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First-in-man Dose Escalation Study of BAY2010112 in Patients With Prostate Cancer

Bayer · 2012
ClinicalTrials.gov · Datasets · License: Public Domain · 2012
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antibodiesprostate-cancerprostatic-neoplasms
This is the first study where BAY2010112 is given to humans. Patients with castration resistant prostate cancer will be treated. Every patient will receive drug treatment, there is no placebo group. Patients will receive different dosages of BAY2010112 to determine the safety, tolerability and maximum tolerated dose (MTD) of BAY2010112. The study will also assess the pharmacokinetics and the clinical efficacy of BAY2010112. BAY2010112 will be given daily as subcutaneous injection or as continuous intravenous infusion. Treatment will be stopped if the tumor continues to grow, if side effects, which the patient cannot tolerate, occur or if the patient decides to exit treatment.
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