Trial · NCT00958477
A Study to Determine the Safety, Tolerability, Pharmacokinetics and Dynamic Effects of Different Doses of the Study Drug EMD 525797 in Prostate Cancer
NCT00958477, Phase 1, Completed, Merck KGaA, Darmstadt, Germany; results first posted 2017-08-02
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Study to Determine the Safety, Tolerability, Pharmacokinetics and Dynamic Effects of Different Doses of the Study Drug EMD 525797 in Prostate Cancer. Trials, record NCT00958477. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00958477
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Determine the Safety, Tolerability, Pharmacokinetics and Dynamic Effects of Different Doses of the Study Drug EMD 525797 in Prostate Cancer
- NCT number
- NCT00958477
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 26 participants, actual
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Conditions
- Prostate Cancer, Bone Metastases
- Interventions
- EMD 525797
- First posted
- 2009-08-13
- Last updated
- 2017-08-02
- Results first posted
- 2017-08-02
Source ClinicalTrials.gov
Registered outcomes35
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects With Dose Limiting Toxicity (DLT) | Baseline up to 6 weeks | 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. |
| Primary | Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and Related TEAEs | Baseline up to 534 days | 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. |
| Primary | Observed Maximum Serum Concentration (Cmax) of EMD 525797 After First Infusion | pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 1 | |
| Primary | Observed Maximum Serum Concentration (Cmax) of EMD 525797 After Third Infusion | pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 5 | |
| Primary | Area Under the Serum Concentration-time Curve From Time Zero to the Last Sampling Time (AUC0-t) After First Infusion | pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 1 | 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. |
| Primary | Total Body Clearance of Drug From Serum (CL) After First Infusion | pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 1 | 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. |
| Primary | Apparent Volume of Distribution During Terminal Phase (Vz) of EMD 525797 After First Infusion | pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 1 | 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. |
| Primary | Trough Serum Concentration (Ctrough) Of EMD 525797 at Week 1 | pre-dose at Week 1 | Ctrough is the concentration prior to study drug administration. |
| Primary | Trough Serum Concentration (Ctrough) Of EMD 525797 at Week 3 | pre-dose at Week 3 | Ctrough is the concentration prior to study drug administration. |
| Primary | Trough Serum Concentration (Ctrough) Of EMD 525797 at Week 5 | pre-dose at Week 5 | Ctrough is the concentration prior to study drug administration. |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 registered outcomesOutcomes35
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Subjects With Dose Limiting Toxicity (DLT) | Baseline up to 6 weeks | DLT analysis set: all subjects who experienced any DLT during first 6 weeks, regardless of number of doses of drug administered or who were considered completers (did not discontinue treatment for any reason other than DLT, were compliant, did not deviate in drug administration for more than +/-2 days due to any reason other than related toxicity). | subjects | NUMBER |
| PRIMARY | Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and Related TEAEs | Baseline up to 534 days | 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. | Subjects | NUMBER |
| PRIMARY | Observed Maximum Serum Concentration (Cmax) of EMD 525797 After First Infusion | pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 1 | Pharmacokinetic (PK) analysis set included all subjects who received at least first dose of the study drug according to the protocol and who provided sufficient data for a concentration time profile for EMD 525797.Here Number of Participants analyzed signifies those subjects who were evaluable for this outcome measure for each arm, respectively. | microgram per milliliter (mcg/mL) | GEOMETRIC_MEAN |
| PRIMARY | Observed Maximum Serum Concentration (Cmax) of EMD 525797 After Third Infusion | pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 5 | PK analysis set included all subjects who received at least the first dose of the study drug according to the protocol and who provided sufficient data for a concentration time profile for EMD 525797. Here Number of Participants analyzed signifies those subjects who were evaluable for this outcome measure for each arm, respectively. | mcg/mL | GEOMETRIC_MEAN |
| PRIMARY | Area Under the Serum Concentration-time Curve From Time Zero to the Last Sampling Time (AUC0-t) After First Infusion | pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 1 | PK analysis set included all subjects who received at least the first dose of the study drug according to the protocol and who provided sufficient data for a concentration time profile for EMD 525797. Here Number of Participants analyzed signifies those subjects who were evaluable for this outcome measure for each arm, respectively. | h*mcg/mL | GEOMETRIC_MEAN |
| PRIMARY | Total Body Clearance of Drug From Serum (CL) After First Infusion | pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 1 | PK analysis set included all subjects who received at least the first dose of the study drug according to the protocol and who provided sufficient data for a concentration time profile for EMD 525797. Here Number of Participants analyzed signifies those subjects who were evaluable for this outcome measure for each arm, respectively. | L/h | GEOMETRIC_MEAN |
| PRIMARY | Apparent Volume of Distribution During Terminal Phase (Vz) of EMD 525797 After First Infusion | pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 1 | PK analysis set included all subjects who received at least the first dose of the study drug according to the protocol and who provided sufficient data for a concentration time profile for EMD 525797. Here Number of Participants analyzed signifies those subjects who were evaluable for this outcome measure for each arm, respectively. | Liters | GEOMETRIC_MEAN |
| PRIMARY | Trough Serum Concentration (Ctrough) Of EMD 525797 at Week 1 | pre-dose at Week 1 | PK analysis set included all subjects who received at least the first dose of the study drug according to the protocol and who provided sufficient data for a concentration time profile for EMD 525797. Here Number of Participants analyzed signifies those subjects who were evaluable for this outcome measure for each arm, respectively. | mcg/mL | MEAN |
| PRIMARY | Trough Serum Concentration (Ctrough) Of EMD 525797 at Week 3 | pre-dose at Week 3 | PK analysis set included all subjects who received at least the first dose of the study drug according to the protocol and who provided sufficient data for a concentration time profile for EMD 525797. Here Number of Participants analyzed signifies those subjects who were evaluable for this outcome measure for each arm, respectively. | mcg/mL | MEAN |
| PRIMARY | Trough Serum Concentration (Ctrough) Of EMD 525797 at Week 5 | pre-dose at Week 5 | PK analysis set included all subjects who received at least the first dose of the study drug according to the protocol and who provided sufficient data for a concentration time profile for EMD 525797. Here Number of Participants analyzed signifies those subjects who were evaluable for this outcome measure for each arm, respectively. | mcg/mL | MEAN |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 outcomesResults by group461
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Subjects With Dose Limiting Toxicity (DLT) | EMD 525797 250 mg | 0 | subjects | ||
| Number of Subjects With Dose Limiting Toxicity (DLT) | EMD 525797 500 mg | 0 | subjects | ||
| Number of Subjects With Dose Limiting Toxicity (DLT) | EMD 525797 1000 mg | 0 | subjects | ||
| Number of Subjects With Dose Limiting Toxicity (DLT) | EMD 525797 1500 mg | 0 | subjects | ||
| Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and Related TEAEs | EMD 525797 250 mg | TEAEs | 8 | Subjects | |
| Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and Related TEAEs | EMD 525797 500 mg | TEAEs | 6 | Subjects | |
| Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and Related TEAEs | EMD 525797 1000 mg | TEAEs | 6 | Subjects | |
| Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and Related TEAEs | EMD 525797 1500 mg | TEAEs | 6 | Subjects | |
| Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and Related TEAEs | EMD 525797 250 mg | Serious TEAEs | 5 | Subjects | |
| Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and Related TEAEs | EMD 525797 500 mg | Serious TEAEs | 1 | Subjects |
1 to 10 of 461Source ClinicalTrials.gov
See all 461 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | EMD 525797 250 mg | 8 | |
| Overall Study | STARTED | EMD 525797 500 mg | 6 | |
| Overall Study | STARTED | EMD 525797 1000 mg | 6 | |
| Overall Study | STARTED | EMD 525797 1500 mg | 6 | |
| Overall Study | COMPLETED | EMD 525797 250 mg | 8 | |
| Overall Study | COMPLETED | EMD 525797 500 mg | 6 | |
| Overall Study | COMPLETED | EMD 525797 1000 mg | 6 | |
| Overall Study | COMPLETED | EMD 525797 1500 mg | 6 | |
| Overall Study | NOT COMPLETED | EMD 525797 250 mg | 0 | |
| Overall Study | NOT COMPLETED | EMD 525797 500 mg | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events372
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | EMD 525797 250 mg | 0 | 8 | |
| other | Anaemia | Blood and lymphatic system disorders | EMD 525797 500 mg | 0 | 6 | |
| other | Anaemia | Blood and lymphatic system disorders | EMD 525797 1000 mg | 1 | 6 | |
| other | Anaemia | Blood and lymphatic system disorders | EMD 525797 1500 mg | 1 | 6 | |
| other | Leukopenia | Blood and lymphatic system disorders | EMD 525797 250 mg | 1 | 8 | |
| other | Leukopenia | Blood and lymphatic system disorders | EMD 525797 500 mg | 0 | 6 | |
| other | Leukopenia | Blood and lymphatic system disorders | EMD 525797 1000 mg | 0 | 6 | |
| other | Leukopenia | Blood and lymphatic system disorders | EMD 525797 1500 mg | 0 | 6 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | EMD 525797 250 mg | 0 | 8 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | EMD 525797 500 mg | 1 | 6 |
1 to 10 of 372Source ClinicalTrials.gov
See all 372 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | EMD 525797 250 mg | ||
| Total, all-cause mortality | EMD 525797 500 mg | ||
| Total, all-cause mortality | EMD 525797 1000 mg | ||
| Total, all-cause mortality | EMD 525797 1500 mg | ||
| Total, other adverse events | EMD 525797 250 mg | 8 | 8 |
| Total, other adverse events | EMD 525797 500 mg | 6 | 6 |
| Total, other adverse events | EMD 525797 1000 mg | 6 | 6 |
| Total, other adverse events | EMD 525797 1500 mg | 6 | 6 |
| Total, serious adverse events | EMD 525797 250 mg | 5 | 8 |
| Total, serious adverse events | EMD 525797 500 mg | 1 | 6 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23791392 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00958477
GET https://conductscience.org/api/trials/v1/NCT00958477/registered?page=2