Spots Global Cancer Trial Database for First-in-man Dose Escalation Study of BAY2010112 in Patients With Prostate Cancer
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Trial Identification
Brief Title: First-in-man Dose Escalation Study of BAY2010112 in Patients With Prostate Cancer
Official Title: An Open-label, Phase I, Dose-escalation Study to Characterize the Safety, Tolerability, Pharmacokinetics, and Maximum Tolerated Dose of BAY 2010112, Given Once Daily by Subcutaneous Administration or by Continuous Intravenous Infusion, in Subjects With Castration-resistant Prostate Cancer
Study ID: NCT01723475
Conditions
Study Description
Brief Summary: 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.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
, Linz, Oberösterreich, Austria
, Wien, , Austria
, Heidelberg, Baden-Württemberg, Germany
, Würzburg, Bayern, Germany
, Berlin, , Germany
Contact Details
Name: Bayer Study Director
Affiliation: Bayer
Role: STUDY_DIRECTOR
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