A Phase 3, Randomized, Open-Label, Two-Arm Study of Neratinib Plus Paclitaxel Versus Trastuzumab Plus Paclitaxel as First-Line Treatment for ErbB-2-Positive Locally Recurrent or Metastatic Breast Cancer - To compare the independently assessed progression-free survival following treatment with neratinib in combination with paclitaxel versus trastuzumab plus paclitaxel in subjects who have not received...

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A Seamless, Phase 1/2, Multiple Ascending Dose, Proof of Concept Study of ATN-103 Administered to Subjects With Active Rheumatoid Arthritis on a Background of Methotrexate To evaluate the safety and clinical efficacy of multiple ascending doses (MAD) of ATN-103 administered SC to subjects with active RA compared with placebo.

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A Phase I/II Safety and Exploratory Pharmacodynamic Study of Intravenous Temsirolimus (CCI-779) in Pediatric Subjects with Relapsed/Refractory Solid Tumors Part 1 (Part 1 is now closed): Primary Objective - To evaluate the safety of IV temsirolimus given once weekly to children with solid tumors with disease that is recurrent or refractory to standard th...

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Combination therapy with rheumatoid arthritis (COBRA)-light study, an open randomised trial comparing a modified COBRA therapy with the COBRA therapy according to treatment strategies for rheumatoid arthritis (BeSt) in early rheumatoid arthritis Not provided at time of registration

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A Double-Blind, Placebo-Controlled, Parallel, Randomized Study To Evaluate The Efficacy And Safety Of 3 Oral Dose Levels Of TMI-005 In Subjects With Active Rheumatoid Arthritis On A Background Of Methotrexate To compare the efficacy and the safety of 3 dose levels of oral TMI-005 in comparison with placebo in subjects with active RA who have been receiving stable doses of MTX.

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A Double-Blind, Placebo-Controlled, Randomized, Single-Dose, 2-Period Crossover Study of the Pharmacodynamics of Orally Administered PSI-697 in Healthy Subjects Who Smoke To assess the pharmacodynamics (PD) of a single oral dose of PSI-697 in healthy subjects who smoke.

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Reformulated BeneFIX efficacy and safety after conversion from a pdFIX To collect data around the period of the conversion from pdFIX to BeneFIX in patients for whom a conversion to BeneFIX has already been decided by the investigator. The main following parameters will ...

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A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, LONG-TERM EXTENSION STUDY TO DETERMINE THE SAFETY, TOLERABILITY, AND PRELIMINARY LONG TERM EFFICACY OF LECOZOTAN SRA-333 SR IN PATIENTS WITH MILD TO MODERATE ALZHEIMER S DISEASE TREATED WITH A CHOLINESTERASE INHIBITOR To evaluate the safety and tolerability of long-term therapy with three total daily dose levels of lecozotan SR 2, 5, 10 mg administered to patients with mild to moderate Alzheimer s Disease who hav...

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A 3 Month, Randomised, Open Label, Parallel Group, Descriptive Study to Explore and Compare Perceptions and Satisfaction for Two Different Delivery Mechanisms for Etanercept (Etanercept Autoinjector and the Etanercept Prefilled Syringe) in Patients with Psoriasis To compare patient satisfaction with two different delivery devices for etanercept after 12 weeks of use, using a 10 point scale form totally dissatisfied to totally satisfied.

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A Phase 1/2 Study of SKI-606 in Philadelphia Chromosme Positive Leukemias Part 1 (Dose-escalation part): Part 1 of study is Completed - Define the maximum tolerated dose, less than or equal to 1000 mg/day, in subjects with CML in chronic phase resistant or refractory to ima...

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