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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01723475
• Date of registration: 01/11/2012
• Prospective Registration: Yes
• Primary sponsor: Bayer
• Public title: First-in-man Dose Escalation Study of BAY2010112 in Patients With Prostate Cancer
• Scientific 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
• Date of first enrolment: November 2, 2012
• Target sample size: 47
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01723475
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

Austria, Germany

Contacts

• Name: Bayer Study Director
• Affiliation: Bayer

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Male

Health Condition(s) or Problem(s) studied

Prostatic Neoplasms

Intervention(s)

Biological: BAY2010112

Primary Outcome(s)

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]

Secondary Outcome(s)

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)]

Prostate-specific antigen (PSA) response [Time Frame: Up to 2 years or longer if indicated]

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]

Secondary ID(s)

2012-000691-42

15590

Source(s) of Monetary Support

Please refer to primary and secondary sponsors