A Study to Determine the Safety, Tolerability, Pharmacoki... | NCT00958477

Label	Type	Description	Intervention Names
EMD 525797	Experimental		Biological: EMD 525797

Name	Type	Description	Arm Group Labels	Other Names
EMD 525797	Biological	Subjects will be administered with 250 milligram (mg), 500 mg, 1000 mg or 1500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who will be clinically benefitted at the end of week 6 were continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject is no longer benefitted from the treatment as per Investigator's discretion.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Subjects With Dose Limiting Toxicity (DLT)	DLT was defined using National Cancer Institute Common Toxicity Criteria for Adverse Events Version 3.0 as any Grade 3 or 4 hematological or non-hematological toxicity occurring at any dose level until the end of Week 6, and suspected to be reasonably related to the investigational product by the Investigator and/or Sponsor except for allergic/ hypersensitivity reactions and any Grade 3/4 out-of-range laboratory values without any clinical correlate, which were reversible within 7 days.	Baseline up to 6 weeks
Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and Related TEAEs	An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug or worsening of pre-existing medical condition, whether or not related to study drug. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Treatment-emergent are events between first dose of study drug that were absent before treatment or that worsened relative to pre-treatment state. TEAEs include both Serious TEAEs and non-serious TEAEs.Treatment-related are events which had causal relationship to study drug as assessed by the Investigator and were suspected to be reasonably related to the study drug.	Baseline up to 534 days
Observed Maximum Serum Concentration (Cmax) of EMD 525797 After First Infusion		pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 1
Observed Maximum Serum Concentration (Cmax) of EMD 525797 After Third Infusion		pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 5

Secondary Outcomes

Measure	Description	Time Frame
Time to Reach Observed Serum Concentration (Tmax) After First Infusion		pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 1
Time to Reach Observed Serum Concentration (Tmax) After Third Infusion		pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 5

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Provision of signed written informed consent
Age superior or equal to 18 years
Subjects with histological or cytologically proven prostate cancer with evidence of bone metastases on bone scans or CT / MRI after prior chemotherapy with e.g. taxane or mitoxantrone Patients should have undergone bilateral orchiectomy or should be on continuous androgen deprivation therapy with a gonadotropin releasing hormone agonist or antagonist and should have stopped any anti-androgen therapy for at least 4 weeks before inclusion in the study. Patients should be either on stable (i.e., since at least 3 months) ongoing therapy with a bisphosphonate or without any bisphosphonate therapy. Initiation of a bisphosphonate therapy within this time period prior the study or during the study is not allowed. Total serum testosterone should be less than 50 ng/dL or 1.7 nmol/L.
Evidence of progressive disease, defined by at least two PSA values above the individual nadir level with an increase of at least 10% each determined at a minimum interval of 2 weeks before screening examination. Presence of a measurable lesion is not required for study entry. Nodal (in lymph nodes superior or equal to 2cm) or visceral progression is sufficient for trial entry independent of PSA.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 at study entry and an estimated life expectancy of at least 3 months.
Adequate hematological function, defined by white blood cell count (WBC) greater than or equal to 3 x 109/L with absolute neutrophil count (ANC) greater than or equal to 1.5 x 109/L, and lymphocyte count greater than or equal to 0.5 x 109/L; platelet count greater than or equal to 100 x 109/L; and hemoglobin greater than or equal to 9 g/dL.
Adequate hepatic function defined by total bilirubin level less than or equal to 1.5 times the upper limit of normal (ULN), and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels less than or equal to 2.5 x ULN; or, for subjects with documented metastatic disease to the liver, AST and ALT levels less than or equal to 5 x ULN.
Adequate renal function defined by serum creatinine less than 1.5 mg/dL.
Effective contraception. If the risk of conception exists, pregnancy has to be avoided during the study (SCR to EOS) as well as during at least 3 month after last dosing using an effective contraception method (e.g. double barrier method)

Exclusion Criteria:

Any systemic cytotoxic cancer treatment within 4 weeks before treatment with EMD 525797.
Acute pathologic fracture, spinal cord progression, hypercalcemia (within 4 weeks period prior to screening).
Radiotherapy to bone lesions, orthopaedic surgery, or any investigational drug in the 30 days before the start of treatment in this study and during treatment period, and/or biopsies involving bone within 2 weeks before the start of treatment in this study.
Supraphysiologic doses of steroids (defined as superior or equal to 7.5 mg of prednisone equivalents per day).
Previous treatment with anti-integrin therapy.
Confirmed or clinically suspected brain metastases.
Known hypersensitivity reactions to any of the components of the study medication.
History of allergic reactions to other monoclonal antibody (mAb) therapy.
Uncontrolled hypertension (systolic greater or equal to 160 mmHg, diastolic greater than or equal to 100 mmHg).
Current history of chronic daily aspirin therapy (ASS at doses inferior or equal to 100 mg is permitted), bleeding disorders and/or history of thromboembolic events (history of superficial thrombophlebitis is not an exclusion criterion); thrombolytics or oral or parenteral anticoagulants within 10 days prior to study start and during treatment period.
Severe peripheral vascular disease or ulceration.
Unstable angina pectoris, or myocardial infarction within 6 months before start of study treatment, clinical significant abnormal ECG at screening
Known alcohol or drug abuse.
Participation in another clinical trial within the past 30 days before start of study treatment.
Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.
Ongoing uncontrolled infections, including active or chronic hepatitis B or C, ongoing HIV infection.
Legal incapacity or limited legal capacity.
All other significant diseases which, in the opinion of the Investigator, might impair the subject's tolerance of study treatment.

Name	Affiliation	Role
Wolfgang Uhl, Dr, Dipl. Chem., Physician	Merck KGaA, Darmstadt, Germany	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Institut Jules Bordet - Medical Oncology Clinic		Brussels			Belgium
Universitätsklinikum Aachen, AÖR - Medizinische Fakultät der RWTH - Klinik für Urologie

PubMed Identifier	Type	Citation	Retractions
23791392	Derived	Wirth M, Heidenreich A, Gschwend JE, Gil T, Zastrow S, Laniado M, Gerloff J, Zuhlsdorf M, Mordenti G, Uhl W, Lannert H. A multicenter phase 1 study of EMD 525797 (DI17E6), a novel humanized monoclonal antibody targeting alphav integrins, in progressive castration-resistant prostate cancer with bone metastases after chemotherapy. Eur Urol. 2014 May;65(5):897-904. doi: 10.1016/j.eururo.2013.05.051. Epub 2013 Jun 6.

ID	Title	Description
FG000	EMD 525797 250 mg	Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Subjects With Dose Limiting Toxicity (DLT)

DLT was defined using National Cancer Institute Common Toxicity Criteria for Adverse Events Version 3.0 as any Grade 3 or 4 hematological or non-hematological toxicity occurring at any dose level until the end of Week 6, and suspected to be reasonably related to the investigational product by the Investigator and/or Sponsor except for allergic/ hypersensitivity reactions and any Grade 3/4 out-of-range laboratory values without any clinical correlate, which were reversible within 7 days.

DLT analysis set: all subjects who experienced any DLT during first 6 weeks, regardless of number of doses of drug administered or who were considered completers (did not discontinue treatment for any reason other than DLT, were compliant, did not deviate in drug administration for more than +/-2 days due to any reason other than related toxicity).

Posted

Number

subjects

Baseline up to 6 weeks

ID	Title	Description
OG000	EMD 525797 250 mg	Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.
OG001	EMD 525797 500 mg	Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.
OG002	EMD 525797 1000 mg	Subjects were administered with 1000 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.
OG003	EMD 525797 1500 mg	Subjects were administered with 1500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.

Units	Counts
Participants	OG0008 OG0016 OG0026 OG003

Title

Denominators

Categories

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Primary

Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and Related TEAEs

An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug or worsening of pre-existing medical condition, whether or not related to study drug. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Treatment-emergent are events between first dose of study drug that were absent before treatment or that worsened relative to pre-treatment state. TEAEs include both Serious TEAEs and non-serious TEAEs.Treatment-related are events which had causal relationship to study drug as assessed by the Investigator and were suspected to be reasonably related to the study drug.

Safety analysis set included all subjects who received at least 1 dose of the study medication and had at least 1 follow-up safety measure.

Posted

Number

Subjects

Baseline up to 534 days

ID	Title	Description
OG000	EMD 525797 250 mg	Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.

Primary

Observed Maximum Serum Concentration (Cmax) of EMD 525797 After First Infusion

Pharmacokinetic (PK) analysis set included all subjects who received at least first dose of the study drug according to the protocol and who provided sufficient data for a concentration time profile for EMD 525797.Here "Number of Participants analyzed" signifies those subjects who were evaluable for this outcome measure for each arm, respectively.

Posted

Geometric Mean

Geometric Coefficient of Variation

microgram per milliliter (mcg/mL)

pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 1

ID	Title	Description
OG000	EMD 525797 250 mg	Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.
OG001	EMD 525797 500 mg	Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.

Primary

Observed Maximum Serum Concentration (Cmax) of EMD 525797 After Third Infusion

PK analysis set included all subjects who received at least the first dose of the study drug according to the protocol and who provided sufficient data for a concentration time profile for EMD 525797. Here "Number of Participants analyzed" signifies those subjects who were evaluable for this outcome measure for each arm, respectively.

Posted

Geometric Mean

Geometric Coefficient of Variation

mcg/mL

pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 5

ID	Title	Description
OG000	EMD 525797 250 mg	Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.
OG001	EMD 525797 500 mg	Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.
OG002

Primary

Area Under the Serum Concentration-time Curve From Time Zero to the Last Sampling Time (AUC0-t) After First Infusion

Area under the serum concentration-time curve from time zero to the last sampling time at which the concentration is at or above lower limit of quantification (LLQ). AUC0-t was calculated according to the mixed log linear trapezoidal rule.

Posted

Geometric Mean

Geometric Coefficient of Variation

h*mcg/mL

pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 1

ID	Title	Description
OG000	EMD 525797 250 mg	Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.
OG001	EMD 525797 500 mg	Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.

Primary

Total Body Clearance of Drug From Serum (CL) After First Infusion

Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Total body clearance of drug from serum, calculated as CL = dose/AUC0-inf. Where AUC0-inf is area under the serum concentration time curve from time zero to infinity, calculated as AUC0 t + AUCextra. AUCextra represents an extrapolated value obtained by Clast/λz, where Clast is the calculated serum concentration at the last sampling time point at which the measured serum concentration is at or above lower limit of quantification (LLQ) and λz is elimination rate constant.

Posted

Geometric Mean

Geometric Coefficient of Variation

L/h

pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 1

ID	Title	Description
OG000	EMD 525797 250 mg	Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.
OG001

Primary

Apparent Volume of Distribution During Terminal Phase (Vz) of EMD 525797 After First Infusion

Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Apparent volume of distribution during the terminal phase, calculated as = Dose/(AUC0-inf *λz) after first infusion. Where 'λz' is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Where AUC0-inf is area under the serum concentration time curve from time zero to infinity, calculated as AUC0 t + AUCextra. AUCextra represents an extrapolated value obtained by Clast/λz, where Clast is the calculated serum concentration at the last sampling time point at which the measured serum concentration is at or above lower limit of quantification (LLQ) and λz is elimination rate constant.

Posted

Geometric Mean

Geometric Coefficient of Variation

Liters

pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 1

ID	Title	Description
OG000	EMD 525797 250 mg	Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.

Primary

Trough Serum Concentration (Ctrough) Of EMD 525797 at Week 1

Ctrough is the concentration prior to study drug administration.

Posted

Mean

Standard Deviation

mcg/mL

pre-dose at Week 1

ID	Title	Description
OG000	EMD 525797 250 mg	Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.
OG001	EMD 525797 500 mg	Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.
OG002

Primary

Trough Serum Concentration (Ctrough) Of EMD 525797 at Week 3

Ctrough is the concentration prior to study drug administration.

Posted

Mean

Standard Deviation

mcg/mL

pre-dose at Week 3

ID	Title	Description
OG000	EMD 525797 250 mg	Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.
OG001	EMD 525797 500 mg	Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.
OG002

Primary

Trough Serum Concentration (Ctrough) Of EMD 525797 at Week 5

Ctrough is the concentration prior to study drug administration.

Posted

Mean

Standard Deviation

mcg/mL

pre-dose at Week 5

ID	Title	Description
OG000	EMD 525797 250 mg	Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.
OG001	EMD 525797 500 mg	Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.
OG002

Secondary

Time to Reach Observed Serum Concentration (Tmax) After First Infusion

Posted

Median

Full Range

hours

pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 1

ID	Title	Description
OG000	EMD 525797 250 mg	Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.
OG001	EMD 525797 500 mg	Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.
OG002	EMD 525797 1000 mg

Secondary

Time to Reach Observed Serum Concentration (Tmax) After Third Infusion

Posted

Median

Full Range

hours

pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 5

ID	Title	Description
OG000	EMD 525797 250 mg	Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.
OG001	EMD 525797 500 mg	Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.
OG002	EMD 525797 1000 mg

Secondary

Number of Subjects With Positive Anti-EMD 525797 Antibodies

Safety analysis set included all subjects who received at least 1 dose of the study medication and had at least 1 follow-up safety measure.

Posted

Number

Subjects

Week 1, 3, 5, 8, 9

ID	Title	Description
OG000	EMD 525797 250 mg	Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.
OG001	EMD 525797 500 mg	Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.
OG002	EMD 525797 1000 mg	Subjects were administered with 1000 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.

Secondary

Serum Levels of Interleukin 6 (IL-6) and Interleukin 8 (IL-8)

As per change in planned analysis, it was decided that that the biomarker analysis were not significantly associated with compound administration and thus the data was not collected for this outcome.

Posted

Week 1 up to a maximum of 56 days

ID	Title	Description
OG000	EMD 525797 250 mg	Subjects were administered with 250 milligram (mg) mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who will be clinically benefitted at the end of Week 6 will continue at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.
OG001	EMD 525797 500 mg	Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who will be clinically benefitted at the end of Week 6 will continue at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.
OG002	EMD 525797 1000 mg	Subjects were administered with 1000 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who will be clinically benefitted at the end of Week 6 will continue at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.

Secondary

C-Reactive Protein Levels

As per change in planned analysis, it was decided that that the biomarker analysis were not significantly associated with compound administration and thus the data was not collected for this outcome.

Posted

Week 1 up to a maximum of 56 days

ID	Title	Description
OG000	EMD 525797 250 mg	Subjects were administered with 250 milligram (mg) mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who will be clinically benefitted at the end of Week 6 will continue at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.
OG001	EMD 525797 500 mg	Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who will be clinically benefitted at the end of Week 6 will continue at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.
OG002	EMD 525797 1000 mg	Subjects were administered with 1000 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who will be clinically benefitted at the end of Week 6 will continue at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.

Secondary

Apparent Terminal Half-life (t1/2) of EMD 525797 After First Infusion

Terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life is calculated by dividing the natural logarithm to the base e (Log e) multiplied by (*) 2/ λz, where 'λz' is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.

Posted

Median

Full Range

hours

pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 1

ID	Title	Description
OG000	EMD 525797 250 mg	Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.
OG001	EMD 525797 500 mg	Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.

Secondary

Elimination Rate Constant (λz) of EMD 525797 After First Infusion

Elimination rate constant obtained from linear regression of the terminal phase of the log transformed concentration-time data.

PK analysis set included all subjects who received at least first dose of the study drug according to the protocol and who provided sufficient data for a concentration time profile for EMD 525797. Here "Number of Participants analyzed" signifies those subjects who were evaluable for this outcome measure for each arm, respectively.

Posted

Geometric Mean

Geometric Coefficient of Variation

1/h

pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 1

ID	Title	Description
OG000	EMD 525797 250 mg	Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.
OG001	EMD 525797 500 mg	Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.

Secondary

Observed Minimum Serum Concentration (Cmin) of EMD 525797 After Third Infusion

Observed minimum serum concentration determined directly from the serum concentration-time profile of each subject.

Posted

Mean

Standard Deviation

mcg/mL

pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 5

ID	Title	Description
OG000	EMD 525797 250 mg	Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.
OG001	EMD 525797 500 mg	Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.

Secondary

Average Serum Concentration at Steady State (Cav) of EMD 525797 After Third Infusion

The average serum concentration at steady state, calculated as Cav = AUCtau/tau, where tau is the dosing interval (336 hours).

Posted

Geometric Mean

Geometric Coefficient of Variation

mcg/mL

pre-dose, end of infusion, 4, 8, 24, 48, 96, 168, 336 hours post third infusion at Week 5

ID	Title	Description
OG000	EMD 525797 250 mg	Subjects were administered with 250 milligram (mg) mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who will be clinically benefitted at the end of Week 6 will continue at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.
OG001	EMD 525797 500 mg	Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.

Secondary

Area Under the Serum Concentration-time Curve Within One Complete Dosing Interval (AUCtau) of EMD 525797 After First Infusion

Area under the concentration-time curve from time zero up to time Tau, where Tau is the dosing interval (168 hours).

Posted

Geometric Mean

Geometric Coefficient of Variation

h*mcg/mL

pre-dose, end of infusion, 4, 8, 24, 48, 96 and 168 hours post-infusion at Week 1

ID	Title	Description
OG000	EMD 525797 250 mg	Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.
OG001	EMD 525797 500 mg	Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.

Secondary

Area Under the Serum Concentration-time Curve Within One Complete Dosing Interval (AUCtau) of EMD 525797 After Third Infusion

Area under the concentration-time curve from time zero up to time Tau, where Tau is the dosing interval (336 hours).

Posted

Geometric Mean

Geometric Coefficient of Variation

h*mcg/mL

pre-dose, end of infusion, 4, 8, 24, 48, 96,168, 336 hours post third infusion at Week 5

ID	Title	Description
OG000	EMD 525797 250 mg	Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.
OG001	EMD 525797 500 mg	Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.

Secondary

Area Under the Serum Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of EMD 525797 After First Infusion

Area under the serum concentration time curve from time zero to infinity, calculated as AUC0 t + AUCextra. AUCextra represents an extrapolated value obtained by Clast/λz, where Clast is the calculated serum concentration at the last sampling time point at which the measured serum concentration is at or above LLQ and λz is elimination rate constant.

Posted

Geometric Mean

Geometric Coefficient of Variation

h*mcg/mL

pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 1

ID	Title	Description
OG000	EMD 525797 250 mg	Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.
OG001	EMD 525797 500 mg	Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.

Secondary

Peak Trough Fluctuation Over One Dosing Interval at Steady State (%PTF) of EMD 525797 After Third Infusion

The peak trough fluctuation over one dosing interval at steady state, calculated as PTF (%) = ( [ Cmax - Cmin ] / Cav )*100

Posted

Geometric Mean

Geometric Coefficient of Variation

percentage of fluctuation

pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 5

ID	Title	Description
OG000	EMD 525797 250 mg	Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.
OG001	EMD 525797 500 mg	Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.

Secondary

Mean Residence Time of Drug in the Body (MRT) of EMD 525797 After First Infusion

Mean residence time of drug in the body calculated as: AUMC0-inf / AUC0-inf, where AUMC0-inf is the area under the first moment curve from time zero to infinity. Where AUC0-inf is area under the serum concentration time curve from time zero to infinity, calculated as AUC0 t + AUCextra. AUCextra represents an extrapolated value obtained by Clast/λz, where Clast is the calculated serum concentration at the last sampling time point at which the measured serum concentration is at or above lower limit of quantification (LLQ) and λz is elimination rate constant.

Posted

Geometric Mean

Geometric Coefficient of Variation

hours

pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 1

ID	Title	Description
OG000	EMD 525797 250 mg	Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.
OG001

Secondary

Apparent Volume of Distribution at Steady State (Vss) of EMD 525797 After Third Infusion

Apparent volume of distribution at steady-state was reported. Apparent volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug.

Posted

Geometric Mean

Geometric Coefficient of Variation

Liters

pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 5

ID	Title	Description
OG000	EMD 525797 250 mg	Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.
OG001	EMD 525797 500 mg	Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.

Secondary

Accumulation Ratio Of Cmax (R_Cmax)

Accumulation ratio for Cmax was calculated as Cmax, after third dose/Cmax, after first dose.

Posted

Geometric Mean

Geometric Coefficient of Variation

ratio

pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 1 and Week 5

ID	Title	Description
OG000	EMD 525797 250 mg	Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.
OG001	EMD 525797 500 mg	Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.

Secondary

Accumulation Ratio of AUC (R_AUC)

Accumulation ratio for AUC, calculated as area under the serum concentration-time curve within one complete dosing interval at third dose divided by area under the serum concentration-time curve within one complete dosing interval at first dose.

Posted

Geometric Mean

Geometric Coefficient of Variation

ratio

pre-dose, end of infusion, 4, 8, 24, 48, 96,168 hours post-infusion at Week 1 and pre-dose, end of infusion, 4, 8, 24, 48, 96, 168, 336 hours post third infusion at Week 5

ID	Title	Description
OG000	EMD 525797 250 mg	Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.
OG001	EMD 525797 500 mg	Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.

Secondary

Number of Subjects With Best Overall Response (BOR)

Number of subjects with BOR in each category (complete response [CR], partial response [PR], stable disease [SD], progressive disease [PD]) according to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.0) was reported. CR: defined as disappearance of all target and all non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: defined as at least a 30% decrease in sum of longest diameter of target lesions, taking as reference the baseline sum of longest diameter. PD:defined as at least a 20% increase in sum of longest diameter of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study) or unequivocal progression of existing non-target lesions. SD: defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of longest diameter while on study.

Efficacy analysis set included all subjects who received at least 1 dose of the study drug.

Posted

Number

subjects

Week 6, Week 19, Overall (Baseline Up to 394 days)

ID	Title	Description
OG000	EMD 525797 250 mg	Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.

Secondary

Progression-free Survival (PFS) as Per Prostate Cancer Clinical Trials Working Group 1 (PCWG1) and Prostate Cancer Clinical Trials Working Group 2 (PCWG2) Criteria

PFS PCWG1 criteria: time from the day treatment is initiated up to progression (for subject's whose prostate specific antigen [PSA] level did not decrease after baseline, progression defined as 50% PSA increase relative to baseline; for subject's whose PSA decreased after baseline, progression defined as 50% PSA increase relative to nadir [smallest PSA value post-baseline]. Progression was confirmed if progression criterion was met in next 2 assessments as well.) PFS PCWG2 criteria: time from study entry to disease progression or death. Progression was defined as first appearance of progression according to PSA (for subject's whose PSA decreased after baseline, progression was defined as 25% PSA increase relative to nadir. Progression was confirmed if another assessment measured at least 3 weeks later met the criterion as well; for subject's whose PSA did not decrease after baseline, progression was defined as 25% PSA increase relative to baseline assessed 12 weeks after baseline).

Efficacy analysis set included all subjects who received at least 1 dose of the study drug.

Posted

Median

95% Confidence Interval

months

Baseline up to 394 days

ID	Title	Description
OG000	EMD 525797 250 mg	Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.

Secondary

Time to Progression (TTP)

TTP was calculated as the time between the date of imaging for the earliest visit where progressive disease was detected and the first dose date plus 1 day. Participants without event are censored on the date of last tumor assessment.

Efficacy analysis set included all subjects who received at least 1 dose of the study drug. Here "Number of Participants" analyzed signifies those subjects who were evaluable for this outcome measure.

Posted

Number

months

Baseline up to disease progression up to a maximum of 13.1 months

ID	Title	Description
OG000	EMD 525797 250 mg	Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.
OG001	EMD 525797 500 mg	Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.

Secondary

Number of Subjects With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score vs. Worst Post-baseline Score

ECOG performance status measured to assess subject's performance status on a scale of 0 to 4, where 0=Fully active, able to carry on all pre-disease activities without restriction; 1=Restricted in physically strenuous activity, ambulatory and able to carry out light or sedentary work; 2=Ambulatory (>50% of waking hours), capable of all self-care, unable to carry out any work activities; 3=Capable of only limited self-care, confined to bed/chair >50% of waking hours; 4=Completely disabled, cannot carry on any self-care, totally confined to bed/chair. ECOG performance status was reported in terms of number of subjects with Baseline value vs. worst post-baseline value (i.e. highest score) combination.

Safety analysis set included all subjects who received at least 1 dose of the study medication and had at least 1 follow-up safety measure.

Posted

Number

subjects

Baseline up to 394 days

ID	Title	Description
OG000	EMD 525797 250 mg	Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.
OG001	EMD 525797 500 mg

Secondary

Number of Subjects With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score vs. Best Post-baseline Score

ECOG performance status measured to assess subject's performance status on a scale of 0 to 4, where 0=Fully active, able to carry on all pre-disease activities without restriction; 1=Restricted in physically strenuous activity, ambulatory and able to carry out light or sedentary work; 2=Ambulatory (>50% of waking hours), capable of all self-care, unable to carry out any work activities; 3=Capable of only limited self-care, confined to bed/chair >50% of waking hours; 4=Completely disabled, cannot carry on any self-care, totally confined to bed/chair. ECOG performance status was reported in terms of number of subjects with Baseline value vs. best post-baseline value (i.e. lowest score) combination.

Safety analysis set included all subjects who received at least 1 dose of the study medication and had at least 1 follow-up safety measure.

Posted

Number

subjects

Baseline up to 394 days

ID	Title	Description
OG000	EMD 525797 250 mg	Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.
OG001	EMD 525797 500 mg

Secondary

Total Pain Score Using Brief Pain Inventory-Short Form (BPI-sf)

BPI-sf is an 11-item self-report questionnaire that is designed to assess the severity and impact of pain on daily functions. BPI-sf has 4 questions that assess pain intensity (worst, least, average, right now) and 7 questions that assess impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each question is answered on a scale ranging from 0 to 10;'0=No pain and 10=Pain as bad as you can imagine'.Total score is reported as average of individual questions ranges from 0 to 10, with lower scores being indicative of less pain or pain interference.Data was not available for "EMD 525797 250 mg" arm for FUP Weeks 15, 19, 23, 27, 31, 35, 39, 43, 47, 51, 55, 59, 63, 67, 71, 75 and "EMD 525797 1000 mg" arm for FUP Weeks 47, 51, 55, 59, 63, 67, 71 and "EMD 525797 1500 mg arm" for FUP Weeks 35, 39, 43, 47, 51, 55, 59, 63, 67, 71, 75 respectively as no subjects were evaluable at the specified FUP visits.

Efficacy analysis set included all subjects who received at least 1 dose of the study drug. Here "n" signifies those subjects who were evaluable for this outciome measure at the specified time points.

Posted

Mean

Standard Deviation

score on a scale

Screening; Baseline; Week 3, 5, 7; Follow-up (FUP) Week 11, 15, 19, 23, 27, 31, 35, 39, 43, 47, 51, 55, 59, 63, 67, 71, 75; End of treatment (EOT; maximum up to 380 days) and EOS (maximum up to 394 days)

ID	Title	Description
OG000	EMD 525797 250 mg	Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.

Secondary

Maximum Percent Change From Baseline in Prostate Specific Antigen (PSA) Level

Maximum percent change from Baseline in PSA Level during the study was reported.

Efficacy analysis set included all subjects who received at least 1 dose of the study drug.

Posted

Mean

Standard Deviation

percent change

Baseline up to 394 days

ID	Title	Description
OG000	EMD 525797 250 mg	Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.
OG001	EMD 525797 500 mg	Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.
OG002	EMD 525797 1000 mg	Subjects were administered with 1000 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.

Secondary

Minimum Percent Change From Baseline in PSA Level

Minimum percent change from Baseline in PSA Level during the study was reported.

Efficacy analysis set included all subjects who received at least 1 dose of the study drug.

Posted

Mean

Standard Deviation

percent change

Baseline up to 394 days

ID	Title	Description
OG000	EMD 525797 250 mg	Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.
OG001	EMD 525797 500 mg	Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.
OG002	EMD 525797 1000 mg	Subjects were administered with 1000 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA Version 13.0	Non-systematic Assessment	EG0000 affected8 at risk EG0010 affected6 at risk EG0021 affected6 at risk EG0030 affected6 at risk
Anaemia Of Malignant Disease	Blood and lymphatic system disorders	MedDRA Version 13.0	Non-systematic Assessment	EG0000 affected8 at risk EG0010 affected6 at risk EG0021 affected6 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA Version 13.0	Non-systematic Assessment	EG0001 affected8 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA Version 13.0	Non-systematic Assessment	EG0000 affected8 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Pancreatitis	Gastrointestinal disorders	MedDRA Version 13.0	Non-systematic Assessment	EG0000 affected8 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Upper Gastrointestinal Haemorrhage	Gastrointestinal disorders	MedDRA Version 13.0	Non-systematic Assessment	EG0001 affected8 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Euthanasia	General disorders	MedDRA Version 13.0	Non-systematic Assessment	EG0000 affected8 at risk EG0010 affected6 at risk EG0021 affected6 at risk EG003
Pyrexia	General disorders	MedDRA Version 13.0	Non-systematic Assessment	EG0000 affected8 at risk EG0011 affected6 at risk EG0020 affected6 at risk EG003
Bile Duct Stone	Hepatobiliary disorders	MedDRA Version 13.0	Non-systematic Assessment	EG0000 affected8 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Sepsis	Infections and infestations	MedDRA Version 13.0	Non-systematic Assessment	EG0000 affected8 at risk EG0010 affected6 at risk EG0021 affected6 at risk EG003
Urinary Tract Infection	Infections and infestations	MedDRA Version 13.0	Non-systematic Assessment	EG0000 affected8 at risk EG0010 affected6 at risk EG0021 affected6 at risk EG003
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA Version 13.0	Non-systematic Assessment	EG0000 affected8 at risk EG0010 affected6 at risk EG0021 affected6 at risk EG003
Muscular Weakness	Musculoskeletal and connective tissue disorders	MedDRA Version 13.0	Non-systematic Assessment	EG0001 affected8 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Pain In Extremity	Musculoskeletal and connective tissue disorders	MedDRA Version 13.0	Non-systematic Assessment	EG0000 affected8 at risk EG0010 affected6 at risk EG0021 affected6 at risk EG003
Pain In Jaw	Musculoskeletal and connective tissue disorders	MedDRA Version 13.0	Non-systematic Assessment	EG0000 affected8 at risk EG0010 affected6 at risk EG0021 affected6 at risk EG003
Metastases To Central Nervous System	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 13.0	Non-systematic Assessment	EG0000 affected8 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Paraplegia	Nervous system disorders	MedDRA Version 13.0	Non-systematic Assessment	EG0001 affected8 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Ureteric Obstruction	Renal and urinary disorders	MedDRA Version 13.0	Non-systematic Assessment	EG0001 affected8 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Acute Pulmonary Oedema	Respiratory, thoracic and mediastinal disorders	MedDRA Version 13.0	Non-systematic Assessment	EG0000 affected8 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA Version 13.0	Non-systematic Assessment	EG0000 affected8 at risk EG0010 affected6 at risk EG0021 affected6 at risk EG0031 affected6 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA Version 13.0	Non-systematic Assessment	EG0001 affected8 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA Version 13.0	Non-systematic Assessment	EG0000 affected8 at risk EG0011 affected6 at risk EG0020 affected6 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA Version 13.0	Non-systematic Assessment	EG0001 affected8 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA Version 13.0	Non-systematic Assessment	EG0001 affected8 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Vision Blurred	Eye disorders	MedDRA Version 13.0	Non-systematic Assessment	EG0000 affected8 at risk EG0011 affected6 at risk EG0020 affected6 at risk EG003
Abdominal Pain	Gastrointestinal disorders	MedDRA Version 13.0	Non-systematic Assessment	EG0000 affected8 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Abdominal Pain Upper	Gastrointestinal disorders	MedDRA Version 13.0	Non-systematic Assessment	EG0000 affected8 at risk EG0011 affected6 at risk EG0020 affected6 at risk EG003
Abdominal Tenderness	Gastrointestinal disorders	MedDRA Version 13.0	Non-systematic Assessment	EG0001 affected8 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA Version 13.0	Non-systematic Assessment	EG0000 affected8 at risk EG0010 affected6 at risk EG0021 affected6 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA Version 13.0	Non-systematic Assessment	EG0001 affected8 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Dry Mouth	Gastrointestinal disorders	MedDRA Version 13.0	Non-systematic Assessment	EG0000 affected8 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Hypoaesthesia Oral	Gastrointestinal disorders	MedDRA Version 13.0	Non-systematic Assessment	EG0000 affected8 at risk EG0010 affected6 at risk EG0021 affected6 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA Version 13.0	Non-systematic Assessment	EG0000 affected8 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Swollen Tongue	Gastrointestinal disorders	MedDRA Version 13.0	Non-systematic Assessment	EG0000 affected8 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Toothache	Gastrointestinal disorders	MedDRA Version 13.0	Non-systematic Assessment	EG0001 affected8 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA Version 13.0	Non-systematic Assessment	EG0000 affected8 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Fatigue	General disorders	MedDRA Version 13.0	Non-systematic Assessment	EG0001 affected8 at risk EG0010 affected6 at risk EG0022 affected6 at risk EG003
General Physical Health Deterioration	General disorders	MedDRA Version 13.0	Non-systematic Assessment	EG0001 affected8 at risk EG0010 affected6 at risk EG0021 affected6 at risk EG003
Infusion Site Extravasation	General disorders	MedDRA Version 13.0	Non-systematic Assessment	EG0000 affected8 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Mucosal Inflammation	General disorders	MedDRA Version 13.0	Non-systematic Assessment	EG0000 affected8 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Non-Cardiac Chest Pain	General disorders	MedDRA Version 13.0	Non-systematic Assessment	EG0000 affected8 at risk EG0011 affected6 at risk EG0020 affected6 at risk EG003
Oedema Peripheral	General disorders	MedDRA Version 13.0	Non-systematic Assessment	EG0002 affected8 at risk EG0011 affected6 at risk EG0020 affected6 at risk EG003
Pyrexia	General disorders	MedDRA Version 13.0	Non-systematic Assessment	EG0000 affected8 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Bile Duct Stone	Hepatobiliary disorders	MedDRA Version 13.0	Non-systematic Assessment	EG0000 affected8 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Cystitis	Infections and infestations	MedDRA Version 13.0	Non-systematic Assessment	EG0000 affected8 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Cystitis Escherichia	Infections and infestations	MedDRA Version 13.0	Non-systematic Assessment	EG0000 affected8 at risk EG0010 affected6 at risk EG0021 affected6 at risk EG003
Fungal Infection	Infections and infestations	MedDRA Version 13.0	Non-systematic Assessment	EG0000 affected8 at risk EG0010 affected6 at risk EG0021 affected6 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA Version 13.0	Non-systematic Assessment	EG0000 affected8 at risk EG0010 affected6 at risk EG0021 affected6 at risk EG003
Rhinitis	Infections and infestations	MedDRA Version 13.0	Non-systematic Assessment	EG0001 affected8 at risk EG0011 affected6 at risk EG0020 affected6 at risk EG003
Sinusitis	Infections and infestations	MedDRA Version 13.0	Non-systematic Assessment	EG0000 affected8 at risk EG0010 affected6 at risk EG0021 affected6 at risk EG003
Urinary Tract Infection	Infections and infestations	MedDRA Version 13.0	Non-systematic Assessment	EG0002 affected8 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA Version 13.0	Non-systematic Assessment	EG0000 affected8 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Joint Sprain	Injury, poisoning and procedural complications	MedDRA Version 13.0	Non-systematic Assessment	EG0000 affected8 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Blood Alkaline Phosphatase Increased	Investigations	MedDRA Version 13.0	Non-systematic Assessment	EG0000 affected8 at risk EG0011 affected6 at risk EG0020 affected6 at risk EG003
Blood Creatinine Increased	Investigations	MedDRA Version 13.0	Non-systematic Assessment	EG0001 affected8 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Blood Pressure Increased	Investigations	MedDRA Version 13.0	Non-systematic Assessment	EG0000 affected8 at risk EG0011 affected6 at risk EG0020 affected6 at risk EG003
Gamma-Glutamyltransferase Increased	Investigations	MedDRA Version 13.0	Non-systematic Assessment	EG0001 affected8 at risk EG0011 affected6 at risk EG0020 affected6 at risk EG003
Haemoglobin Decreased	Investigations	MedDRA Version 13.0	Non-systematic Assessment	EG0000 affected8 at risk EG0011 affected6 at risk EG0020 affected6 at risk EG003
Weight Decreased	Investigations	MedDRA Version 13.0	Non-systematic Assessment	EG0000 affected8 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Decreased Appetite	Metabolism and nutrition disorders	MedDRA Version 13.0	Non-systematic Assessment	EG0000 affected8 at risk EG0010 affected6 at risk EG0021 affected6 at risk EG003
Diabetes Mellitus	Metabolism and nutrition disorders	MedDRA Version 13.0	Non-systematic Assessment	EG0000 affected8 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA Version 13.0	Non-systematic Assessment	EG0000 affected8 at risk EG0011 affected6 at risk EG0020 affected6 at risk EG003
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA Version 13.0	Non-systematic Assessment	EG0000 affected8 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA Version 13.0	Non-systematic Assessment	EG0001 affected8 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Hypovolaemia	Metabolism and nutrition disorders	MedDRA Version 13.0	Non-systematic Assessment	EG0000 affected8 at risk EG0011 affected6 at risk EG0020 affected6 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA Version 13.0	Non-systematic Assessment	EG0001 affected8 at risk EG0012 affected6 at risk EG0021 affected6 at risk EG003
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA Version 13.0	Non-systematic Assessment	EG0002 affected8 at risk EG0011 affected6 at risk EG0021 affected6 at risk EG003
Bone Pain	Musculoskeletal and connective tissue disorders	MedDRA Version 13.0	Non-systematic Assessment	EG0000 affected8 at risk EG0010 affected6 at risk EG0021 affected6 at risk EG003
Muscular Weakness	Musculoskeletal and connective tissue disorders	MedDRA Version 13.0	Non-systematic Assessment	EG0002 affected8 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Musculoskeletal Pain	Musculoskeletal and connective tissue disorders	MedDRA Version 13.0	Non-systematic Assessment	EG0000 affected8 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA Version 13.0	Non-systematic Assessment	EG0001 affected8 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Neck Pain	Musculoskeletal and connective tissue disorders	MedDRA Version 13.0	Non-systematic Assessment	EG0001 affected8 at risk EG0011 affected6 at risk EG0020 affected6 at risk EG003
Pain In Extremity	Musculoskeletal and connective tissue disorders	MedDRA Version 13.0	Non-systematic Assessment	EG0000 affected8 at risk EG0012 affected6 at risk EG0021 affected6 at risk EG003
Pain In Jaw	Musculoskeletal and connective tissue disorders	MedDRA Version 13.0	Non-systematic Assessment	EG0000 affected8 at risk EG0010 affected6 at risk EG0021 affected6 at risk EG003
Dysgeusia	Nervous system disorders	MedDRA Version 13.0	Non-systematic Assessment	EG0000 affected8 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Headache	Nervous system disorders	MedDRA Version 13.0	Non-systematic Assessment	EG0001 affected8 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA Version 13.0	Non-systematic Assessment	EG0000 affected8 at risk EG0011 affected6 at risk EG0020 affected6 at risk EG003
Peripheral Sensory Neuropathy	Nervous system disorders	MedDRA Version 13.0	Non-systematic Assessment	EG0000 affected8 at risk EG0011 affected6 at risk EG0020 affected6 at risk EG003
Insomnia	Psychiatric disorders	MedDRA Version 13.0	Non-systematic Assessment	EG0000 affected8 at risk EG0011 affected6 at risk EG0020 affected6 at risk EG003
Bladder Pain	Renal and urinary disorders	MedDRA Version 13.0	Non-systematic Assessment	EG0000 affected8 at risk EG0011 affected6 at risk EG0020 affected6 at risk EG003
Micturition Disorder	Renal and urinary disorders	MedDRA Version 13.0	Non-systematic Assessment	EG0001 affected8 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Urinary Retention	Renal and urinary disorders	MedDRA Version 13.0	Non-systematic Assessment	EG0000 affected8 at risk EG0011 affected6 at risk EG0020 affected6 at risk EG003
Balanitis	Reproductive system and breast disorders	MedDRA Version 13.0	Non-systematic Assessment	EG0000 affected8 at risk EG0010 affected6 at risk EG0021 affected6 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA Version 13.0	Non-systematic Assessment	EG0000 affected8 at risk EG0011 affected6 at risk EG0020 affected6 at risk EG003
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA Version 13.0	Non-systematic Assessment	EG0000 affected8 at risk EG0011 affected6 at risk EG0020 affected6 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDRA Version 13.0	Non-systematic Assessment	EG0000 affected8 at risk EG0010 affected6 at risk EG0022 affected6 at risk EG003
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA Version 13.0	Non-systematic Assessment	EG0000 affected8 at risk EG0011 affected6 at risk EG0020 affected6 at risk EG003
Pruritus Generalised	Skin and subcutaneous tissue disorders	MedDRA Version 13.0	Non-systematic Assessment	EG0001 affected8 at risk EG0011 affected6 at risk EG0020 affected6 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA Version 13.0	Non-systematic Assessment	EG0001 affected8 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Skin Exfoliation	Skin and subcutaneous tissue disorders	MedDRA Version 13.0	Non-systematic Assessment	EG0000 affected8 at risk EG0011 affected6 at risk EG0020 affected6 at risk EG003
Hypertension	Vascular disorders	MedDRA Version 13.0	Non-systematic Assessment	EG0000 affected8 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Hypotension	Vascular disorders	MedDRA Version 13.0	Non-systematic Assessment	EG0000 affected8 at risk EG0011 affected6 at risk EG0021 affected6 at risk EG003
Peripheral Coldness	Vascular disorders	MedDRA Version 13.0	Non-systematic Assessment	EG0000 affected8 at risk EG0011 affected6 at risk EG0020 affected6 at risk EG003

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D011469	Prostatic Diseases
D052801	Male Urogenital Diseases

ID	Title	Description
BG000	EMD 525797 250 mg	Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.
BG001	EMD 525797 500 mg	Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.
BG002	EMD 525797 1000 mg	Subjects were administered with 1000 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.
BG003	EMD 525797 1500 mg	Subjects were administered with 1500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.
BG004	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	EMD 525797 250 mg	Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.	5	8	8	8
EG001	EMD 525797 500 mg	Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.	1	6	6	6
EG002	EMD 525797 1000 mg	Subjects were administered with 1000 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.	4	6	6	6
EG003	EMD 525797 1500 mg	Subjects were administered with 1500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator's discretion.	3	6	6	6