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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.
 
ClinicalTrials.gov Identifier: NCT01723475
Recruitment Status : Completed
First Posted : November 8, 2012
Last Update Posted : September 27, 2019
Sponsor:
Information provided by (Responsible Party):
Bayer

Tracking Information
First Submitted Date  ICMJE November 1, 2012
First Posted Date  ICMJE November 8, 2012
Last Update Posted Date September 27, 2019
Actual Study Start Date  ICMJE November 2, 2012
Actual Primary Completion Date July 18, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 6, 2012)
  • 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%
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 6, 2012)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE First-in-man Dose Escalation Study of BAY2010112 in Patients With Prostate Cancer
Official Title  ICMJE 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
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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostatic Neoplasms
Intervention  ICMJE
  • 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
  • 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.
Study Arms  ICMJE
  • Experimental: BAY2010112 (s.c.)
    Intervention: Biological: BAY2010112
  • Experimental: BAY2010112 (c.i.v.)
    Intervention: Biological: BAY2010112
Publications * Frankel SR, Baeuerle PA. Targeting T cells to tumor cells using bispecific antibodies. Curr Opin Chem Biol. 2013 Jun;17(3):385-92. doi: 10.1016/j.cbpa.2013.03.029. Epub 2013 Apr 25. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 10, 2018)
47
Original Estimated Enrollment  ICMJE
 (submitted: November 6, 2012)
80
Actual Study Completion Date  ICMJE September 26, 2018
Actual Primary Completion Date July 18, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01723475
Other Study ID Numbers  ICMJE 15590
2012-000691-42 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bayer
Study Sponsor  ICMJE Bayer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP