A Phase 1 interventional study of EMD 525797 in Prostate Cancer and Bone Metastases, sponsored by Merck KGaA, Darmstadt, Germany. Completed at 4 sites in 2 countries. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-08-02.
Sponsored by Merck KGaA, Darmstadt, Germany · Phase 1, Interventional, and Treatment
This study is intended to test an experimental new drug called, EMD 525797 (Study Drug). This drug is not yet approved for sale and has only been tested in a small number of people to date (prior to this study starting another research study was carried out involving 37 healthy volunteers receiving the Study Drug). Until more is known about this Study Drug, it can only be used in research studies.
This research study is planned to answer important questions about how the Study Drug is tolerated and how it may work in patients with prostate cancer with bone metastases.
This is a small study which is expected to include 24 patients, and will be conducted in approximately 3 hospitals in Germany and 1 hospital in Brussels, Belgium. The study will last until the last patient has had their last study visit which is expected to be about 18 months in total.
6,484 studies on the registry are indexed under Prostatic Neoplasms; 1,415 are open to participants now.
This study's enrollment of 26 is below the median of 58 across 4,908 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Merck KGaA, Darmstadt, Germany is the lead sponsor of 275 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Biological: EMD 525797
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.
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.
Time frame: 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.
Time frame: Baseline up to 534 days
Observed Maximum Serum Concentration (Cmax) of EMD 525797 After First Infusion
Time frame: 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
Time frame: pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 5
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.
Time frame: pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 1
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.
Time frame: pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 1
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.
Time frame: pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 1
Trough Serum Concentration (Ctrough) Of EMD 525797 at Week 1
Ctrough is the concentration prior to study drug administration.
Time frame: pre-dose at Week 1
Trough Serum Concentration (Ctrough) Of EMD 525797 at Week 3
Ctrough is the concentration prior to study drug administration.
Time frame: pre-dose at Week 3
Trough Serum Concentration (Ctrough) Of EMD 525797 at Week 5
Ctrough is the concentration prior to study drug administration.
Time frame: pre-dose at Week 5
Time to Reach Observed Serum Concentration (Tmax) After First Infusion
Time frame: 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
Time frame: pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 5
Number of Subjects With Positive Anti-EMD 525797 Antibodies
Time frame: Week 1, 3, 5, 8, 9
Serum Levels of Interleukin 6 (IL-6) and Interleukin 8 (IL-8)
Time frame: Week 1 up to a maximum of 56 days
C-Reactive Protein Levels
Time frame: Week 1 up to a maximum of 56 days
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.
Time frame: pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 1
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.
Time frame: pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 1
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.
Time frame: pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 5
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).
Time frame: pre-dose, end of infusion, 4, 8, 24, 48, 96, 168, 336 hours post third infusion at Week 5
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).
Time frame: pre-dose, end of infusion, 4, 8, 24, 48, 96 and 168 hours post-infusion at Week 1
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).
Time frame: pre-dose, end of infusion, 4, 8, 24, 48, 96,168, 336 hours post third infusion at Week 5
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.
Time frame: pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 1
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
Time frame: pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 5
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.
Time frame: pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 1
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.
Time frame: pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 5
Accumulation Ratio Of Cmax (R_Cmax)
Accumulation ratio for Cmax was calculated as Cmax, after third dose/Cmax, after first dose.
Time frame: pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 1 and Week 5
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.
Time frame: 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
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.
Time frame: Week 6, Week 19, Overall (Baseline Up to 394 days)
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).
Time frame: Baseline up to 394 days
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.
Time frame: Baseline up to disease progression up to a maximum of 13.1 months
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.
Time frame: Baseline up to 394 days
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.
Time frame: Baseline up to 394 days
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.
Time frame: 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)
Maximum Percent Change From Baseline in Prostate Specific Antigen (PSA) Level
Maximum percent change from Baseline in PSA Level during the study was reported.
Time frame: Baseline up to 394 days
Minimum Percent Change From Baseline in PSA Level
Minimum percent change from Baseline in PSA Level during the study was reported.
Time frame: Baseline up to 394 days
First/last subject (informed consent): 14 Oct 2008/21 May 2010. Last subject completed: 03 March 2011.
| Milestone | EMD 525797 250 mg | EMD 525797 500 mg | EMD 525797 1000 mg | EMD 525797 1500 mg |
|---|---|---|---|---|
| Started | 8 | 6 | 6 | 6 |
| Completed | 8 | 6 | 6 | 6 |
| Not completed | 0 | 0 | 0 | 0 |
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.
| subjects | EMD 525797 250 mg | EMD 525797 500 mg | EMD 525797 1000 mg | EMD 525797 1500 mg |
|---|---|---|---|---|
| Number of Subjects With Dose Limiting Toxicity (DLT) | 0 | 0 | 0 | 0 |
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.
| Subjects | EMD 525797 250 mg | EMD 525797 500 mg | EMD 525797 1000 mg | EMD 525797 1500 mg |
|---|---|---|---|---|
| TEAEs | 8 | 6 | 6 | 6 |
| Serious TEAEs | 5 | 1 | 4 | 3 |
| Related TEAEs | 2 | 4 | 2 | 3 |
| microgram per milliliter (mcg/mL) | EMD 525797 250 mg | EMD 525797 500 mg | EMD 525797 1000 mg | EMD 525797 1500 mg |
|---|---|---|---|---|
| Observed Maximum Serum Concentration (Cmax) of EMD 525797 After First Infusion | 52.9 ± 15.3 | 115.5 ± 20.1 | 298.0 ± 10.8 | 368.9 ± 26.7 |
| mcg/mL | EMD 525797 250 mg | EMD 525797 500 mg | EMD 525797 1000 mg | EMD 525797 1500 mg |
|---|---|---|---|---|
| Observed Maximum Serum Concentration (Cmax) of EMD 525797 After Third Infusion | 55.7 ± 23.8 | 130.3 ± 17.0 | 371.8 ± 17.8 | 485.7 ± 25.0 |
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.
| h*mcg/mL | EMD 525797 250 mg | EMD 525797 500 mg | EMD 525797 1000 mg | EMD 525797 1500 mg |
|---|---|---|---|---|
| Area Under the Serum Concentration-time Curve From Time Zero to the Last Sampling Time (AUC0-t) After First Infusion | 3583 ± 33 | 15609 ± 16 | 40080 ± 16 | 50891 ± 25 |
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.
| L/h | EMD 525797 250 mg | EMD 525797 500 mg | EMD 525797 1000 mg | EMD 525797 1500 mg |
|---|---|---|---|---|
| Total Body Clearance of Drug From Serum (CL) After First Infusion | 0.060 ± 38.399 | 0.027 ± 25.827 | 0.019 ± 21.791 | 0.020 ± 28.933 |
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.
| Liters | EMD 525797 250 mg | EMD 525797 500 mg | EMD 525797 1000 mg | EMD 525797 1500 mg |
|---|---|---|---|---|
| Apparent Volume of Distribution During Terminal Phase (Vz) of EMD 525797 After First Infusion | 5.06 ± 17.49 | 4.64 ± 7.83 | 4.35 ± 34.54 | 6.16 ± 24.13 |
Ctrough is the concentration prior to study drug administration.
| mcg/mL | EMD 525797 250 mg | EMD 525797 500 mg | EMD 525797 1000 mg | EMD 525797 1500 mg |
|---|---|---|---|---|
| Trough Serum Concentration (Ctrough) Of EMD 525797 at Week 1 | 0.00 ± 0.00 | 0.00 ± 0.00 | 0.00 ± 0.00 | 0.00 ± 0.00 |
Ctrough is the concentration prior to study drug administration.
| mcg/mL | EMD 525797 250 mg | EMD 525797 500 mg | EMD 525797 1000 mg | EMD 525797 1500 mg |
|---|---|---|---|---|
| Trough Serum Concentration (Ctrough) Of EMD 525797 at Week 3 | 0.43 ± 1.05 | 15.17 ± 6.97 | 51.16 ± 23.46 | 81.22 ± 26.72 |
Ctrough is the concentration prior to study drug administration.
| mcg/mL | EMD 525797 250 mg | EMD 525797 500 mg | EMD 525797 1000 mg | EMD 525797 1500 mg |
|---|---|---|---|---|
| Trough Serum Concentration (Ctrough) Of EMD 525797 at Week 5 | 2.70 ± 4.05 | 27.97 ± 12.33 | 105.77 ± 25.22 | 150.74 ± 47.37 |
| hours | EMD 525797 250 mg | EMD 525797 500 mg | EMD 525797 1000 mg | EMD 525797 1500 mg |
|---|---|---|---|---|
| Time to Reach Observed Serum Concentration (Tmax) After First Infusion | 1.0 (1.0 to 5.0) | 8 (1 to 24) | 2.0 (1.0 to 4.0) | 2.0 (1.0 to 5.0) |
| hours | EMD 525797 250 mg | EMD 525797 500 mg | EMD 525797 1000 mg | EMD 525797 1500 mg |
|---|---|---|---|---|
| Time to Reach Observed Serum Concentration (Tmax) After Third Infusion | 1 (1 to 5) | 3 (1 to 5) | 1 (1 to 4) | 1 (1 to 8) |
| Subjects | EMD 525797 250 mg | EMD 525797 500 mg | EMD 525797 1000 mg | EMD 525797 1500 mg |
|---|---|---|---|---|
| Week 1 | 0 | 0 | 0 | 0 |
| Week 3 | 4 | 0 | 0 | 0 |
| Week 5 | 1 | 0 | 0 | 0 |
| Week 8 | 1 | 0 | 0 | 0 |
| Week 9 | 1 | 0 | 0 | 0 |
No measurements were reported for this outcome.
No measurements were reported for this outcome.
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.
| hours | EMD 525797 250 mg | EMD 525797 500 mg | EMD 525797 1000 mg | EMD 525797 1500 mg |
|---|---|---|---|---|
| Apparent Terminal Half-life (t1/2) of EMD 525797 After First Infusion | 60.3 (31.3 to 88.7) | 109.5 (92.0 to 186.8) | 184.5 (66.3 to 233.1) | 222.1 (174.7 to 257.6) |
Elimination rate constant obtained from linear regression of the terminal phase of the log transformed concentration-time data.
| 1/h | EMD 525797 250 mg | EMD 525797 500 mg | EMD 525797 1000 mg | EMD 525797 1500 mg |
|---|---|---|---|---|
| Elimination Rate Constant (λz) of EMD 525797 After First Infusion | 0.0119 ± 34.2179 | 0.0059 ± 28.8297 | 0.0043 ± 47.9226 | 0.0032 ± 16.6282 |
Observed minimum serum concentration determined directly from the serum concentration-time profile of each subject.
| mcg/mL | EMD 525797 250 mg | EMD 525797 500 mg | EMD 525797 1000 mg | EMD 525797 1500 mg |
|---|---|---|---|---|
| Observed Minimum Serum Concentration (Cmin) of EMD 525797 After Third Infusion | 2.7 ± 4.1 | 28.0 ± 12.3 | 102.8 ± 28.2 | 150.7 ± 47.4 |
The average serum concentration at steady state, calculated as Cav = AUCtau/tau, where tau is the dosing interval (336 hours).
| mcg/mL | EMD 525797 250 mg | EMD 525797 500 mg | EMD 525797 1000 mg | EMD 525797 1500 mg |
|---|---|---|---|---|
| Average Serum Concentration at Steady State (Cav) of EMD 525797 After Third Infusion | 16.4 ± 59.6 | 57.1 ± 41.9 | 187.2 ± 28.2 | 178.5 ± 41.3 |
Area under the concentration-time curve from time zero up to time Tau, where Tau is the dosing interval (168 hours).
| h*mcg/mL | EMD 525797 250 mg | EMD 525797 500 mg | EMD 525797 1000 mg | EMD 525797 1500 mg |
|---|---|---|---|---|
| Area Under the Serum Concentration-time Curve Within One Complete Dosing Interval (AUCtau) of EMD 525797 After First Infusion | 4398 ± 33 | 15609 ± 16 | 40080 ± 16 | 50553 ± 24 |
Area under the concentration-time curve from time zero up to time Tau, where Tau is the dosing interval (336 hours).
| h*mcg/mL | EMD 525797 250 mg | EMD 525797 500 mg | EMD 525797 1000 mg | EMD 525797 1500 mg |
|---|---|---|---|---|
| Area Under the Serum Concentration-time Curve Within One Complete Dosing Interval (AUCtau) of EMD 525797 After Third Infusion | 6028 ± 50 | 20306 ± 35 | 67160 ± 19 | 85401 ± 25 |
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.
| h*mcg/mL | EMD 525797 250 mg | EMD 525797 500 mg | EMD 525797 1000 mg | EMD 525797 1500 mg |
|---|---|---|---|---|
| Area Under the Serum Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of EMD 525797 After First Infusion | 4152 ± 38 | 18317 ± 26 | 53580 ± 22 | 75408 ± 29 |
The peak trough fluctuation over one dosing interval at steady state, calculated as PTF (%) = ( \[ Cmax - Cmin \] / Cav )\*100
| percentage of fluctuation | EMD 525797 250 mg | EMD 525797 500 mg | EMD 525797 1000 mg | EMD 525797 1500 mg |
|---|---|---|---|---|
| Peak Trough Fluctuation Over One Dosing Interval at Steady State (%PTF) of EMD 525797 After Third Infusion | 326 ± 39 | 179 ± 43 | 145 ± 18 | 190 ± 32 |
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.
| hours | EMD 525797 250 mg | EMD 525797 500 mg | EMD 525797 1000 mg | EMD 525797 1500 mg |
|---|---|---|---|---|
| Mean Residence Time of Drug in the Body (MRT) of EMD 525797 After First Infusion | 87.2 ± 33.3 | 171.0 ± 26.6 | 230.5 ± 41.3 | 299.9 ± 16.2 |
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.
| Liters | EMD 525797 250 mg | EMD 525797 500 mg | EMD 525797 1000 mg | EMD 525797 1500 mg |
|---|---|---|---|---|
| Apparent Volume of Distribution at Steady State (Vss) of EMD 525797 After Third Infusion | 4.63 ± 24.42 | 4.35 ± 3.79 | 3.35 ± 10.55 | 4.32 ± 29.04 |
Accumulation ratio for Cmax was calculated as Cmax, after third dose/Cmax, after first dose.
| ratio | EMD 525797 250 mg | EMD 525797 500 mg | EMD 525797 1000 mg | EMD 525797 1500 mg |
|---|---|---|---|---|
| Accumulation Ratio Of Cmax (R_Cmax) | 1.10 ± 15.13 | 1.19 ± 18.25 | 1.25 ± 9.84 | 1.32 ± 14.59 |
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.
| ratio | EMD 525797 250 mg | EMD 525797 500 mg | EMD 525797 1000 mg | EMD 525797 1500 mg |
|---|---|---|---|---|
| Accumulation Ratio of AUC (R_AUC) | 1.37 ± 29.43 | 1.32 ± 28.35 | 1.68 ± 18.91 | 1.69 ± 10.31 |
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.
| subjects | EMD 525797 250 mg | EMD 525797 500 mg | EMD 525797 1000 mg | EMD 525797 1500 mg |
|---|---|---|---|---|
| Week 6: CR | 0 | 0 | 0 | 0 |
| Week 6: PR | 0 | 0 | 0 | 0 |
| Week 6: SD | 4 | 5 | 4 | 5 |
| Week 6: PD | 4 | 1 | 2 | 1 |
| Week 19: CR | 0 | 0 | 0 | 0 |
| Week 19: PR | 0 | 1 | 0 | 0 |
| Week 19: SD | 4 | 4 | 4 | 5 |
| Week 19: PD | 4 | 1 | 2 | 1 |
| Overall: CR | 0 | 0 | 0 | 0 |
| Overall: PR | 0 | 1 | 0 | 0 |
| Overall: SD | 4 | 4 | 4 | 5 |
| Overall: PD | 4 | 1 | 2 | 1 |
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).
| months | EMD 525797 250 mg | EMD 525797 500 mg | EMD 525797 1000 mg | EMD 525797 1500 mg |
|---|---|---|---|---|
| PCWG1 | NA (1.4 to NA) | 1.0 (1.0 to 1.4) | 2.3 (1.4 to 2.3) | 7.5 (2.6 to 7.5) |
| PCWG2 | 3.0 (1.7 to 3.7) | 3.4 (1.8 to NA) | 3.9 (2.0 to 4.7) | 3.4 (2.3 to 5.4) |
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.
| months | EMD 525797 250 mg | EMD 525797 500 mg | EMD 525797 1000 mg | EMD 525797 1500 mg |
|---|---|---|---|---|
| Subject 1 | 1.18 | 4.17 | 1.28 | 2.83 |
| Subject 2 | 3.02 | 1.18 | 1.25 | 1.18 |
| Subject 3 | 1.48 | NA | NA | NA |
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.
| subjects | EMD 525797 250 mg | EMD 525797 500 mg | EMD 525797 1000 mg | EMD 525797 1500 mg |
|---|---|---|---|---|
| Baseline score 0, worst post-baseline score 0 | 2 | 3 | 2 | 1 |
| Baseline score 0, worst post-baseline score 1 | 1 | 0 | 1 | 0 |
| Baseline score 0, worst post-baseline score 2 | 0 | 0 | 0 | 1 |
| Baseline score 0, worst post-baseline score 3 | 0 | 0 | 0 | 1 |
| Baseline score 0, worst post-baseline score 4 | 0 | 0 | 0 | 0 |
| Baseline score 1, worst post-baseline score 0 | 1 | 0 | 0 | 0 |
| Baseline score 1, worst post-baseline score 1 | 2 | 3 | 2 | 1 |
| Baseline score 1, worst post-baseline score 2 | 1 | 0 | 0 | 1 |
| Baseline score 1, worst post-baseline score 3 | 1 | 0 | 0 | 0 |
| Baseline score 1, worst post-baseline score 4 | 0 | 0 | 0 | 0 |
| Baseline score 2, worst post-baseline score 0 | 0 | 0 | 0 | 0 |
| Baseline score 2, worst post-baseline score 1 | 0 | 0 | 0 | 1 |
| Baseline score 2, worst post-baseline score 2 | 0 | 0 | 0 | 0 |
| Baseline score 2, worst post-baseline score 3 | 0 | 0 | 1 | 0 |
| Baseline score 2, worst post-baseline score 4 | 0 | 0 | 0 | 0 |
| Baseline score 3, worst post-baseline score 0 | 0 | 0 | 0 | 0 |
| Baseline score 3, worst post-baseline score 1 | 0 | 0 | 0 | 0 |
| Baseline score 3, worst post-baseline score 2 | 0 | 0 | 0 | 0 |
| Baseline score 3, worst post-baseline score 3 | 0 | 0 | 0 | 0 |
| Baseline score 3, worst post-baseline score 4 | 0 | 0 | 0 | 0 |
| Baseline score 4, worst post-baseline score 0 | 0 | 0 | 0 | 0 |
| Baseline score 4, worst post-baseline score 1 | 0 | 0 | 0 | 0 |
| Baseline score 4, worst post-baseline score 2 | 0 | 0 | 0 | 0 |
| Baseline score 4, worst post-baseline score 3 | 0 | 0 | 0 | 0 |
| Baseline score 4, worst post-baseline score 4 | 0 | 0 | 0 | 0 |
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.
| subjects | EMD 525797 250 mg | EMD 525797 500 mg | EMD 525797 1000 mg | EMD 525797 1500 mg |
|---|---|---|---|---|
| Baseline score 0, best post-baseline score 0 | 3 | 3 | 3 | 3 |
| Baseline score 0, best post-baseline score 1 | 0 | 0 | 0 | 0 |
| Baseline score 0, best post-baseline score 2 | 0 | 0 | 0 | 0 |
| Baseline score 0, best post-baseline score 3 | 0 | 0 | 0 | 0 |
| Baseline score 0, best post-baseline score 4 | 0 | 0 | 0 | 0 |
| Baseline score 1, best post-baseline score 0 | 3 | 2 | 0 | 1 |
| Baseline score 1, best post-baseline score 1 | 1 | 1 | 2 | 1 |
| Baseline score 1, best post-baseline score 2 | 1 | 0 | 0 | 0 |
| Baseline score 1, best post-baseline score 3 | 0 | 0 | 0 | 0 |
| Baseline score 1, best post-baseline score 4 | 0 | 0 | 0 | 0 |
| Baseline score 2, best post-baseline score 0 | 0 | 0 | 0 | 1 |
| Baseline score 2, best post-baseline score 1 | 0 | 0 | 0 | 0 |
| Baseline score 2, best post-baseline score 2 | 0 | 0 | 1 | 0 |
| Baseline score 2, best post-baseline score 3 | 0 | 0 | 0 | 0 |
| Baseline score 2, best post-baseline score 4 | 0 | 0 | 0 | 0 |
| Baseline score 3, best post-baseline score 0 | 0 | 0 | 0 | 0 |
| Baseline score 3, best post-baseline score 1 | 0 | 0 | 0 | 0 |
| Baseline score 3, best post-baseline score 2 | 0 | 0 | 0 | 0 |
| Baseline score 3, best post-baseline score 3 | 0 | 0 | 0 | 0 |
| Baseline score 3, best post-baseline score 4 | 0 | 0 | 0 | 0 |
| Baseline score 4, best post-baseline score 0 | 0 | 0 | 0 | 0 |
| Baseline score 4, best post-baseline score 1 | 0 | 0 | 0 | 0 |
| Baseline score 4, best post-baseline score 2 | 0 | 0 | 0 | 0 |
| Baseline score 4, best post-baseline score 3 | 0 | 0 | 0 | 0 |
| Baseline score 4, best post-baseline score 4 | 0 | 0 | 0 | 0 |
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.
| score on a scale | EMD 525797 250 mg | EMD 525797 500 mg | EMD 525797 1000 mg | EMD 525797 1500 mg |
|---|---|---|---|---|
| Screening | 2.32 ± 2.34 | 1.95 ± 1.29 | 1.95 ± 2.15 | 2.52 ± 3.13 |
| Baseline | 1.73 ± 1.57 | 1.64 ± 1.80 | 1.71 ± 1.88 | 2.62 ± 3.84 |
| Week 3 | 1.98 ± 1.98 | 2.57 ± 1.79 | 2.24 ± 1.82 | 1.87 ± 2.48 |
| Week 5 | 2.21 ± 2.27 | 2.29 ± 2.32 | 2.36 ± 2.73 | 1.86 ± 2.43 |
| Week 7 | 2.38 ± 2.92 | 2.17 ± 1.62 | 2.31 ± 3.06 | 1.86 ± 1.92 |
| FUP Week 11 | 0.00 ± NA | 3.00 ± 0.87 | 1.33 ± 1.73 | 4.75 ± 3.17 |
| FUP Week 15 | — | 2.68 ± 0.65 | 2.21 ± 2.73 | 3.43 ± 4.85 |
| FUP Week 19 | — | 3.33 ± 1.95 | 0.57 ± NA | 3.29 ± 3.43 |
| FUP Week 23 | — | 2.36 ± 0.51 | 1.00 ± NA | 2.57 ± 3.64 |
| FUP Week 27 | — | 1.57 ± 0.40 | 1.00 ± NA | 1.57 ± NA |
| FUP Week 31 | — | 1.93 ± 0.51 | 1.00 ± NA | 0.00 ± NA |
| FUP Week 35 | — | 2.29 ± 0.20 | 1.14 ± NA | — |
| FUP Week 39 | — | 2.50 ± 0.51 | 1.43 ± NA | — |
| FUP Week 43 | — | 5.00 ± 3.03 | 1.86 ± NA | — |
| FUP Week 47 | — | 2.00 ± NA | — | — |
| FUP Week 51 | — | 3.00 ± NA | — | — |
| FUP Week 55 | — | 3.00 ± NA | — | — |
| FUP Week 59 | — | 2.71 ± NA | — | — |
| FUP Week 63 | — | 2.57 ± NA | — | — |
| FUP Week 67 | — | 2.43 ± NA | — | — |
| FUP Week 71 | — | 2.29 ± NA | — | — |
| FUP Week 75 | — | 2.43 ± NA | — | — |
| EOT | 2.19 ± 2.76 | 3.36 ± 3.74 | 1.50 ± 0.10 | 3.41 ± 1.24 |
| EOS | 1.86 ± 3.22 | 3.63 ± 3.70 | 2.82 ± 2.22 | 2.71 ± 2.12 |
Maximum percent change from Baseline in PSA Level during the study was reported.
| percent change | EMD 525797 250 mg | EMD 525797 500 mg | EMD 525797 1000 mg | EMD 525797 1500 mg |
|---|---|---|---|---|
| Maximum Percent Change From Baseline in Prostate Specific Antigen (PSA) Level | 138.41 ± 234.40 | 580.32 ± 1083.12 | 120.76 ± 108.18 | 120.41 ± 159.14 |
Minimum percent change from Baseline in PSA Level during the study was reported.
| percent change | EMD 525797 250 mg | EMD 525797 500 mg | EMD 525797 1000 mg | EMD 525797 1500 mg |
|---|---|---|---|---|
| Minimum Percent Change From Baseline in PSA Level | 8.69 ± 21.91 | -9.88 ± 63.59 | 17.94 ± 9.16 | -7.72 ± 34.74 |
Collected over Baseline up to 394 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| EMD 525797 250 mg | — | 5/8 (62.5%) | 8/8 (100%) |
| EMD 525797 500 mg | — | 1/6 (16.7%) | 6/6 (100%) |
| EMD 525797 1000 mg | — | 4/6 (66.7%) | 6/6 (100%) |
| EMD 525797 1500 mg | — | 3/6 (50%) | 6/6 (100%) |
| Event | EMD 525797 250 mg | EMD 525797 500 mg | EMD 525797 1000 mg | EMD 525797 1500 mg |
|---|---|---|---|---|
| AnaemiaBlood and lymphatic system disorders | 0/8 | 0/6 | 1/6 | 0/6 |
| Anaemia Of Malignant DiseaseBlood and lymphatic system disorders | 0/8 | 0/6 | 1/6 | 0/6 |
| NauseaGastrointestinal disorders | 0/8 | 0/6 | 0/6 | 1/6 |
| PancreatitisGastrointestinal disorders | 0/8 | 0/6 | 0/6 | 1/6 |
| EuthanasiaGeneral disorders | 0/8 | 0/6 | 1/6 | 0/6 |
| PyrexiaGeneral disorders | 0/8 | 1/6 | 0/6 | 0/6 |
| Bile Duct StoneHepatobiliary disorders | 0/8 | 0/6 | 0/6 | 1/6 |
| SepsisInfections and infestations | 0/8 | 0/6 | 1/6 | 0/6 |
| Urinary Tract InfectionInfections and infestations | 0/8 | 0/6 | 1/6 | 1/6 |
| Back PainMusculoskeletal and connective tissue disorders | 0/8 | 0/6 | 1/6 | 0/6 |
| Event | EMD 525797 250 mg | EMD 525797 500 mg | EMD 525797 1000 mg | EMD 525797 1500 mg |
|---|---|---|---|---|
| FatigueGeneral disorders | 1/8 | 0/6 | 2/6 | 2/6 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 1/8 | 2/6 | 1/6 | 0/6 |
| Bone PainMusculoskeletal and connective tissue disorders | 0/8 | 0/6 | 1/6 | 2/6 |
| Musculoskeletal PainMusculoskeletal and connective tissue disorders | 0/8 | 0/6 | 0/6 | 2/6 |
| Pain In ExtremityMusculoskeletal and connective tissue disorders | 0/8 | 2/6 | 1/6 | 1/6 |
| ErythemaSkin and subcutaneous tissue disorders | 0/8 | 0/6 | 2/6 | 0/6 |
| Oedema PeripheralGeneral disorders | 2/8 | 1/6 | 0/6 | 0/6 |
| Urinary Tract InfectionInfections and infestations | 2/8 | 0/6 | 0/6 | 0/6 |
| Back PainMusculoskeletal and connective tissue disorders | 2/8 | 1/6 | 1/6 | 0/6 |
| Muscular WeaknessMusculoskeletal and connective tissue disorders | 2/8 | 0/6 | 0/6 | 0/6 |
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.
| Age, Continuous(years) | EMD 525797 250 mg | EMD 525797 500 mg | EMD 525797 1000 mg | EMD 525797 1500 mg | Total |
|---|---|---|---|---|---|
| Mean | 67.0 ± 6.0 | 63.0 ± 12.0 | 62.0 ± 12.0 | 66.0 ± 9.0 | 65.0 ± 9.0 |
| Sex: Female, Male(Participants) | EMD 525797 250 mg | EMD 525797 500 mg | EMD 525797 1000 mg | EMD 525797 1500 mg | Total |
|---|---|---|---|---|---|
| Female | 0 | 0 | 0 | 0 | 0 |
| Male | 8 | 6 | 6 | 6 | 26 |
The record gives a start of Oct 2008, a primary completion of Sep 2010 and a completion of Mar 2011. It does not say whether these dates are actual or estimated.
Results were first posted in Aug 2017, 6 years 11 months after primary completion.
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Studies of the drug tested here: Abituzumab
Merck KGaA, Darmstadt, Germany →