Study Completed

Prostatic Neoplasms

Bayer Identifier:

15590

ClinicalTrials.gov Identifier:

NCT01723475

EudraCT Number:

2012-000691-42

EU CT Number:

Not Available

First-in-man dose escalation study of BAY2010112 in patients with prostate cancer

Trial purpose

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.

Key Participants Requirements

Sex

Male

Age

18 - N/A

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

Trial summary

Enrollment Goal

Trial Dates

November 2012 - September 2018

Phase

Phase 1

Could I Receive a placebo

Products

BAY2010112

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed		Würzburg, 97080, Germany
Completed		Heidelberg, 69120, Germany
Completed		Linz, 4010, Austria
Completed		Berlin, 12200, Germany
Completed		Wien, 1100, Austria

Primary Outcome

Number of participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame:
Up to 2 years or longer if indicated
Safety Issue:
Yes
Maximum Tolerated Dose (MTD)
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%
Time Frame:
Up to 2 years or longer if indicated
Safety Issue:
Yes

Secondary Outcome

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)
Safety Issue:
Yes
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)
Safety Issue:
Yes
Tumor response
Tumor response is measured by measurable lesions
Time Frame:
Up to 2 years or longer if indicated
Safety Issue:
No
Prostate-specific antigen (PSA) response
PSA response is measured by maximum decline in PSA that occurs at any point after treatment
Time Frame:
Up to 2 years or longer if indicated
Safety Issue:
No

Trial design

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

Trial Type

Interventional

Intervention Type

Biological/Vaccine

Trial Purpose

Treatment

Allocation

Non-randomized

Blinding

Open Label

Assignment

Single Group Assignment

Trial Arms

Additional Information

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