Trial Outcomes & Findings for A Study of EMD525797 in Solid Tumor Patients in Japan (NCT NCT01327313)

Last Updated: 2016-05-13

Results Overview

DLT was defined as any Grade 3 or 4 haematological or non-haematological toxicity occurring at any dose level until the end of Week 4, and suspected to be reasonably related to the investigational medicinal product by the Investigator and/or Sponsor. Toxicities not considered to be DLTs are as follows- Allergic reactions or anaphylaxis; any Grade 3 or 4 out-of-range laboratory values without any clinical correlate, which were reversible within 7 days, unless the Investigator decided this event is clinically significant. For this reason Grade 3 or 4 out-of-range laboratory values must be re-assessed within 7 days. In case the Investigator provides the subject any treatment(s) due to the out-of-range laboratory values, the event was regarded as a DLT.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

27 participants

Primary outcome timeframe

Baseline up to Week 4

Results posted on

2016-05-13

Participant Flow

Participant milestones

Participant milestones
Measure	EMD525797 250 mg 250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	EMD525797 500 mg 500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	EMD525797 1000 mg 1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	EMD525797 1500 mg 1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
Overall Study STARTED	8	6	6	7
Overall Study COMPLETED	8	6	6	7
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of EMD525797 in Solid Tumor Patients in Japan

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	EMD525797 250 mg n=8 Participants 250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	EMD525797 500 mg n=6 Participants 500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	EMD525797 1000 mg n=6 Participants 1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	EMD525797 1500 mg n=7 Participants 1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	Total n=27 Participants Total of all reporting groups
Age, Continuous	53.4 years STANDARD_DEVIATION 11.64 • n=5 Participants	60.5 years STANDARD_DEVIATION 4.42 • n=7 Participants	54.7 years STANDARD_DEVIATION 14.32 • n=5 Participants	57.3 years STANDARD_DEVIATION 10.81 • n=4 Participants	56.3 years STANDARD_DEVIATION 10.69 • n=21 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	4 Participants n=4 Participants	12 Participants n=21 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	15 Participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline up to Week 4

Population: Dose escalation analysis set/DLT analysis set included all subjects who experienced a DLT or subjects who did not experience a DLT and had a relative dose intensity of \>= 75 percent (%) during the DLT observation period.

Outcome measures

Outcome measures
Measure	EMD525797 250 mg n=8 Participants 250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	EMD525797 500 mg n=6 Participants 500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	EMD525797 1000 mg n=6 Participants 1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	EMD525797 1500 mg n=6 Participants 1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
Number of Subjects With Dose-limiting Toxicities (DLTs)	0 subjects	0 subjects	0 subjects	0 subjects

PRIMARY outcome

Timeframe: Pre-dose, hour 1(end of infusion [EOI]), 4, 8, 24, 48, and 96 hours after start of infusion at Week 1

Population: The pharmacokinetic (PK) analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797.

Outcome measures

Outcome measures
Measure	EMD525797 250 mg n=8 Participants 250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	EMD525797 500 mg n=6 Participants 500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	EMD525797 1000 mg n=6 Participants 1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	EMD525797 1500 mg n=7 Participants 1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
Maximum Observed Serum Concentration (Cmax): After Single Dose	73.12 microgram per milliliter (mcg/mL) Geometric Coefficient of Variation 12.1	162.48 microgram per milliliter (mcg/mL) Geometric Coefficient of Variation 15.2	419.26 microgram per milliliter (mcg/mL) Geometric Coefficient of Variation 16.4	683.46 microgram per milliliter (mcg/mL) Geometric Coefficient of Variation 28.0

PRIMARY outcome

Timeframe: Pre-dose, hour 1 (EOI), 4, 8, 24, 48, and 96 hours after start of infusion at Week 5

Population: The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797. Here N (number of subjects analyzed) signifies the total number of subjects evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	EMD525797 250 mg n=6 Participants 250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	EMD525797 500 mg n=6 Participants 500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	EMD525797 1000 mg n=6 Participants 1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	EMD525797 1500 mg n=6 Participants 1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
Maximum Observed Serum Concentration (Cmax) of EMD 525797:After Multiple Dose	89.336 mcg/mL Geometric Coefficient of Variation 6.6	198.728 mcg/mL Geometric Coefficient of Variation 20.1	680.022 mcg/mL Geometric Coefficient of Variation 18.1	1170.73 mcg/mL Geometric Coefficient of Variation 22.2

PRIMARY outcome

Timeframe: Pre-dose, hour 1 (EOI), 4, 8, 24, 48, and 96 hours after start of infusion at Week 1

Population: The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797.

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).

Outcome measures

Outcome measures
Measure	EMD525797 250 mg n=8 Participants 250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	EMD525797 500 mg n=6 Participants 500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	EMD525797 1000 mg n=6 Participants 1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	EMD525797 1500 mg n=7 Participants 1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
Area Under the Curve From Time Zero to Last Quantifiable Concentration(AUC0-t) of EMD 525797: After Single Dose	7942.6 hour*mcg/mL Geometric Coefficient of Variation 19.6	21562.3 hour*mcg/mL Geometric Coefficient of Variation 14.0	67545.6 hour*mcg/mL Geometric Coefficient of Variation 18.9	95369.6 hour*mcg/mL Geometric Coefficient of Variation 40.9

PRIMARY outcome

Timeframe: Pre-dose, hour 1 (EOI), 4, 8, 24, 48, and 96 hours after start of infusion at Week 5

Area under the serum concentration-time curve from time zero to the last sampling time at which the concentration is at or above LLQ.

Outcome measures

Outcome measures
Measure	EMD525797 250 mg n=6 Participants 250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	EMD525797 500 mg n=6 Participants 500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	EMD525797 1000 mg n=6 Participants 1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	EMD525797 1500 mg n=6 Participants 1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
Area Under the Curve From Time Zero to Last Quantifiable Concentration(AUC0-t) of EMD 525797: After Multiple Dose	10674.2 hour*mcg/mL Geometric Coefficient of Variation 30.2	37344.9 hour*mcg/mL Geometric Coefficient of Variation 28.2	159979.5 hour*mcg/mL Geometric Coefficient of Variation 29.5	242989.3 hour*mcg/mL Geometric Coefficient of Variation 35.7

PRIMARY outcome

Timeframe: Pre-dose, hour 1 (EOI), 4, 8, 24, 48, and 96 hours after start of infusion at Week 1

Population: The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797.

Total body clearance of drug in serum was calculated: as CL= Dose divided by Area under the serum concentration-time curve from time zero to infinity (AUC0-inf).

Outcome measures

Outcome measures
Measure	EMD525797 250 mg n=8 Participants 250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	EMD525797 500 mg n=6 Participants 500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	EMD525797 1000 mg n=6 Participants 1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	EMD525797 1500 mg n=7 Participants 1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
Total Body Clearance (CL) of EMD 525797: After Single Dose	0.0294 liter per hour Geometric Coefficient of Variation 24.5	0.0188 liter per hour Geometric Coefficient of Variation 29.9	0.0083 liter per hour Geometric Coefficient of Variation 23.0	0.0089 liter per hour Geometric Coefficient of Variation 52.9

PRIMARY outcome

Timeframe: Pre-dose, hour 1 (EOI), 4, 8, 24, 48, and 96 hours after start of infusion at Week 5

Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. CL of drug in serum was calculated as : CL= Dose/ AUC0-inf. Area under the serum concentration-time curve from time zero to infinity (AUC0-inf), 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 the elimination rate constant.

Outcome measures

Outcome measures
Measure	EMD525797 250 mg n=6 Participants 250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	EMD525797 500 mg n=6 Participants 500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	EMD525797 1000 mg n=6 Participants 1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	EMD525797 1500 mg n=6 Participants 1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
Total Body Clearance at Steady State (CLss) of EMD 525797	0.0224 liter per hour Geometric Coefficient of Variation 26.4	0.0154 liter per hour Geometric Coefficient of Variation 26.9	0.0075 liter per hour Geometric Coefficient of Variation 19.1	0.0078 liter per hour Geometric Coefficient of Variation 25.1

PRIMARY outcome

Timeframe: Pre-dose, hour 1 (EOI), 4, 8, 24, 48, and 96 hours after start of infusion at Week 1

Population: The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797.

Apparent volume of distribution during the terminal phase, calculated as Vz = Dose/AUC0-inf multiplied by elimination rate constant \[λz\]) following single dose. Area under the serum concentration-time curve from time zero to infinity, calculated (AUC0-inf) 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 the elimination rate constant. And the elimination rate constant obtained from linear regression of the terminal phase of the log transformed concentration-time data. A minimum of three points is required to calculate λz.

Outcome measures

Outcome measures
Measure	EMD525797 250 mg n=8 Participants 250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	EMD525797 500 mg n=6 Participants 500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	EMD525797 1000 mg n=6 Participants 1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	EMD525797 1500 mg n=7 Participants 1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
Apparent Volume of Distribution (Vz): After Single Dose	3.285 liter Geometric Coefficient of Variation 20.5	3.284 liter Geometric Coefficient of Variation 37.8	3.506 liter Geometric Coefficient of Variation 23.7	3.268 liter Geometric Coefficient of Variation 17.3

PRIMARY outcome

Timeframe: Pre-dose, hour 1 (EOI), 4, 8, 24, 48, and 96 hours after start of infusion at Week 5

The observed serum concentration immediately before next dosing determined directly from the serum concentration-time profile of each subject (= trough concentration).

Outcome measures

Outcome measures
Measure	EMD525797 250 mg n=6 Participants 250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	EMD525797 500 mg n=6 Participants 500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	EMD525797 1000 mg n=6 Participants 1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	EMD525797 1500 mg n=6 Participants 1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
Pharmacokinetics of EMD 525797 - Trough Values	5.73 mcg/mL Geometric Coefficient of Variation 150.7	44.28 mcg/mL Geometric Coefficient of Variation 40.1	200.05 mcg/mL Geometric Coefficient of Variation 30.3	286.11 mcg/mL Geometric Coefficient of Variation 30.5

PRIMARY outcome

Timeframe: Pre-dose, hour 1 (EOI), 4, 8, 24, 48, and 96 hours after start of infusion at Week 5

Apparent volume of distribution during the terminal phase, calculated as Vz = Dose/(Area under the serum concentration-time curve within one complete dosing interval \[AUCtau\]\* λz) following multiple dose.

Outcome measures

Outcome measures
Measure	EMD525797 250 mg n=6 Participants 250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	EMD525797 500 mg n=6 Participants 500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	EMD525797 1000 mg n=6 Participants 1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	EMD525797 1500 mg n=6 Participants 1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
Apparent Volume of Distribution: After Multiple Dose	3.505 liter Geometric Coefficient of Variation 18.2	3.775 liter Geometric Coefficient of Variation 22.0	4.224 liter Geometric Coefficient of Variation 21.5	4.565 liter Geometric Coefficient of Variation 40.0

SECONDARY outcome

Timeframe: Baseline up to Week 36

Population: Full analysis set included all subjects who received at least one (non-zero) administration of the trial medication.

Overall tumor response was defined as the presence of at least one confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0. Complete response was defined as the disappearance of all target and non-target lesions and normalization of serum levels of tumor markers. PR is at least a 30 percent (%) decrease in the sum of the longest diameter (LD) of target lesions, taking as a reference the baseline sum LD.

Outcome measures

Outcome measures
Measure	EMD525797 250 mg n=8 Participants 250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	EMD525797 500 mg n=6 Participants 500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	EMD525797 1000 mg n=6 Participants 1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	EMD525797 1500 mg n=7 Participants 1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
Number of Subjects With Overall Tumor Response	0 subjects	0 subjects	0 subjects	0 subjects

SECONDARY outcome

Timeframe: Baseline up to Week 36

Population: Full analysis set included all subjects who received at least one (non-zero) administration of the trial medication.

Clinical benefit was defined as presence of at least one confirmed CR, PR, or stable disease (SD) lasting at least 12 weeks according to RECIST v1.0. Per RECIST v1.0: CR was defined as disappearance of all target and non-target lesions and normalization of serum levels of tumor markers . PR was defined as \>=30% decrease in sum of longest diameters of target lesions taking as reference baseline sum longest diameters associated to non-progressive disease response for non-target lesions. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease taking as reference smallest sum of longest dimensions since treatment started associated to non-progressive disease response for non-target lesions.

Outcome measures

Outcome measures
Measure	EMD525797 250 mg n=8 Participants 250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	EMD525797 500 mg n=6 Participants 500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	EMD525797 1000 mg n=6 Participants 1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	EMD525797 1500 mg n=7 Participants 1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
Number of Subjects With Clinical Benefit	0 subjects	0 subjects	0 subjects	0 subjects

SECONDARY outcome

Timeframe: From first dosing date until disease progression or death, maximum up to Week 36

Population: Full analysis set included all subjects who received at least one (non-zero) administration of the trial medication.

PFS time was defined as the time (in months) from the first dosing date to the date of first documentation of disease progression as reported and documented by the Investigator (i.e. radiological progression per RECIST version 1.0) or death for any cause within 12 weeks after last tumor assessment. Subjects without event are censored on the date of last tumor assessment.

Outcome measures

Outcome measures
Measure	EMD525797 250 mg n=8 Participants 250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	EMD525797 500 mg n=6 Participants 500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	EMD525797 1000 mg n=6 Participants 1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	EMD525797 1500 mg n=7 Participants 1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
Progression-free Survival (PFS)	1.18 months Interval 0.8 to 1.2	1.23 months Interval 1.2 to 2.1	1.31 months Interval 1.2 to 5.5	1.25 months Interval 0.4 to 2.8

SECONDARY outcome

Timeframe: Pre-dose, end of infusion (EOI), 4, 8, 24, 48, and 96 hours after start of infusion at Week 1

Population: The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797.

Outcome measures

Outcome measures
Measure	EMD525797 250 mg n=8 Participants 250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	EMD525797 500 mg n=6 Participants 500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	EMD525797 1000 mg n=6 Participants 1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	EMD525797 1500 mg n=7 Participants 1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
Apparent Terminal Half Life (t1/2): After Single Dose	83.95 hour Interval 52.7 to 124.1	114.45 hour Interval 45.6 to 272.4	298.99 hour Interval 205.7 to 411.7	240.76 hour Interval 150.5 to 612.3

SECONDARY outcome

Timeframe: Pre-dose, EOI, 4, 8, 24, 48, and 96 hours after start of infusion at Week 5

Outcome measures

Outcome measures
Measure	EMD525797 250 mg n=6 Participants 250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	EMD525797 500 mg n=6 Participants 500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	EMD525797 1000 mg n=6 Participants 1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	EMD525797 1500 mg n=6 Participants 1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
Apparent Terminal Half Life (t1/2): After Multiple Dose	119.58 hour Interval 56.2 to 145.9	195.75 hour Interval 86.9 to 221.7	345.92 hour Interval 294.0 to 751.1	448.45 hour Interval 224.3 to 760.5

SECONDARY outcome

Timeframe: Pre-dose, end of infusion (EOI), 4, 8, 24, 48, and 96 hours after start of infusion at Week 1

Population: The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797.

Outcome measures

Outcome measures
Measure	EMD525797 250 mg n=8 Participants 250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	EMD525797 500 mg n=6 Participants 500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	EMD525797 1000 mg n=6 Participants 1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	EMD525797 1500 mg n=7 Participants 1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
Time to Maximum Observed Serum Concentration (Tmax): After Single Dose	1.033 hour Interval 1.02 to 24.03	1.033 hour Interval 1.0 to 4.0	3.967 hour Interval 1.02 to 7.95	1.067 hour Interval 1.03 to 24.05

SECONDARY outcome

Timeframe: Pre-dose, EOI, 4, 8, 24, 48, and 96 hours after start of infusion at Week 5

Outcome measures

Outcome measures
Measure	EMD525797 250 mg n=6 Participants 250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	EMD525797 500 mg n=6 Participants 500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	EMD525797 1000 mg n=6 Participants 1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	EMD525797 1500 mg n=6 Participants 1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
Time to Maximum Observed Serum Concentration (Tmax): After Multiple Dose	1.042 hour Interval 1.0 to 47.97	3.00 hour Interval 1.02 to 24.12	1.025 hour Interval 1.0 to 4.02	4.000 hour Interval 1.07 to 23.95

SECONDARY outcome

Timeframe: Pre-dose, end of infusion (EOI), 4, 8, 24, 48, and 96 hours after start of infusion at Week 1

Population: The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797.

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

Outcome measures

Outcome measures
Measure	EMD525797 250 mg n=8 Participants 250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	EMD525797 500 mg n=6 Participants 500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	EMD525797 1000 mg n=6 Participants 1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	EMD525797 1500 mg n=7 Participants 1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
Elimination Rate Constant (λz): After Single Dose	0.00895 per hour Geometric Coefficient of Variation 31.5	0.00573 per hour Geometric Coefficient of Variation 66.7	0.00237 per hour Geometric Coefficient of Variation 25.6	0.00272 per hour Geometric Coefficient of Variation 49.6

SECONDARY outcome

Timeframe: Pre-dose, EOI, 4, 8, 24, 48, and 96 hours after start of infusion at Week 5

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

Outcome measures

Outcome measures
Measure	EMD525797 250 mg n=6 Participants 250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	EMD525797 500 mg n=6 Participants 500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	EMD525797 1000 mg n=6 Participants 1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	EMD525797 1500 mg n=6 Participants 1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
Elimination Rate Constant ( λ z): After Multiple Dose	0.00639 per hour Geometric Coefficient of Variation 35.5	0.00407 per hour Geometric Coefficient of Variation 36.7	0.00178 per hour Geometric Coefficient of Variation 35.2	0.00170 per hour Geometric Coefficient of Variation 53.3

SECONDARY outcome

Timeframe: Pre-dose, EOI, 4, 8, 24, 48, and 96 hours after start of infusion at Week 5

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

Outcome measures

Outcome measures
Measure	EMD525797 250 mg n=6 Participants 250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	EMD525797 500 mg n=6 Participants 500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	EMD525797 1000 mg n=6 Participants 1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	EMD525797 1500 mg n=6 Participants 1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
Minimum Observed Serum Concentration (Cmin) After Multiple Doses	5.64 mcg/mL Geometric Coefficient of Variation 154.6	44.22 mcg/mL Geometric Coefficient of Variation 40.2	200.5 mcg/mL Geometric Coefficient of Variation 30.3	286.11 mcg/mL Geometric Coefficient of Variation 30.5

SECONDARY outcome

Timeframe: Pre-dose, EOI, 4, 8, 24, 48, and 96 hours after start of infusion at Week 5

The observed serum concentration immediately before next dosing determined directly from the serum concentration-time profile of each subject (= trough concentration)

Outcome measures

Outcome measures
Measure	EMD525797 250 mg n=6 Participants 250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	EMD525797 500 mg n=6 Participants 500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	EMD525797 1000 mg n=6 Participants 1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	EMD525797 1500 mg n=6 Participants 1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
Observed Serum Concentration Immediately Before Next Dosing (Cpre)	5.73 mcg/mL Geometric Coefficient of Variation 150.7	44.28 mcg/mL Geometric Coefficient of Variation 40.1	200.05 mcg/mL Geometric Coefficient of Variation 30.3	286.11 mcg/mL Geometric Coefficient of Variation 30.5

SECONDARY outcome

Timeframe: Pre-dose, EOI, 4, 8, 24, 48, and 96 hours after start of infusion at Week 5

The Cav was calculated by dividing the area under the serum concentration-time curve within one complete dosing interval (AUCtau) by the dosing interval (2 weeks or 336 hoursi.e. Cav =AUCtau/tau).

Outcome measures

Outcome measures
Measure	EMD525797 250 mg n=6 Participants 250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	EMD525797 500 mg n=6 Participants 500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	EMD525797 1000 mg n=6 Participants 1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	EMD525797 1500 mg n=6 Participants 1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
Average Serum Concentration at Steady State (Cav)	33.23 mcg/mL Geometric Coefficient of Variation 26.4	96.91 mcg/mL Geometric Coefficient of Variation 26.9	395.47 mcg/mL Geometric Coefficient of Variation 19.1	574.09 mcg/mL Geometric Coefficient of Variation 25.1

SECONDARY outcome

Timeframe: Pre-dose, end of infusion (EOI), 4, 8, 24, 48, and 96 hours after start of infusion at Week 1

Population: The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797.

Outcome measures

Outcome measures
Measure	EMD525797 250 mg n=8 Participants 250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	EMD525797 500 mg n=6 Participants 500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	EMD525797 1000 mg n=6 Participants 1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	EMD525797 1500 mg n=7 Participants 1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
Area Under the Serum Concentration-time Curve Within One Complete Dosing Interval( AUCtau): After Single Dose	7970.1 hour*mcg/mL Geometric Coefficient of Variation 20.3	21563.6 hour*mcg/mL Geometric Coefficient of Variation 14.0	67555.4 hour*mcg/mL Geometric Coefficient of Variation 19.0	100861.0 hour*mcg/mL Geometric Coefficient of Variation 26.5

SECONDARY outcome

Timeframe: Pre-dose, EOI, 4, 8, 24, 48, and 96 hours after start of infusion at Week 5

Outcome measures

Outcome measures
Measure	EMD525797 250 mg n=6 Participants 250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	EMD525797 500 mg n=6 Participants 500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	EMD525797 1000 mg n=6 Participants 1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	EMD525797 1500 mg n=6 Participants 1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
Area Under the Serum Concentration-time Curve Within One Complete Dosing Interval( AUCtau): After Multiple Dose	11164.0 hour*mcg/mL Geometric Coefficient of Variation 26.4	32561.0 hour*mcg/mL Geometric Coefficient of Variation 26.9	132877.8 hour*mcg/mL Geometric Coefficient of Variation 19.1	192894.5 hour*mcg/mL Geometric Coefficient of Variation 25.1

SECONDARY outcome

Timeframe: Pre-dose, EOI, 4, 8, 24, 48, and 96 hours after start of infusion at Week 5

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 blood concentration of a drug. Steady state volume of distribution (Vss) was the apparent volume of distribution at steady-state.

Outcome measures

Outcome measures
Measure	EMD525797 250 mg n=6 Participants 250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	EMD525797 500 mg n=6 Participants 500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	EMD525797 1000 mg n=6 Participants 1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	EMD525797 1500 mg n=6 Participants 1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
Volume of Distribution at Steady State (Vss)	3.584 liter Geometric Coefficient of Variation 9.6	4.004 liter Geometric Coefficient of Variation 17.2	4.131 liter Geometric Coefficient of Variation 21.6	4.392 liter Geometric Coefficient of Variation 38.9

SECONDARY outcome

Timeframe: Pre-dose, end of infusion (EOI), 4, 8, 24, 48, and 96 hours after start of infusion at Week 1

Population: The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797.

MRT0-inf of drug in the body was calculated by dividing the area under the first moment curve from time zero to infinity with area under the first moment curve from time zero to infinity minus half of infusion of duration (MRT0-inf = AUMC0-inf/AUMC0-inf - T/2).

Outcome measures

Outcome measures
Measure	EMD525797 250 mg n=8 Participants 250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	EMD525797 500 mg n=6 Participants 500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	EMD525797 1000 mg n=6 Participants 1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	EMD525797 1500 mg n=7 Participants 1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
Mean Residency Time (MRT0-inf)	118.46 hour Geometric Coefficient of Variation 25.0	187.29 hour Geometric Coefficient of Variation 48.7	408.34 hour Geometric Coefficient of Variation 23.3	357.21 hour Geometric Coefficient of Variation 48.8

SECONDARY outcome

Timeframe: Pre-dose, EOI, 4, 8, 24, 48, and 96 hours after start of infusion at Week 5

MRTss = (AUMCtau + tau(AUCinf - AUCtau))/ AUCtau) - T/2, where AUMCtau was the area under the first moment curve within one complete dosing interval and T was the infusion duration. 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 the elimination rate constant.

Outcome measures

Outcome measures
Measure	EMD525797 250 mg n=6 Participants 250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	EMD525797 500 mg n=6 Participants 500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	EMD525797 1000 mg n=6 Participants 1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	EMD525797 1500 mg n=6 Participants 1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
Mean Residence Time at Steady State (MRTss)	160.05 hour Geometric Coefficient of Variation 28.0	260.73 hour Geometric Coefficient of Variation 29.5	548.88 hour Geometric Coefficient of Variation 35.5	564.86 hour Geometric Coefficient of Variation 53.1

SECONDARY outcome

Timeframe: Pre-dose, EOI, 4, 8, 24, 48, and 96 hours after start of infusion at Week 5

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

Outcome measures

Outcome measures
Measure	EMD525797 250 mg n=6 Participants 250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	EMD525797 500 mg n=6 Participants 500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	EMD525797 1000 mg n=6 Participants 1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	EMD525797 1500 mg n=6 Participants 1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
Percentage Peak-Trough Fluctuation (PTF)	243.64 percentage fluctuation Geometric Coefficient of Variation 33.4	157.93 percentage fluctuation Geometric Coefficient of Variation 17.0	118.69 percentage fluctuation Geometric Coefficient of Variation 31.8	153.22 percentage fluctuation Geometric Coefficient of Variation 20.7

SECONDARY outcome

Timeframe: Pre-dose, end of infusion (EOI), 4, 8, 24, 48, and 96 hours after start of infusion at Week 1 and Week 5

Accumulation ratio for AUC, calculated as area under the serum concentration-time curve within one complete dosing interval at 3rd infusion divided by area under the serum concentration-time curve within one complete dosing interval at 1st infusion.

Outcome measures

Outcome measures
Measure	EMD525797 250 mg n=6 Participants 250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	EMD525797 500 mg n=6 Participants 500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	EMD525797 1000 mg n=6 Participants 1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	EMD525797 1500 mg n=6 Participants 1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
Accumulation Ratio (Rac)	1.371 ratio Geometric Coefficient of Variation 23.5	1.510 ratio Geometric Coefficient of Variation 18.4	1.967 ratio Geometric Coefficient of Variation 13.0	1.762 ratio Geometric Coefficient of Variation 12.0

Adverse Events

EMD525797 250 mg

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

EMD525797 500 mg

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

EMD525797 1000 mg

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

EMD525797 1500 mg

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	EMD525797 250 mg n=8 participants at risk 250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	EMD525797 500 mg n=6 participants at risk 500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	EMD525797 1000 mg n=6 participants at risk 1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.	EMD525797 1500 mg n=7 participants at risk 1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
Gastrointestinal disorders Colitis	0.00% 0/8 • First dose of the study drug up to 31+/-3 days after the last administration of EMD 525797, assessed upto maximum of 22 months. The safety analysis set included all subjects who received at least one (non-zero) administration of the trial medication.	0.00% 0/6 • First dose of the study drug up to 31+/-3 days after the last administration of EMD 525797, assessed upto maximum of 22 months. The safety analysis set included all subjects who received at least one (non-zero) administration of the trial medication.	16.7% 1/6 • Number of events 1 • First dose of the study drug up to 31+/-3 days after the last administration of EMD 525797, assessed upto maximum of 22 months. The safety analysis set included all subjects who received at least one (non-zero) administration of the trial medication.	0.00% 0/7 • First dose of the study drug up to 31+/-3 days after the last administration of EMD 525797, assessed upto maximum of 22 months. The safety analysis set included all subjects who received at least one (non-zero) administration of the trial medication.
Infections and infestations Pneumonia	0.00% 0/8 • First dose of the study drug up to 31+/-3 days after the last administration of EMD 525797, assessed upto maximum of 22 months. The safety analysis set included all subjects who received at least one (non-zero) administration of the trial medication.	0.00% 0/6 • First dose of the study drug up to 31+/-3 days after the last administration of EMD 525797, assessed upto maximum of 22 months. The safety analysis set included all subjects who received at least one (non-zero) administration of the trial medication.	0.00% 0/6 • First dose of the study drug up to 31+/-3 days after the last administration of EMD 525797, assessed upto maximum of 22 months. The safety analysis set included all subjects who received at least one (non-zero) administration of the trial medication.	14.3% 1/7 • Number of events 1 • First dose of the study drug up to 31+/-3 days after the last administration of EMD 525797, assessed upto maximum of 22 months. The safety analysis set included all subjects who received at least one (non-zero) administration of the trial medication.
Metabolism and nutrition disorders Decreased Appetite	0.00% 0/8 • First dose of the study drug up to 31+/-3 days after the last administration of EMD 525797, assessed upto maximum of 22 months. The safety analysis set included all subjects who received at least one (non-zero) administration of the trial medication.	16.7% 1/6 • Number of events 1 • First dose of the study drug up to 31+/-3 days after the last administration of EMD 525797, assessed upto maximum of 22 months. The safety analysis set included all subjects who received at least one (non-zero) administration of the trial medication.	0.00% 0/6 • First dose of the study drug up to 31+/-3 days after the last administration of EMD 525797, assessed upto maximum of 22 months. The safety analysis set included all subjects who received at least one (non-zero) administration of the trial medication.	0.00% 0/7 • First dose of the study drug up to 31+/-3 days after the last administration of EMD 525797, assessed upto maximum of 22 months. The safety analysis set included all subjects who received at least one (non-zero) administration of the trial medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer Pain	0.00% 0/8 • First dose of the study drug up to 31+/-3 days after the last administration of EMD 525797, assessed upto maximum of 22 months. The safety analysis set included all subjects who received at least one (non-zero) administration of the trial medication.	16.7% 1/6 • Number of events 1 • First dose of the study drug up to 31+/-3 days after the last administration of EMD 525797, assessed upto maximum of 22 months. The safety analysis set included all subjects who received at least one (non-zero) administration of the trial medication.	0.00% 0/6 • First dose of the study drug up to 31+/-3 days after the last administration of EMD 525797, assessed upto maximum of 22 months. The safety analysis set included all subjects who received at least one (non-zero) administration of the trial medication.	0.00% 0/7 • First dose of the study drug up to 31+/-3 days after the last administration of EMD 525797, assessed upto maximum of 22 months. The safety analysis set included all subjects who received at least one (non-zero) administration of the trial medication.
Respiratory, thoracic and mediastinal disorders Atelectasis	12.5% 1/8 • Number of events 1 • First dose of the study drug up to 31+/-3 days after the last administration of EMD 525797, assessed upto maximum of 22 months. The safety analysis set included all subjects who received at least one (non-zero) administration of the trial medication.	0.00% 0/6 • First dose of the study drug up to 31+/-3 days after the last administration of EMD 525797, assessed upto maximum of 22 months. The safety analysis set included all subjects who received at least one (non-zero) administration of the trial medication.	0.00% 0/6 • First dose of the study drug up to 31+/-3 days after the last administration of EMD 525797, assessed upto maximum of 22 months. The safety analysis set included all subjects who received at least one (non-zero) administration of the trial medication.	0.00% 0/7 • First dose of the study drug up to 31+/-3 days after the last administration of EMD 525797, assessed upto maximum of 22 months. The safety analysis set included all subjects who received at least one (non-zero) administration of the trial medication.

Other adverse events

Additional Information

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Principal investigator is a sponsor employee
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