Trial · NCT00958477
Registered outcomes35
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 35
Download this page as JSON| 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. |
| Secondary | Time to Reach Observed Serum Concentration (Tmax) After First Infusion | pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 1 | |
| Secondary | Time to Reach Observed Serum Concentration (Tmax) After Third Infusion | pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 5 | |
| Secondary | Number of Subjects With Positive Anti-EMD 525797 Antibodies | Week 1, 3, 5, 8, 9 | |
| Secondary | Serum Levels of Interleukin 6 (IL-6) and Interleukin 8 (IL-8) | Week 1 up to a maximum of 56 days | |
| Secondary | C-Reactive Protein Levels | Week 1 up to a maximum of 56 days | |
| Secondary | Apparent Terminal Half-life (t1/2) 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 | 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. |
| Secondary | Elimination Rate Constant (λz) 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 | Elimination rate constant obtained from linear regression of the terminal phase of the log transformed concentration-time data. |
| Secondary | Observed Minimum Serum Concentration (Cmin) 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 | Observed minimum serum concentration determined directly from the serum concentration-time profile of each subject. |
| Secondary | Average Serum Concentration at Steady State (Cav) of EMD 525797 After Third Infusion | pre-dose, end of infusion, 4, 8, 24, 48, 96, 168, 336 hours post third infusion at Week 5 | The average serum concentration at steady state, calculated as Cav = AUCtau/tau, where tau is the dosing interval (336 hours). |
| Secondary | Area Under the Serum Concentration-time Curve Within One Complete Dosing Interval (AUCtau) of EMD 525797 After First Infusion | pre-dose, end of infusion, 4, 8, 24, 48, 96 and 168 hours post-infusion at Week 1 | Area under the concentration-time curve from time zero up to time Tau, where Tau is the dosing interval (168 hours). |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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