chronic lymphocytic leukemia (B-CLL). Phase II, Efficacy • evaluation of ...

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Treatment of Graves’ Orbitopathy (GO) with ATG-Fresenius: A prospective, randomized, open, controlled phase II study to assess the efficacy and safety of an add-on ATG-Fresenius treatment versus a standard steroid treatment The primary objective of the study is to investigate whether add-on treatment of ATG-Fresenius S to standard steroid therapy has a beneficial effect on response to therapy defined as Clinical Activity...

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Fresenius IV-ERT-BC-03 : Essai de phase 2 évaluant l’efficacité et la tolérance d’un traitement par ertumaxomab chez des patientes ayant un cancer du sein. [Informations issues du site clinicaltrials.gov et traduites par l'INCa] [essai clos aux inclusions] Phase II study for repeated dosing of the trifunctional bispecific anti-HER-2/neu x anti-CD3 antibody ertumaxomab in patients with HER-2/neu 1+ or 2+/FISH negative expressing advanced or metastatic br...

• Country France
• organs Sein
• Specialty Thérapies Ciblées

GvHD prophylaxis with ATG-Fresenius S in allogenic Stem Cell Transplantation from matched unrelated donors: A randomised phase III multicenter trial comparing a standard GvHD prophylaxies with cyclosporine A and Methotrexate with additional pretransplant ATG-Fresenius S Valutare l'efficacia di ATG-Fresenius S in aggiunta alla terapia standard (ciclosporina A/Metotressato) nel trattamento del fallimento precoce della terapia definito come il verificarsi della malattia...

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Multicenter, open-label and randomized phase II study to evaluate safety and efficacy of the tri-functional bispecific antibody catumaxomab(anti-EpCAM x anti-CD3) in patients after curative resection of a confirmed gastric adenocarcinoma compared with surgery alone Investigation of the outcome of an adjuvant treatment with catumaxomab as compared to surgery alone in patients after curative resection of a gastric adenocarcinoma in order to gain more detailed info...

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