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

ID: NCT01723475
Status: Active, not recruiting
Phase: Phase 1
Start Date: October 25, 2012
First Submitted: November 01, 2012
Last Updated: February 13, 2018
Results: N/A
Organization: Bayer
Sponsors & Collaborators: Bayer
Location: Austria, Germany
Conditions: Prostatic Neoplasms
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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

Condition or disease Intervention/treatment Phase

Prostatic Neoplasms

Biological: BAY2010112
Other Names
Biological: BAY2010112
Other Names
Phase 1

Tracking Information

First Submitted DateNovember 01, 2012
Last Update Posted DateFebruary 13, 2018
Actual Start DateOctober 25, 2012
Anticipated Completion DateDecember 28, 2018
Actual Primary Completion DateDecember 28, 2018
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • 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

Not Available

Current Secondary Outcome Measures

  • 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

Not Available

Study Design

Brief TitleFirst-in-man Dose Escalation Study of BAY2010112 in Patients With Prostate Cancer
Official TitleAn 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

Study TypeInterventional
Study PhasePhase 1
Estimated Enrollment
45
Allocation
Non-Randomized
Interventional Model
Single Group Assignment
Masking
None (Open Label)
Primary Purpose
Treatment
Conditions
Prostatic Neoplasms
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
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

Other Names
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.

Other Names
Study Groups/Cohorts
BAY2010112 (s.c.)

BAY2010112 (c.i.v.)

Study Arms
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.

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

Arm Intervention/Treatment
Experimental BAY2010112 (c.i.v.)
Biological : BAY2010112
Experimental BAY2010112 (s.c.)
Biological : BAY2010112

Recruitment Information

Recruitment Status:Active, not recruiting
Enrollment45
Completion DateDecember 28, 2018
Eligibility Criteria: 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
GenderMale
Age18 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Not Available
Listed Location Countries
Austria
Germany

Administrative Information

NCT Number:NCT01723475
Other Study ID Numbers
15590
2012-000691-42
Has Data Monitoring CommitteeYes
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
Bayer
Collaborators
Not Available
Investigators
Study Director
Bayer Study Director
Bayer