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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01723475
Recruitment Status : Completed
First Posted : November 8, 2012
Last Update Posted : September 27, 2019
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Prostatic Neoplasms Biological: BAY2010112 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: BAY2010112 (s.c.) Biological: BAY2010112
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.) Biological: BAY2010112
Continuous intravenous infusion (c.i.v.) administration. Starting dose will be 5 µg ; dose will be escalated dependent on any dose limiting toxicities.

Primary Outcome Measures :
  1. Number of participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Up to 2 years or longer if indicated ]
  2. 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%

Secondary Outcome Measures :
  1. 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) ]
  2. 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) ]
  3. Tumor response [ Time Frame: Up to 2 years or longer if indicated ]
    Tumor response is measured by measurable lesions

  4. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male subjects, aged >/= 18 years
  • Subjects with histologically or cytologically proven advanced castration-resistant prostate cancer (CRPC)

    • who failed at least 1 taxane regimen and are refractory to abiraterone and/or enzalutamide therapy OR
    • who have actively refused any treatment which would be regarded standard.
  • Subjects should have undergone bilateral orchiectomy or should be on continuous androgen deprivation therapy with a gonadotropin releasing hormone agonist or antagonist.
  • Subjects must have shown progressive disease after discontinuation of anti-androgen therapy (i.e. flutamide, bicalutamide or nilutamide) before study drug treatment.
  • Total serum testosterone should be less than 50 ng/ml or 1.7 nmol/L
  • Evidence of progressive disease, defined as one or more (Prostate Cancer Working Group 2 (PCWG2) criteria):
  • PSA level of at least 2 ng/ml that has risen on at least 2 successive occasions at least 1 week apart
  • Nodal (in lymph nodes >/= 2cm) or visceral progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST)
  • Appearance of one more new lesions in bone scan
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2
  • Life expectancy of at least 3 months

Exclusion Criteria:

  • Any anticancer therapy or immunotherapy within 4 weeks of start of first dose
  • Confirmed history or current autoimmune disease or other diseases resulting in permanent immunosuppression or requiring permanent immunosuppressive therapy
  • Prior radiotherapy (local palliative radiotherapy is permitted)
  • History of allergic reactions to monoclonal antibody therapy
  • History of clinical significant cardiac disease: including unstable angina, acute myocardial infarction within 6 months prior to first study treatment, congestive heart failure ≥New York Heart Association (NYHA) Class III), and arrhythmia requiring therapy except for beta-blockers, calcium channel blockers and digoxin or uncontrolled hypertension, despite optimal medical management
  • Clinically relevant findings in the electrocardiogram (ECG) such as a second- or third-degree AV block, prolongation of the QRS complex over 120 msec or of the QT interval corrected for heart rate (QTc)-interval over 450 msec
  • Current evidence or history of uncured (i.a. any absolute risk of latent infection) of hepatitis B or C or human immunodeficiency virus (HIV) infection
  • Chronic systemic corticosteroid therapy or any other immunosuppressive therapies should have been stopped at screening start
  • Seizure disorder requiring therapy (such as steroids or anti-epileptics)
  • Subjects unable to inject the study drug subcutaneously for intended s.c. application
  • Non-suitable for a central venous access for intended c.i.v. administration

Information from the National Library of Medicine

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 identifier (NCT number): NCT01723475

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Linz, Oberösterreich, Austria, 4010
Wien, Austria, 1100
Heidelberg, Baden-Württemberg, Germany, 69120
Würzburg, Bayern, Germany, 97080
Berlin, Germany, 12200
Sponsors and Collaborators
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Study Director: Bayer Study Director Bayer

Additional Information:
Publications of Results:
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Responsible Party: Bayer Identifier: NCT01723475    
Other Study ID Numbers: 15590
2012-000691-42 ( EudraCT Number )
First Posted: November 8, 2012    Key Record Dates
Last Update Posted: September 27, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bayer:
Phase I
Dose Escalation
Prostate cancer
Bispecific T-cell Engager (BiTE)
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases