First-in-man Dose Escalation Study of BAY2010112 in Patients With Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT01723475|
Recruitment Status : Completed
First Posted : November 8, 2012
Last Update Posted : September 27, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostatic Neoplasms||Biological: BAY2010112||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||47 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||November 2, 2012|
|Actual Primary Completion Date :||July 18, 2018|
|Actual Study Completion Date :||September 26, 2018|
|Experimental: BAY2010112 (s.c.)||
Subcutaneous (s.c.) administration once daily. Starting dose will be 0.5 µg ; dose will be escalated dependent on any dose limiting toxicities
|Experimental: BAY2010112 (c.i.v.)||
Continuous intravenous infusion (c.i.v.) administration. Starting dose will be 5 µg ; dose will be escalated dependent on any dose limiting toxicities.
- Number of participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Up to 2 years or longer if indicated ]
- Maximum Tolerated Dose (MTD) [ Time Frame: Up to 2 years or longer if indicated ]MTD is measured by adverse event profile at the end of Cycle 1. MTD will be the highest dose level achieved during dose escalation where the incidence of dose-limiting toxicities (DLTs) is below 20%
- Maximum drug concentration (Cmax) of BAY2010112 in serum after single and multiple doses administration [ Time Frame: Cycle 1 Day1 and 15; (1 Cycle is 21 days long) ]
- Area under the concentration versus time curve (AUC) from zero to infinity after single (first) and multiple doses of BAY2010112 [ Time Frame: Cycle 1 (1 Cycle is 21 days long) ]
- Tumor response [ Time Frame: Up to 2 years or longer if indicated ]Tumor response is measured by measurable lesions
- Prostate-specific antigen (PSA) response [ Time Frame: Up to 2 years or longer if indicated ]PSA response is measured by maximum decline in PSA that occurs at any point after treatment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01723475
|Linz, Oberösterreich, Austria, 4010|
|Wien, Austria, 1100|
|Heidelberg, Baden-Württemberg, Germany, 69120|
|Würzburg, Bayern, Germany, 97080|
|Berlin, Germany, 12200|
|Study Director:||Bayer Study Director||Bayer|